The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial
NCT ID: NCT07156188
Last Updated: 2025-09-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
914 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-01
Study Completion Date
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Umbilical hernias can be found in over a quarter of the population and comprise of 15% of hernia repairs performed in Canada. While mesh repair is commonly used for larger hernias, smaller hernia defects are often closed with sutures alone. While non-absorbable sutures may have greater tensile strength, the use of absorbable sutures has been found to reduce the risk for wound infection and improve healing. The objective of this multi-centre, nationwide randomized controlled study is to determine whether there is a difference in hernia recurrence when the repair is completed with absorbable polydioxanone suture versus permanent polypropylene suture. The study will also explore post-operative complications and quality of life. Recruitment will take place over 5 years with follow-up at the 30-day, 12-month and 24-month mark following surgery. The results of this trial will be directly applicable to national and international hernia guidelines and will impact the care of thousands of patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh
NCT05994248
Umbilical Hernia
WITHDRAWN
NA
Mesh Versus Suture Repair for Umbilical Hernias
NCT00789230
Umbilical Hernia
COMPLETED
NA
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures
NCT01467830
Inguinal Hernia
WITHDRAWN
NA
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
NCT04591860
Hiatal Hernia
NOT_YET_RECRUITING
NA
Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair
NCT01607801
Umbilical Hernia
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Umbilical hernias make up a notable proportion of abdominal wall hernia repairs annually. Up to 25% of the population have asymptomatic umbilical hernias when examined using ultrasound. Recent computed tomography studies have identified umbilical hernia in up to 62% of the population. In Canada in 2019, there were 66,234 hernia surgeries performed. Similarly, there are around 175,000 umbilical hernia repairs per year in the United States.
The European Hernia Society (EHS) guidelines classify umbilical hernias by size as small (0-1cm), medium (more than 1 cm up to 4cm), and large (over 4 cm) based on diameter. Although many hernias are asymptomatic, intra-abdominal contents, such as fat or bowel, can protrude through the defect and result in a surgical emergency. Up to 20% of patients with asymptomatic umbilical hernia will later require elective surgery, and another 4% will require emergency surgery.
The EHS guidelines recommend mesh for all hernia repairs to reduce rate of recurrence, but quality of evidence is limited for hernias less than 1cm in size and therefore suture repair can be considered in these situations. Despite EHS guidelines, in many cases, umbilical hernias up to 2 cm in size are repaired with suture based on intra-operative assessment, for example, to avoid enlarging the defect necessary to accommodate a pre-peritoneal mesh with an overlap of 3cm.
The Americas Hernia Society Quality Collaborative Database found that mesh repairs were used for 82% of umbilical hernias \>1cm in diameter and 33% of those ≤1cm in diameter. For the National Health Service in England, 50% of umbilical hernias were repaired with mesh. This has led to the controversial reclassification of small hernias to those \<2cm in size. Of small (\<2cm) umbilical hernias captured by Herniamed, a hernia registry in Germany, Austria, and Switzerland, suture repair was performed for 76.5% of all cases.
The double-blind multicentre randomized controlled trial by Kauffmann and colleagues. compared suture to mesh repair of primary umbilical hernias and found an 8% recurrence rate following suture repair of umbilical hernias 1-2cm in size.
Based on clinical experience, there does appear to be higher rates of granuloma formation, sinus tract formation, and wound complications following the use of non-absorbable sutures. A systematic review and meta-analysis of techniques for the closure of midline abdominal incisions compared absorbable and non-absorbable suture and identified increased pain and suture sinus formation with the use of non-absorbable suture. Another systematic review comparing slowly absorbable versus non-absorbable suture for laparotomy fascial closure found no difference in hernia rate, but a higher rate of suture sinus formation after using non-absorbable suture. Rat models have also demonstrated that slowly absorbable polydioxanone suture may be preferable to permanent polypropylene suture due to a favourable macrophage response. Two large Danish studies compared non-absorbable, slowly absorbable, and quickly absorbable sutures and found no significant difference in recurrence rates.
There is currently insufficient evidence to recommend a suture type or technique for the suture repair of small umbilical hernias. The PAPYRUS Trial will help guide surgical management and suture decisions for thousands of patients annually in North America.
