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CompletedNCT01247389Updated Aug 15, 2018

Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

An interventional study of laparoscopic colectomy in Laparoscopic Colectomy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Laparoscopic Colectomy

Keywords

  • laparoscopy
  • colon resection
  • incisional hernia
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 165 is above the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Active comparator
    midline incision

    Procedure: laparoscopic colectomy

  • Active comparator
    transverse incision

    Procedure: laparoscopic colectomy

Interventions

  • Procedurelaparoscopic colectomy

    Laparoscopic segmental colectomy with planned abdominal extraction site

06

What researchers measure

Primary outcomes

  1. Incisional hernia

    Time frame: one year

Secondary outcomes

  1. surgical site infection

    Time frame: one month

  2. body image

    Time frame: one year

07

Study locations

1 site
  • Montreal General Hospital
    Montreal, Quebec H3G 1A4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01247389
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Dr. Liane S. Feldman (MD, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Nov 24, 2010
Start date
Jul 2011
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Aug 15, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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