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
Other: midline incision or off-midline incision
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
Other: midline incision or off-midline incision
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

Hiroki Yamaue

Collaborators

Katsunari Takifuji

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

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.

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