Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
September 26, 2014 updated by: Hiroki Yamaue
Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer.
A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery.
But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery.
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer.
A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.
The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Tumor size is less than 5cm
- No history of laparotomy
- No bowel obstruction by tumor
Exclusion Criteria:
- Patients who can't respond to medical question
- Patients who receive steroids or insulin therapy
- Uncontrolled DM
- Severe respiratory failure(HOT)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Midline incision
The extraction-site incision in laparoscopic colectomy is middline
|
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
|
|
Active Comparator: off-midline incision
The extraction-site incision in laparoscopic colectomy is off-middline
|
Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cosmetic effect
Time Frame: 1 year
|
Scar assessment score on the patient and observer scar assessment scale(POSAS)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: 7 days, 14 days and 30 days
|
Questionnaire on the SF-36 v2 acute
|
7 days, 14 days and 30 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incisional hernia
Time Frame: 1 year
|
Numbers of participants with incisional hernia
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: HIroki Yamaue, Chief prof., Second Department of Surgery, Wakayama Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.
- Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.
- Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
September 24, 2014
First Submitted That Met QC Criteria
September 26, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 26, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WMU1398
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.