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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001375
Other study ID # 6379
Secondary ID
Status Completed
Phase N/A
First received December 9, 2016
Last updated December 20, 2016
Start date May 2011
Est. completion date December 2016

Study information

Verified date December 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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 .


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


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic high anterior resection splenic flexure mobilization

Laparoscopic high anterior resection without splenic flexure mobilization


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure One year Yes