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Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01247389
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE November 23, 2010
First Posted Date  ICMJE November 24, 2010
Last Update Posted Date August 15, 2018
Study Start Date  ICMJE July 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
Incisional hernia [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
  • surgical site infection [ Time Frame: one month ]
  • body image [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy
Official Title  ICMJE Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Colectomy
Intervention  ICMJE Procedure: laparoscopic colectomy
Laparoscopic segmental colectomy with planned abdominal extraction site
Study Arms  ICMJE
  • Active Comparator: midline incision
    Intervention: Procedure: laparoscopic colectomy
  • Active Comparator: transverse incision
    Intervention: Procedure: laparoscopic colectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2018)
165
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2010)
50
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01247389
Other Study ID Numbers  ICMJE 10-183-SDR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP