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

Not Applicable

Completed

• Conditions: Total Mesorectal Excision; Laparoscopic
• Interventions: Procedure: LE-TME

• Registration Number: NCT02455752
• Lead Sponsor: Mansoura University

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-28
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reroperitoneal Group	LE-TME	LE-TME

Primary Outcome Measures

Name	Time	Method
Feasibility of the procedure	1 day	Feasibility of the TME by the retroperitoneal approach.

Secondary Outcome Measures

Name	Time	Method
Pathologic report outcome	7 days	Lymph node harvest, radial and circumferential margin, complete total mesorectal excison
Intraoperative morbidity	1 day	Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury.
Postoperative morbidity	Till patient discharge	Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction

Trial Locations

Locations (1)

Oncology center of mansoura university; 🇪🇬 Mansoura, Eldakahlia, Egypt