Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial
NCT ID: NCT06066385
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
560 participants
INTERVENTIONAL
2023-08-01
2024-10-31
Brief Summary
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So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group.
Objective: The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.
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Detailed Description
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So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group.
Objective: The primary objective of this study study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.
Study design: Assessment of long-term follow-up (10-13 years) of a randomized controlled multicenter study based on retrospective review of patient files and relevant imaging of the entire trial population, as well as questionnaires and physical and radiological examination of patient who are still alive.
Study population: Of the 560 included patients in the original STITCH trial, 545 completed the 1-year follow-up.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: The primary outcome measure is the 10-year midline incisional hernia rate. The primary endpoint will be determined for the 545 patients of the original intention-to-treat population using Kaplan Meier analysis. In patients who died during follow-up, this will be evaluated by reviewing the available medical charts and radiological studies. CT-scans of the abdomen will be evaluated by the study-team. If CT imaging is not available, documented findings during physical examination by the relevant medical specialist will be considered. Patients being still alive with written informed consent to be contacted will be approached for their willingness to participate in this follow-up study, and after consent, we will reassess CT scans for an incisional hernia. All patients who are still alive and want to participate in this study will be asked to visit the hospital once for physical examination and an ultrasound of the abdominal wall.
Secondary outcome parameters include QoL and cosmetic outcome, Patients still alive with consent for participation will be sent the following questionnaires: MOS SF-36 and EQ-5D (QoL), Dresden Body Image Questionnaire (body image), Body Image Questionnaire (cosmesis), Hernia-Related Quality of Life Survey (abdominal wall function). Furthermore, readmission and surgical intervention rates related to midline IH will be determined for the entire study population.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Undergoing an ultrasound, physical examination and completing several questionnaires may be considered burdensome for the patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Small bites suturing technique of the abdominal wall during midline laparotomy
In the experimental group of 288 patients the small bites technique was applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.
Small bites technique
Closure of the fascia after midline laparotomy using a slowly resorbalbe 2.0 suture, with 0.5 cm bites, and 0.5 cm between the stitches, at least resulting in a 1:4 wound length:suture length ratio.
Large bites suturing technique of the abdominal wall during midline laparotomy
As control the conventional large bites technique (mass closure) was applied with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.
Conventional large bites closure
Closure of a midline laparotomy using a slowy resorbable thick suture (e.g. PDS loop) with large bites and large steps (\>= 1 cm).
Interventions
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Small bites technique
Closure of the fascia after midline laparotomy using a slowly resorbalbe 2.0 suture, with 0.5 cm bites, and 0.5 cm between the stitches, at least resulting in a 1:4 wound length:suture length ratio.
Conventional large bites closure
Closure of a midline laparotomy using a slowy resorbable thick suture (e.g. PDS loop) with large bites and large steps (\>= 1 cm).
Eligibility Criteria
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Inclusion Criteria
* Or if the patients has died, the medical records are reviewed.
A potential subject who meets the following criteria will be excluded from participation in this study:
\- Patients that on the original informed consent form of the STITCH trial, checked the box that they did not want to be approached for future follow-up studies.
18 Years
110 Years
ALL
No
Sponsors
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Franciscus &Vlietland
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Rijnstate Hospital
OTHER
Spaarne Gasthuis
OTHER
Meander Medisch Centrum
OTHER
Red Cross Hospital Beverwijk
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Prof. dr. Pieter J Tanis
Prof.dr. P.J. Tanis
Principal Investigators
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Pieter J Tanis
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus MC
Rotterdam, South Holland, Netherlands
Meander Medical Center
Amersfoort, , Netherlands
Rijnstate ziekenhuis
Arnhem, , Netherlands
Red Cross Hospital
Beverwijk, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, , Netherlands
Prior Havenziekenhuis patients currently in the Erasmus MC
Rotterdam, , Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Related Links
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Original STITCH trial
Other Identifiers
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IIS WC-2022-06
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MEC 2022-0652
Identifier Type: REGISTRY
Identifier Source: secondary_id
9354
Identifier Type: -
Identifier Source: org_study_id
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