Common umbilical hernia repair complications include wound infection, pain, or hematoma. Multiple terms exist to describe complications following hernia surgery, and the Ventral Hernia Working Group has endeavoured to standardize this nomenclature by defining surgical site occurrence (SSO) and surgical site occurrences requiring procedural intervention (SSOPI). The PAPYRUS Trial will utilize these metrics as outcome variables because SSO will capture suture complications.
Suture type may play a role in reducing risk of recurrence and post-operative complications following primary suture repair of umbilical hernia. There have been no recent systematic reviews or meta-analyses comparing suture types for umbilical hernia. In the systematic review comparing mesh versus suture for elective repair of umbilical hernia, the studies using slowly absorbable suture may favour suture repair, whereas those using permanent suture may favour mesh repair. The European Hernia Society Guidelines state that there is insufficient clinical literature to determine whether permanent or absorbable suture should be used for the primary open repair of small umbilical hernias. This trial is needed to guide the best practices on the use of suture type when performing suture repair of primary umbilical hernia.
The results of this trial will add to the limited evidence base of the surgical management of umbilical hernias ≤2 cm in size and inform treatment guidelines for suture selection in the management of suture repair for primary umbilical hernia. This trial will guide surgical decisions on preferred suture material for primary umbilical hernia repair based on differences or lack of differences in recurrence, SSO, SSOPI, and patient-reported QoL.
Thus, the research question for this trial is: Does slowly absorbable polydioxanone suture compared to permanent polypropylene suture for primary open repair of small \<2 cm umbilical hernias result in non-inferior recurrence, SSO, SSOPI, or QoL at 24 months following surgery?
The primary hypothesis is that slowly absorbable polydioxanone suture will be non-inferior (at a non-inferiority margin of 5%) to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias for recurrence at 24 months.
Secondary hypotheses are:
1. Slowly absorbable polydioxanone suture is non-inferior to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias for SSO and SSOPI at 24 months post-operatively.
Slowly absorbable polydioxanone suture is non-inferior to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias in patient-reported QoL as measured by the HerQLes and the SF-12 surveys at 24 months.
All analyses will be conducted on the intention-to-treat (ITT) population. Continuous data will be expressed as means and standard deviations and analyzed using two-sample t-test. Categorical data will be expressed as contingency tables using counts and percentages and analyzed using Chi-squared test or Fisher's exact test.
Recurrence, SSO, and SSOPI will be analyzed as follows:
* Descriptive statistics using Chi-squared test at 30 days, 12 months and 2 years
* Kaplan-Meier survival analysis at 30 days, 12 months and 2 years
* Log-rank test to compare differences in survival distributions
* Cox proportional hazards model to adjust for covariates and obtain estimates for hazard ratio and 95% confidence interval
HerQLes and SF-12 scores:
• Differences between preoperative and postoperative HerQLes and SF-12 scores at 30 days, 12 months, and 2 years will be first evaluated using repeated measures ANOVA. If significant overall event is detected, then pairwise comparisons using paired t-test at 30 days, 12 months, and 2 years with Bonferroni correction will be conducted.
Subgroup analyses will be conducted to evaluate differences in hernia risk factors and sites. All analyses will be conducted using R Statistical Software (v4.5.0; Vienna, Austria).
The European Hernia Society (EHS) guidelines classify umbilical hernias by size as small (0-1cm), medium (more than 1 cm up to 4cm), and large (over 4 cm) based on diameter. Although many hernias are asymptomatic, intra-abdominal contents, such as fat or bowel, can protrude through the defect and result in a surgical emergency. Up to 20% of patients with asymptomatic umbilical hernia will later require elective surgery, and another 4% will require emergency surgery.
The EHS guidelines recommend mesh for all hernia repairs to reduce rate of recurrence, but quality of evidence is limited for hernias less than 1cm in size and therefore suture repair can be considered in these situations. Despite EHS guidelines, in many cases, umbilical hernias up to 2 cm in size are repaired with suture based on intra-operative assessment, for example, to avoid enlarging the defect necessary to accommodate a pre-peritoneal mesh with an overlap of 3cm.
