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
|Condition or disease||Intervention/treatment||Phase|
|Total Mesorectal Excision Laparoscopic||Procedure: LE-TME||Not Applicable|
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)|
|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|
Active Comparator: Reroperitoneal Group
Retroperitoneal approach for total mesorectal excision
- Feasibility of the procedure [ Time Frame: 1 day ]Feasibility of the TME by the retroperitoneal approach.
- Intraoperative morbidity [ Time Frame: 1 day ]Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury.
- Postoperative morbidity [ Time Frame: Till patient discharge ]Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction
- Pathologic report outcome [ Time Frame: 7 days ]Lymph node harvest, radial and circumferential margin, complete total mesorectal excison
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
|Oncology center of mansoura university|
|Mansoura, Eldakahlia, Egypt, 35511|
|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|