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

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.

Study Overview

• Status: Completed
• Conditions: Total Mesorectal Excision; Laparoscopic
• Intervention / Treatment: Procedure: LE-TME

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Eldakahlia
    • Mansoura, Eldakahlia, Egypt, 35511
      • Oncology Center of Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reroperitoneal Group; LE-TME	Procedure: LE-TME; Retroperitoneal approach for total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the procedure	Feasibility of the TME by the retroperitoneal approach.	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Gustave Roussy, Cancer Campus, Grand Paris; West oncologic center, Nantes, France
• Investigators: Principal Investigator: Osama Eldamshety, PhD, 1-Assistant lecturer of surgical oncology, Mansoura university Egypt. 2-Research Fellow, Policlinico Umberto primo, LA SAPIENZA, Roma, Italy.; Principal Investigator: Frédéric Dumont, M.D., 1- Department of Digestive Oncological surgery, West oncologic center, Nantes, France 2- Department of digestive Oncological surgery, Gustave Roussy Cancer Campus, Villejuif, France

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: LE-TME; Laparoscopic rectal resection; Retroperitoneal resection
• Other Study ID Numbers: RTME-200315