The Americas Hernia Society Quality Collaborative Database found that mesh repairs were used for 82% of umbilical hernias \>1cm in diameter and 33% of those ≤1cm in diameter. For the National Health Service in England, 50% of umbilical hernias were repaired with mesh. This has led to the controversial reclassification of small hernias to those \<2cm in size. Of small (\<2cm) umbilical hernias captured by Herniamed, a hernia registry in Germany, Austria, and Switzerland, suture repair was performed for 76.5% of all cases.
The double-blind multicentre randomized controlled trial by Kauffmann and colleagues. compared suture to mesh repair of primary umbilical hernias and found an 8% recurrence rate following suture repair of umbilical hernias 1-2cm in size.
Based on clinical experience, there does appear to be higher rates of granuloma formation, sinus tract formation, and wound complications following the use of non-absorbable sutures. A systematic review and meta-analysis of techniques for the closure of midline abdominal incisions compared absorbable and non-absorbable suture and identified increased pain and suture sinus formation with the use of non-absorbable suture. Another systematic review comparing slowly absorbable versus non-absorbable suture for laparotomy fascial closure found no difference in hernia rate, but a higher rate of suture sinus formation after using non-absorbable suture. Rat models have also demonstrated that slowly absorbable polydioxanone suture may be preferable to permanent polypropylene suture due to a favourable macrophage response. Two large Danish studies compared non-absorbable, slowly absorbable, and quickly absorbable sutures and found no significant difference in recurrence rates.
There is currently insufficient evidence to recommend a suture type or technique for the suture repair of small umbilical hernias. The PAPYRUS Trial will help guide surgical management and suture decisions for thousands of patients annually in North America.
Common umbilical hernia repair complications include wound infection, pain, or hematoma. Multiple terms exist to describe complications following hernia surgery, and the Ventral Hernia Working Group has endeavoured to standardize this nomenclature by defining surgical site occurrence (SSO) and surgical site occurrences requiring procedural intervention (SSOPI). The PAPYRUS Trial will utilize these metrics as outcome variables because SSO will capture suture complications.
Suture type may play a role in reducing risk of recurrence and post-operative complications following primary suture repair of umbilical hernia. There have been no recent systematic reviews or meta-analyses comparing suture types for umbilical hernia. In the systematic review comparing mesh versus suture for elective repair of umbilical hernia, the studies using slowly absorbable suture may favour suture repair, whereas those using permanent suture may favour mesh repair. The European Hernia Society Guidelines state that there is insufficient clinical literature to determine whether permanent or absorbable suture should be used for the primary open repair of small umbilical hernias. This trial is needed to guide the best practices on the use of suture type when performing suture repair of primary umbilical hernia.
The results of this trial will add to the limited evidence base of the surgical management of umbilical hernias ≤2 cm in size and inform treatment guidelines for suture selection in the management of suture repair for primary umbilical hernia. This trial will guide surgical decisions on preferred suture material for primary umbilical hernia repair based on differences or lack of differences in recurrence, SSO, SSOPI, and patient-reported QoL.
Thus, the research question for this trial is: Does slowly absorbable polydioxanone suture compared to permanent polypropylene suture for primary open repair of small \<2 cm umbilical hernias result in non-inferior recurrence, SSO, SSOPI, or QoL at 24 months following surgery?
The primary hypothesis is that slowly absorbable polydioxanone suture will be non-inferior (at a non-inferiority margin of 5%) to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias for recurrence at 24 months.
Secondary hypotheses are:
1. Slowly absorbable polydioxanone suture is non-inferior to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias for SSO and SSOPI at 24 months post-operatively.
Slowly absorbable polydioxanone suture is non-inferior to permanent polypropylene suture for primary repair of small (≤2cm) umbilical hernias in patient-reported QoL as measured by the HerQLes and the SF-12 surveys at 24 months.
All analyses will be conducted on the intention-to-treat (ITT) population. Continuous data will be expressed as means and standard deviations and analyzed using two-sample t-test. Categorical data will be expressed as contingency tables using counts and percentages and analyzed using Chi-squared test or Fisher's exact test.
Recurrence, SSO, and SSOPI will be analyzed as follows:
* Descriptive statistics using Chi-squared test at 30 days, 12 months and 2 years
* Kaplan-Meier survival analysis at 30 days, 12 months and 2 years
* Log-rank test to compare differences in survival distributions
* Cox proportional hazards model to adjust for covariates and obtain estimates for hazard ratio and 95% confidence interval
HerQLes and SF-12 scores:
• Differences between preoperative and postoperative HerQLes and SF-12 scores at 30 days, 12 months, and 2 years will be first evaluated using repeated measures ANOVA. If significant overall event is detected, then pairwise comparisons using paired t-test at 30 days, 12 months, and 2 years with Bonferroni correction will be conducted.
