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Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

This study is currently recruiting participants.
Verified September 2016 by Dr. Liane S. Feldman, McGill University Health Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247389
First Posted: November 24, 2010
Last Update Posted: September 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Center
  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 (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 Dr. Liane S. Feldman, McGill University Health Center:

Primary Outcome Measures:
  • Incisional hernia [ Time Frame: one year ]

Secondary Outcome Measures:
  • surgical site infection [ Time Frame: one month ]
  • body image [ Time Frame: one year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 23, 2010
First Posted: November 24, 2010
Last Update Posted: September 19, 2016
Last Verified: September 2016

Keywords provided by Dr. Liane S. Feldman, McGill University Health Center:
laparoscopy
colon resection
incisional hernia

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