MedTrace Logo

Hernia After Colorectal Cancer Surgery

NCT03390764 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2022-09-09

No results posted yet for this study

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

Interventions

PROCEDURE

4:1 closure group

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

PROCEDURE

RTL plus 4:1 closure group

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

Sponsors & Collaborators

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Ulf Petersson, MD, Ass Prof · Department of Surgery, Skane University Hospital, Malmö Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2022-05-20
Completion
2024-05-20

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390764 on ClinicalTrials.gov