Subgroup analyses will be conducted to evaluate differences in hernia risk factors and sites. All analyses will be conducted using R Statistical Software (v4.5.0; Vienna, Austria).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Hernia Surgery
Umbilical Hernia Repair
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The PAPYRUS Trial is the first Canada-wide, multi-centre, prospective, parallel arm, non-inferiority, single blind randomized controlled trial of patients undergoing elective suture repair of small (≤2cm) primary umbilical hernia comparing non-absorbable (polypropylene) suture control group versus absorbable (polydioxanone) suture intervention group. An online web-based central method (built-in on UBC FoM REDCap) will be used for randomization. Randomization must occur intraoperatively to ensure the exclusion criteria that can only be determined during surgery are met and the surgeon confirms defect size. Participants will be followed up at 30 days, 12 months, and 2 years following surgery for assessment. The study visits will be aligned with their standard of care clinic visits.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Permenant Suture
Repair with permanent 0-0 polypropylene suture.
Group Type
ACTIVE_COMPARATOR
Permanent Suture
Intervention Type
OTHER
In both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed in a standardized manner. In the control group, a permanent 0-0 polypropylene suture will be used to close the hernia defect in a transverse or vertical interrupted fashion using either the simple interrupted or the figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.
Absorbable Suture
Repair with an 0-0 polydioxanone suture
Group Type
ACTIVE_COMPARATOR
Absorbable
Intervention Type
OTHER
In both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed. An 0-0 polydioxanone suture (PDS) will be used to close the hernia defect in either a transverse or vertical interrupted fashion using either simple interrupted or figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Permanent Suture
In both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed in a standardized manner. In the control group, a permanent 0-0 polypropylene suture will be used to close the hernia defect in a transverse or vertical interrupted fashion using either the simple interrupted or the figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.
Intervention Type
OTHER
Absorbable
In both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed. An 0-0 polydioxanone suture (PDS) will be used to close the hernia defect in either a transverse or vertical interrupted fashion using either simple interrupted or figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Control
polypropylene
Polydioxanone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Elective surgery for primary umbilical hernia with a defect ≤ 2 cm measured clinically or radiographically
2. Age 19 years or older
3. Patient able to give oral and written informed consent
2. Age 19 years or older
3. Patient able to give oral and written informed consent
Exclusion Criteria
1. Umbilical hernia defect \> 2 cm measured clinically, radiologically, or intraoperatively with ruler
2. Multiple defects
3. Incisional hernia: prior hernia in area of operation
4. Recurrent umbilical hernia
5. Epigastric hernia
6. Secondary operation performed simultaneously
7. Pregnancy
8. Infected wounds
9. Acute operation (incarcerated or strangulated hernia)
10. BMI ≥ 35 kg/m\^2
11. Ascites or liver cirrhosis
12. Peritoneal dialysis
13. Immunosuppression
14. Connective tissue disorder
15. Patient deemed unfit for primary repair at time of surgery based on surgeon discretion at time of operation (e.g. poor tissue quality or unexpected operative finding)
16. Defect is made in the umbilical skin or skin incision extended beyond paraumbilical incision (e.g. sigma or midline extended incision)
2. Multiple defects
3. Incisional hernia: prior hernia in area of operation
4. Recurrent umbilical hernia
5. Epigastric hernia
6. Secondary operation performed simultaneously
7. Pregnancy
8. Infected wounds
9. Acute operation (incarcerated or strangulated hernia)
10. BMI ≥ 35 kg/m\^2
11. Ascites or liver cirrhosis
12. Peritoneal dialysis
13. Immunosuppression
14. Connective tissue disorder
15. Patient deemed unfit for primary repair at time of surgery based on surgeon discretion at time of operation (e.g. poor tissue quality or unexpected operative finding)
16. Defect is made in the umbilical skin or skin incision extended beyond paraumbilical incision (e.g. sigma or midline extended incision)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
North York General Hospital
OTHER
Sponsor Role
collaborator
Royal Victoria Hospital Of Barrie
UNKNOWN
Sponsor Role
collaborator
London Health Sciences Centre
OTHER
Sponsor Role
collaborator
University of Alberta
OTHER
Sponsor Role
collaborator
University of British Columbia
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rachel Liu Hennessey
Clinical Assistant Professor, University of British Columbia; General Surgeon, Vancouver General Hospital
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Alexandra Hospital/University of Alberta
Edmonton, Alberta, Canada
Site Status
Royal Victoria Hospital
Barrie, Ontario, Canada
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
North York General Hospital
North York, Ontario, Canada
Site Status
Vancouver Coastal Health
Vancouver, , Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Wright D, Paterson C, Scott N, Hair A, O'Dwyer PJ. Five-year follow-up of patients undergoing laparoscopic or open groin hernia repair: a randomized controlled trial. Ann Surg. 2002 Mar;235(3):333-7. doi: 10.1097/00000658-200203000-00004.
