Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

Laparoscopic Colectomy Clinical Trial

Official title:

Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247389
• Other study ID #: 10-183-SDR
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Laparoscopic Colectomy

Intervention

Procedure:
• laparoscopic colectomy
Laparoscopic segmental colectomy with planned abdominal extraction site

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia		one year
Secondary	surgical site infection		one month
Secondary	body image		one year