Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

This study is currently recruiting participants.

Verified April 2012 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: April 19, 2012

Last verified: April 2012

History of Changes

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:

MedlinePlus related topics: Hernia

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	June 2013 (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
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

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

No publications provided

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:	April 19, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

laparoscopy
colon resection
incisional hernia

Additional relevant MeSH terms:

Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013

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