Hernia After Colorectal Cancer Surgery

NCT03390764 | Unknown

• 1 other identifier: SkaneU
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Incisional Hernia; Wound Dehiscence; Wound Complication; Quality of Life

Keywords

Incisional hernia; 4:1-technique; RTL-suture

Outcome Measures

Primary Outcomes (1)

• Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture

  Evaluated by clinical investigation and CT-scan

  One year

Secondary Outcomes (4)

• Wound dehiscence and other wound complications

  One month or longer

• Incisional hernia after 3 years

  3 years

• Abdominal wall discomfort at 1- and 3 years follow-up

  1 and 3 years

• Quality of life after 1- and 3 years

  1 and 3 years

Study Arms (2)

4:1 closure group

ACTIVE COMPARATOR

Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall.

Procedure: 4:1 closure group

RTL plus 4:1 closure group

ACTIVE COMPARATOR

Patients randomized to and receiving the intervention reinforced tension-line suture plus small stitch 4:1 technique for closure of the abdominal wall.

Procedure: RTL plus 4:1 closure group

Interventions

4:1 closure group PROCEDURE

In this arm the incisions are closed by the 4:1-technique

4:1 closure group

RTL plus 4:1 closure group PROCEDURE

In this arm the incisions are closed by a reinforced tension-line suture in addition to the 4:1-technique

RTL plus 4:1 closure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years planned for colorectal cancer surgery through a midline incision

You may not qualify if:

• 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

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Department of surgery, Skane university hospital

Malmo, SE 205 02, Sweden

Location

Related Publications (6)

• Bosanquet 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 BACKGROUND

• Muysoms 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 BACKGROUND

• Hollinsky 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 BACKGROUND

• Agarwal 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 BACKGROUND

• Millbourn 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 BACKGROUND

• Wenzelberg 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 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Ulf Petersson, MD, Ass Prof

  Department of Surgery, Skane University Hospital, Malmö Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Ass Prof

Model Details: Multicenter randomized controlled trial

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: October 16, 2017
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2024
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

SE (1)