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

Laparoscopic Clinical Trial

— LE-TME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455752
• Other study ID #: RTME-200315
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: July 16, 2015
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic
• Total Mesorectal Excision

Intervention

Procedure:
• LE-TME
Retroperitoneal approach for total mesorectal excision

Locations

Country	Name	City	State
Egypt	Oncology center of mansoura university	Mansoura	Eldakahlia

Sponsors (3)

Lead Sponsor	Collaborator
Mansoura University	Gustave Roussy, Cancer Campus, Grand Paris, West oncologic center, Nantes, France

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the procedure	Feasibility of the TME by the retroperitoneal approach.	1 day	No
Secondary	Intraoperative morbidity	Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury.	1 day	Yes
Secondary	Postoperative morbidity	Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction	Till patient discharge	Yes
Secondary	Pathologic report outcome	Lymph node harvest, radial and circumferential margin, complete total mesorectal excison	7 days	Yes