Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair
NCT ID: NCT04838028
Last Updated: 2025-07-01
Study Results
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Basic Information
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COMPLETED
15360 participants
OBSERVATIONAL
2012-09-01
2020-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard polypropylene mesh
Density \> 50 g/square meter
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Lightweight mesh
* A mesh based on either polypropylene or polyester. Some variants contain purely 1 polymer. Others are composite, ie, contain also an absorbable material.
* The density \< 50 g/square meter (when applicable, after partial absorption).
* In this study, the property of light weight will trump the material, ie, any lightweight mesh having been registered as, eg, "Polyester mesh", will be reclassified as "Lightweight mesh".
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Fixation with metal tacks
Non-absorbable metal staples or tacks
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Fixation with absorbable tacks
Absorbable synthetic staples or tacks
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Fibrin glue fixation
Biologic glue/sealant produced from human donor blood
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Non-fixation
Mesh is deployed without fixation
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
3D mesh
A polypropylene mesh with a preformed anatomic shape corresponding to the inner preperitoneal curvature of the groin.
The category does not differentiate between standard and lightweight variants.
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Progrip fixation
Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark.
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Polyester mesh
Polyester-based mesh. This category does not differentiate between standard and lightweight variants. If a mesh was initially registered under this category by the surgeon, but identified being a lightweight mesh by the researchers, it will be re-classified as "Lightweight mesh".
TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Interventions
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TEP
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPP
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repair
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hernioplasties that were converted from laparoscopic to open surgery.
* Bilateral repairs.
* Surgery merely for hernia (eg obturator) other than lateral, medial or femoral.
* Age \< 15 years.
* Patients not having a 10-digit state-assigned Patient Identification Number.
15 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Swedish Hernia Registry
UNKNOWN
Karolinska Institutet
OTHER
Responsible Party
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Bengt Novik
MD, PhD, SSOD
Principal Investigators
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Bengt Novik, MD
Role: PRINCIPAL_INVESTIGATOR
Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
References
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Novik B, Nordin P, Skullman S, Dalenback J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011 Jan;146(1):12-7. doi: 10.1001/archsurg.2010.302.
Novik B, Hagedorn S, Mork UB, Dahlin K, Skullman S, Dalenback J. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period. Surg Endosc. 2006 Mar;20(3):462-7. doi: 10.1007/s00464-005-0391-3. Epub 2006 Jan 19.
Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.
Olsson A, Sandblom G, Franneby U, Sonden A, Gunnarsson U, Dahlstrand U. The Short-Form Inguinal Pain Questionnaire (sf-IPQ): An Instrument for Rating Groin Pain After Inguinal Hernia Surgery in Daily Clinical Practice. World J Surg. 2019 Mar;43(3):806-811. doi: 10.1007/s00268-018-4863-8.
Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.
Other Identifiers
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Bengan IV
Identifier Type: -
Identifier Source: org_study_id
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