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| Name | Class |
|---|---|
| West oncologic center, Nantes, France | UNKNOWN |
| Gustave Roussy, Cancer Campus, Grand Paris | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reroperitoneal Group | Active Comparator | LE-TME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LE-TME | Procedure | Retroperitoneal approach for total mesorectal excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the procedure | Feasibility of the TME by the retroperitoneal approach. | 1 day |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology center of mansoura university | Al Mansurah | Eldakahlia | 35511 | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 17, 2015 | |
| Unrelease | Yes | |
| Release | Jul 24, 2015 | |
| Unrelease | Yes | |
| Release | Jul 26, 2015 | |
| Unrelease | Yes | |
| Release | Jul 28, 2015 | |
| Unrelease | Yes | |
| Release | Jul 29, 2015 | |
| Unrelease | Yes | |
| Release | Jul 30, 2015 | |
| