Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

August 14, 2018 updated by: Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre

Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial

Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that laparoscopic colon resection would result in fewer incisional hernias, prospective studies demonstrate a similar incidence to open surgery. Observational studies suggest that the rate of incisional hernia after laparoscopic colon resection may be reduced with the use of a transverse compared to a midline extraction incision. However, no randomized trails are available, and a midline extraction incision for hemicolectomy remains the standard current approach. The investigators hypothesize that the use of a lower abdominal transverse muscle splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer incisional hernias compared to a midline periumbilical extraction incision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled laparoscopic partial colectomy where an abdominal extraction incision is planned

Exclusion Criteria:

  • previous laparotomy
  • rectal resection or anastamosis
  • planned pfannenstiel extraction incision
  • single site surgery
  • planned or performed stoma
  • BMI >35 kg/m2
  • ASA 4-5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: midline incision
Procedure: laparoscopic colectomy
Laparoscopic segmental colectomy with planned abdominal extraction site
Active Comparator: transverse incision
Procedure: laparoscopic colectomy
Laparoscopic segmental colectomy with planned abdominal extraction site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incisional hernia
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
surgical site infection
Time Frame: one month
one month
body image
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-183-SDR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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