Reference Type
BACKGROUND
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Reference Type
BACKGROUND
Ventral Hernia Working Group; Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010 Sep;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. Epub 2010 Mar 20.
Reference Type
BACKGROUND
Venclauskas L, Jokubauskas M, Zilinskas J, Zviniene K, Kiudelis M. Long-term follow-up results of umbilical hernia repair. Wideochir Inne Tech Maloinwazyjne. 2017 Dec;12(4):350-356. doi: 10.5114/wiitm.2017.70327. Epub 2017 Sep 26.
Reference Type
BACKGROUND
van Veen RN, Wijsmuller AR, Vrijland WW, Hop WC, Lange JF, Jeekel J. Randomized clinical trial of mesh versus non-mesh primary inguinal hernia repair: long-term chronic pain at 10 years. Surgery. 2007 Nov;142(5):695-8. doi: 10.1016/j.surg.2007.05.019.
Reference Type
BACKGROUND
Sajid MS, Parampalli U, Baig MK, McFall MR. A systematic review on the effectiveness of slowly-absorbable versus non-absorbable sutures for abdominal fascial closure following laparotomy. Int J Surg. 2011;9(8):615-25. doi: 10.1016/j.ijsu.2011.09.006. Epub 2011 Oct 30.
Reference Type
BACKGROUND
Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in 2003. Surg Clin North Am. 2003 Oct;83(5):1045-51, v-vi. doi: 10.1016/S0039-6109(03)00132-4.
Reference Type
BACKGROUND
Renshaw SM, Gupta A, Poulose BK. Establishing the minimal clinically important difference for the Hernia-Related Quality of Life Survey (HerQLes). Am J Surg. 2022 Feb;223(2):245-249. doi: 10.1016/j.amjsurg.2021.06.018. Epub 2021 Jul 2.
Reference Type
BACKGROUND
Pawlak M, Tulloh B, de Beaux A. Current trends in hernia surgery in NHS England. Ann R Coll Surg Engl. 2020 Jan;102(1):25-27. doi: 10.1308/rcsann.2019.0118. Epub 2019 Aug 16.
Reference Type
BACKGROUND
Muysoms F, Campanelli G, Champault GG, DeBeaux AC, Dietz UA, Jeekel J, Klinge U, Kockerling F, Mandala V, Montgomery A, Morales Conde S, Puppe F, Simmermacher RK, Smietanski M, Miserez M. EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair. Hernia. 2012 Jun;16(3):239-50. doi: 10.1007/s10029-012-0912-7. Epub 2012 Apr 18.
Reference Type
BACKGROUND
Melkemichel M, Bringman S, Granasen G, Widhe B. SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults-a study protocol for a prospective randomized double-blind multicenter clinical trial. Trials. 2021 Jun 22;22(1):411. doi: 10.1186/s13063-021-05366-7.
Reference Type
BACKGROUND
LaGuardia JS, Milek D, Lebens RS, Chen DR, Moghadam S, Loria A, Langstein HN, Fleming FJ, Leckenby JI. A Scoping Review of Quality-of-Life Assessments Employed in Abdominal Wall Reconstruction. J Surg Res. 2024 Mar;295:240-252. doi: 10.1016/j.jss.2023.10.013. Epub 2023 Dec 2.
