Laparoscopic Splenic Flexure Mobilization

December 20, 2016 updated by: Yasser Mohamed Abdel-samii, Ain Shams University

Is it Necessary to do Splenic Flexure Mobilization in Laparoscopic Resection of Upper Rectal Tumors?

This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior resection for upper rectal cancer in the period from May 2011 to November 2015, comparison will be done on splenic flexure mobilization excluding .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Presently, it is acknowledged that laparoscopic colectomy for left sided colorectal cancer is the most common surgery operated in laparoscopic colorectal surgeries, However the most debatable question in such type of operations that is it mandatory to do splenic flexure mobilization or not? In the literatures colorectal surgeons divided into 2 teams, those with splenic flexure mobilization in laparoscopic left colorectal resection to have tension free, well vascularized anastomosis On the other hand those against splenic flexure mobilization reported that omitting this step does not significantly affect the leakage rate, morbidity or the oncological outcomes In this study, we evaluate the necessity of splenic flexure mobilization in laparoscopic anterior resection for upper rectal tumors and its impact on the operative time, total morbidity, leakage rate, oncological safety and continence level

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with upper rectal tumors.

Exclusion Criteria:

  • Low and mid rectal cancer
  • Splenic flexure tumors, descending colon cancer,
  • patients with associated lesions in the right or transverse colon
  • Emergency cases.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mobilization group
Laparoscopic splenic flexure mobilization will be done.
Procedure: Laparoscopic high anterior resection splenic flexure mobilization
Active Comparator: Non mobilization group
No mobilization of splenic flexure.
Procedure: Laparoscopic high anterior resection without splenic flexure mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

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

May 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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