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

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ClinicalTrials.gov Identifier: NCT02455752
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : July 17, 2015
Sponsor:
Collaborators:
West oncologic center, Nantes, France
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Osama Mohammad Ali ElDamshety, 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.

Condition or disease Intervention/treatment Phase
Total Mesorectal Excision Laparoscopic Procedure: LE-TME Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

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



Primary Outcome Measures :
  1. Feasibility of the procedure [ Time Frame: 1 day ]
    Feasibility of the TME by the retroperitoneal approach.


Secondary Outcome Measures :
  1. Intraoperative morbidity [ Time Frame: 1 day ]
    Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury.

  2. Postoperative morbidity [ Time Frame: Till patient discharge ]
    Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction

  3. Pathologic report outcome [ Time Frame: 7 days ]
    Lymph node harvest, radial and circumferential margin, complete total mesorectal excison



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455752


Locations
Egypt
Oncology center of mansoura university
Mansoura, Eldakahlia, Egypt, 35511
Sponsors and Collaborators
Mansoura University
West oncologic center, Nantes, France
Gustave Roussy, Cancer Campus, Grand Paris
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

Responsible Party: Osama Mohammad Ali ElDamshety, Assisstant Lecturer of surgical oncology, Mansoura University
ClinicalTrials.gov Identifier: NCT02455752     History of Changes
Other Study ID Numbers: RTME-200315
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by Osama Mohammad Ali ElDamshety, Mansoura University:
LE-TME
Laparoscopic rectal resection
Retroperitoneal resection