Reference Type
BACKGROUND
Krpata DM, Schmotzer BJ, Flocke S, Jin J, Blatnik JA, Ermlich B, Novitsky YW, Rosen MJ. Design and initial implementation of HerQLes: a hernia-related quality-of-life survey to assess abdominal wall function. J Am Coll Surg. 2012 Nov;215(5):635-42. doi: 10.1016/j.jamcollsurg.2012.06.412. Epub 2012 Aug 4.
Reference Type
BACKGROUND
Koebe S, Greenberg J, Huang LC, Phillips S, Lidor A, Funk L, Shada A. Current practice patterns for initial umbilical hernia repair in the United States. Hernia. 2021 Jun;25(3):563-570. doi: 10.1007/s10029-020-02164-z. Epub 2020 Mar 11.
Reference Type
BACKGROUND
Kockerling F, Brunner W, Fortelny R, Mayer F, Adolf D, Niebuhr H, Lorenz R, Reinpold W, Zarras K, Weyhe D. Treatment of small (< 2 cm) umbilical hernias: guidelines and current trends from the Herniamed Registry. Hernia. 2021 Jun;25(3):605-617. doi: 10.1007/s10029-020-02345-w. Epub 2020 Nov 25.
Reference Type
BACKGROUND
Holihan JL, Flores-Gonzalez JR, Mo J, Ko TC, Kao LS, Liang MK. A Prospective Assessment of Clinical and Patient-Reported Outcomes of Initial Non-Operative Management of Ventral Hernias. World J Surg. 2017 May;41(5):1267-1273. doi: 10.1007/s00268-016-3859-5.
Reference Type
BACKGROUND
Dias Rasador AC, da Silveira CAB, Lima DL, Nogueira R, Malcher F, Sreeramoju P, Cavazzola LT. Mesh versus suture for elective primary umbilical hernia open repair: a systematic review and meta-analysis. Hernia. 2024 Dec;28(6):2069-2078. doi: 10.1007/s10029-024-03106-9. Epub 2024 Jul 13.
Reference Type
BACKGROUND
DeBord J, Novitsky Y, Fitzgibbons R, Miserez M, Montgomery A. SSI, SSO, SSE, SSOPI: the elusive language of complications in hernia surgery. Hernia. 2018 Oct;22(5):737-738. doi: 10.1007/s10029-018-1813-1. Epub 2018 Sep 10. No abstract available.
Reference Type
BACKGROUND
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Reference Type
BACKGROUND
Christoffersen MW, Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T. Long-term recurrence and chronic pain after repair for small umbilical or epigastric hernias: a regional cohort study. Am J Surg. 2015 Apr;209(4):725-32. doi: 10.1016/j.amjsurg.2014.05.021. Epub 2014 Jul 31.
Reference Type
BACKGROUND
Christoffersen MW, Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Lower reoperation rate for recurrence after mesh versus sutured elective repair in small umbilical and epigastric hernias. A nationwide register study. World J Surg. 2013 Nov;37(11):2548-52. doi: 10.1007/s00268-013-2160-0.
Reference Type
BACKGROUND
Bedewi MA, El-Sharkawy MS, Al Boukai AA, Al-Nakshabandi N. Prevalence of adult paraumbilical hernia. Assessment by high-resolution sonography: a hospital-based study. Hernia. 2012 Feb;16(1):59-62. doi: 10.1007/s10029-011-0863-4. Epub 2011 Jul 28.
Reference Type
BACKGROUND
Antonescu I, Scott S, Tran TT, Mayo NE, Feldman LS. Measuring postoperative recovery: what are clinically meaningful differences? Surgery. 2014 Aug;156(2):319-27. doi: 10.1016/j.surg.2014.03.005. Epub 2014 Mar 15.
Reference Type
BACKGROUND
Alvarez-Lozada LA, Arrambide-Garza FJ, Quiroga-Garza A, Huerta-Sanchez MC, Escobar-Luna A, Sada-Trevino MA, Ramos-Proano CE, Elizondo-Omana RE. Underdiagnosis of umbilical hernias in CT scans in a multicenter study - the radiologically neglected pathology and its surgical implications. Hernia. 2024 Oct;28(5):1775-1781. doi: 10.1007/s10029-024-03079-9. Epub 2024 Jun 5.
