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Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

Primary Purpose

Laparoscopic Colectomy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
laparoscopic colectomy
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Colectomy focused on measuring laparoscopy, colon resection, incisional hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

midline incision

transverse incision

Arm Description

Outcomes

Primary Outcome Measures

Incisional hernia

Secondary Outcome Measures

surgical site infection
body image

Full Information

First Posted
November 23, 2010
Last Updated
August 14, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01247389
Brief Title
Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy
Official Title
Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Colectomy
Keywords
laparoscopy, colon resection, incisional hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
midline incision
Arm Type
Active Comparator
Arm Title
transverse incision
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopic colectomy
Intervention Description
Laparoscopic segmental colectomy with planned abdominal extraction site
Primary Outcome Measure Information:
Title
Incisional hernia
Time Frame
one year
Secondary Outcome Measure Information:
Title
surgical site infection
Time Frame
one month
Title
body image
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

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