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Clinical Trials/NCT02455752
NCT02455752
Completed
Not Applicable

Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

Mansoura University1 site in 1 country5 target enrollmentStarted: March 2015Last updated:
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ConditionsTotal Mesorectal ExcisionLaparoscopic

Overview

Phase
Not Applicable
Status
Completed
Enrollment
5
Locations
1
Primary Endpoint
Feasibility of the procedure
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The study involves the use of Retroperitoneal plane for TME for rectal anterior resection. Through a pilot prospective study, LR-TME will be assessed as one arm study.

Detailed Description

This study is based on our new suggested theory for a retro-peritoneal approach. After successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the feasibilty of the new approach.

Data will be registered prospectively and the perioperative outcomes will be assessed.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •(Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery

Exclusion Criteria

  • •contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.

Outcomes

Primary Outcomes

Feasibility of the procedure

Time Frame: 1 day

Feasibility of the TME by the retroperitoneal approach.

Secondary Outcomes

  • Intraoperative morbidity(1 day)
  • Postoperative morbidity(Till patient discharge)
  • Pathologic report outcome(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Osama Mohammad Ali ElDamshety

Assisstant Lecturer of surgical oncology

Mansoura University

Study Sites (1)

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