NCT01247389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

5.4 years

First QC Date

November 23, 2010

Last Update Submit

August 14, 2018

Conditions

Laparoscopic Colectomy

Keywords

laparoscopycolon resectionincisional hernia

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia

    one year

Secondary Outcomes (2)

  • surgical site infection

    one month

  • body image

    one year

Study Arms (2)

midline incision

ACTIVE COMPARATOR
Procedure: laparoscopic colectomy

transverse incision

ACTIVE COMPARATOR
Procedure: laparoscopic colectomy

Interventions

laparoscopic colectomyPROCEDURE

Laparoscopic segmental colectomy with planned abdominal extraction site

midline incisiontransverse incision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled laparoscopic partial colectomy where an abdominal extraction incision is planned

You may not qualify if:

  • previous laparotomy
  • rectal resection or anastamosis
  • planned pfannenstiel extraction incision
  • single site surgery
  • planned or performed stoma
  • BMI \>35 kg/m2
  • ASA 4-5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

July 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

CA(1)