Clinical trial · Interventional
Hernia After Colorectal Cancer Surgery
Rein4CeTo1: Incisional Hernia After Colorectal Cancer Surgery - a Randomized Controlled Multicentre Trial Comparing Small Stitch 4:1-technique With Respectively Without a Reinforced Tension-line Suture for Abdominal Closure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Defects in the abdominal wall (incisional hernia) is a frequent negative outcome after surgery. Reinforcing the incision with mesh seem to lower the incidence but in surgery that includes bowel resection a simple alternative, cheaper and less prone to infection than a synthetic mesh, would be of interest. The primary aim of this multicentre randomized controlled trial is to compare the incisional hernia incidence one year after planned colorectal cancer surgery performed through a midline incision which is closed either by a standardized small stitch 4:1 technique (the incision is closed with the use of suture of 4 times the length of the incision) or with the same technique plus a reinforced tension-line suture (a suture is applied in the fibrous tissue parallel to the incision which is then embraced by the 4:1 suture when the incision is closed). A difference in incisional hernia of 15% (20% without and 5% with reinforced tension-line suture) is assumed. Secondary aims are to evaluate incidences of wound dehiscence, other wound complications and incisional hernia after 3 years. Furthermore we aim to evaluate patient satisfaction and quality of life.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Incisional Hernia | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
| Wound Dehiscence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4:1 closure group | Procedure | — | UNRESOLVED |
| RTL plus 4:1 closure group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 4:1 closure group
- description
- Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall.
- interventionNames
- Procedure: 4:1 closure group
- type
- ACTIVE_COMPARATOR
- label
- RTL plus 4:1 closure group
- description
- Patients randomized to and receiving the intervention reinforced tension-line suture plus small stitch 4:1 technique for closure of the abdominal wall.
- interventionNames
- Procedure: RTL plus 4:1 closure group
Primary outcomes (1)
- measure
- Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: • Patients ≥ 18 years planned for colorectal cancer surgery through a midline incision Exclusion Criteria: * Former incisional hernia surgery in the midline * Present incisional hernia in the midline * ASA\>3 * Peritoneal carcinomatosis eligible for peritonealectomy/HIPEC * Patient not able to participate in follow-up * Patient not willing to take part in the study
References
Publications (6)
- BACKGROUNDBosanquet DC, Ansell J, Abdelrahman T, Cornish J, Harries R, Stimpson A, Davies L, Glasbey JC, Frewer KA, Frewer NC, Russell D, Russell I, Torkington J. Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS One. 2015 Sep 21;10(9):e0138745. doi: 10.1371/journal.pone.0138745. eCollection 2015. PMID 26389785
- BACKGROUNDMuysoms FE, Dietz UA. Prophylactic meshes in the abdominal wall. Chirurg. 2017 Jan;88(Suppl 1):34-41. doi: 10.1007/s00104-016-0229-7. PMID 27460229
- BACKGROUNDHollinsky C, Sandberg S, Kocijan R. Preliminary results with the reinforced tension line: a new technique for patients with ventral abdominal wall hernias. Am J Surg. 2007 Aug;194(2):234-9. doi: 10.1016/j.amjsurg.2006.09.045. PMID 17618812
- BACKGROUNDAgarwal A, Hossain Z, Agarwal A, Das A, Chakraborty S, Mitra N, Gupta M, Ray U. Reinforced tension line suture closure after midline laparotomy in emergency surgery. Trop Doct. 2011 Oct;41(4):193-6. doi: 10.1258/td.2011.110045. Epub 2011 Aug 10. PMID 21831931
- BACKGROUNDMillbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189. PMID 19917943
- DERIVEDWenzelberg CL, Rogmark P, Ekberg O, Petersson U. Reinforced tension-line suture after laparotomy: early results of the Rein4CeTo1 randomized clinical trial. Br J Surg. 2024 Sep 3;111(10):znae265. doi: 10.1093/bjs/znae265. PMID 39475416