NCT03001375

Brief 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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

4.5 years

First QC Date

December 9, 2016

Last Update Submit

December 20, 2016

Conditions

Splenic Flexure Mobilization

Keywords

Laparoscopic colectomy.Splenic flexure mobilization.Anastomotic leakage.

Outcome Measures

Primary Outcomes (1)

  • the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure

    One year

Study Arms (2)

Mobilization group

ACTIVE COMPARATOR

Laparoscopic splenic flexure mobilization will be done.

Procedure: Laparoscopic high anterior resection splenic flexure mobilization

Non mobilization group

ACTIVE COMPARATOR

No mobilization of splenic flexure.

Procedure: Laparoscopic high anterior resection without splenic flexure mobilization

Interventions

Laparoscopic high anterior resection splenic flexure mobilizationPROCEDURE
Mobilization group
Laparoscopic high anterior resection without splenic flexure mobilizationPROCEDURE
Non mobilization group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with upper rectal tumors.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 23, 2016

Study Start

May 1, 2011

Primary Completion

November 1, 2015

Study Completion

December 1, 2016

Last Updated

December 23, 2016

Record last verified: 2016-12