Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01247389
First received: November 23, 2010
Last updated: September 26, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Laparoscopic Colectomy
Procedure: laparoscopic colectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Incisional hernia [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • surgical site infection [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • body image [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247389

Contacts
Contact: Liane S Feldman, MD 514 934 1934 ext 44337 liane.feldman@mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Liane Feldman, MD    514 934-1934 ext 44004    liane.feldman@mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
  More Information

Responsible Party: Dr. Liane S. Feldman, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01247389     History of Changes
Other Study ID Numbers: 10-183-SDR 
Study First Received: November 23, 2010
Last Updated: September 26, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
laparoscopy
colon resection
incisional hernia

Additional relevant MeSH terms:
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2016