Reference Type
BACKGROUND
van Steensel S, van den Hil LCL, Bloemen A, Gijbels MJ, Breukink SO, Melenhorst J, Lenaerts K, Bouvy ND. Prevention of incisional hernia using different suture materials for closing the abdominal wall: a comparison of PDS, Vicryl and Prolene in a rat model. Hernia. 2020 Feb;24(1):67-78. doi: 10.1007/s10029-019-01941-9. Epub 2019 May 20.
Reference Type
BACKGROUND
Kaufmann R, Halm JA, Eker HH, Klitsie PJ, Nieuwenhuizen J, van Geldere D, Simons MP, van der Harst E, van 't Riet M, van der Holt B, Kleinrensink GJ, Jeekel J, Lange JF. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018 Mar 3;391(10123):860-869. doi: 10.1016/S0140-6736(18)30298-8. Epub 2018 Feb 17.
Reference Type
BACKGROUND
Henriksen NA, Montgomery A, Kaufmann R, Berrevoet F, East B, Fischer J, Hope W, Klassen D, Lorenz R, Renard Y, Garcia Urena MA, Simons MP; European and Americas Hernia Societies (EHS and AHS). Guidelines for treatment of umbilical and epigastric hernias from the European Hernia Society and Americas Hernia Society. Br J Surg. 2020 Feb;107(3):171-190. doi: 10.1002/bjs.11489. Epub 2020 Jan 9.
Reference Type
BACKGROUND
Haisley KR, Vadlamudi C, Gupta A, Collins CE, Renshaw SM, Poulose BK. Greatest Quality of Life Improvement in Patients With Large Ventral Hernias: An Individual Assessment of Items in the HerQLes Survey. J Surg Res. 2021 Dec;268:337-346. doi: 10.1016/j.jss.2021.06.075. Epub 2021 Aug 13.
Reference Type
BACKGROUND
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
Reference Type
BACKGROUND
Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
Reference Type
BACKGROUND
Bergstrom M, Widhe B, Granasen G, Lof Granstrom A, Ohlsson J, Schult S, Dahlstrand U, Osterberg J, Loogna P, Bringman S, Melkemichel M. Onlay mesh versus suture repair for smaller umbilical hernias in adults-early results from SUMMER trial: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae173. doi: 10.1093/bjsopen/zrae173.
Reference Type
BACKGROUND
Baucom RB, Ousley J, Oyefule OO, Stewart MK, Phillips SE, Browman KK, Sharp KW, Holzman MD, Poulose BK. Evaluation of long-term surgical site occurrences in ventral hernia repair: implications of preoperative site independent MRSA infection. Hernia. 2016 Oct;20(5):701-10. doi: 10.1007/s10029-016-1523-5. Epub 2016 Aug 8.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H24-03475
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Effect of Sutures Versus Mesh in Umbilical Hernia Repair
NCT01635868
COMPLETED
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
NCT05488288
RECRUITING
PHASE3
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
NCT00498810
TERMINATED
NA
Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial
NCT04231071
COMPLETED
NA
Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
NCT04311788
ACTIVE_NOT_RECRUITING
NA
NoPro - Norwegian Hernia Prophylaxis Study
NCT06858020
RECRUITING
NA
Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
NCT00970515
TERMINATED
NA
Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
NCT05201508
RECRUITING
NA
Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
NCT00786084
UNKNOWN
A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh
NCT00240188
COMPLETED
NA
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
NCT02053168
COMPLETED
NA
Phasix Mesh Use in Complex Open Ventral Hernias Study
NCT04580524
WITHDRAWN
NA
The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair
NCT01596049
TERMINATED
Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
NCT02542085
UNKNOWN
NA
Suture Techniques to Reduce the Incidence of The inCisional Hernia
NCT01132209
COMPLETED
NA
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
NCT01794338
TERMINATED
NA
Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial
NCT06066385
UNKNOWN
NA
Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy
NCT02208557
UNKNOWN
PHASE4
Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
NCT01201564
TERMINATED
PHASE4
Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
NCT01018524
COMPLETED
PHASE4
Veritas in Non-Bridging Ventral Hernia Repair
NCT01426477
TERMINATED
Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias
NCT01501682
UNKNOWN
Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias
NCT01639118
TERMINATED
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
NCT00773851
COMPLETED
NA