Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Laparoscopic Colectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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midline incision

Group Type ACTIVE_COMPARATOR

laparoscopic colectomy

Intervention Type PROCEDURE

Laparoscopic segmental colectomy with planned abdominal extraction site

transverse incision

Group Type ACTIVE_COMPARATOR

laparoscopic colectomy

Intervention Type PROCEDURE

Laparoscopic segmental colectomy with planned abdominal extraction site

Interventions

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laparoscopic colectomy

Laparoscopic segmental colectomy with planned abdominal extraction site

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No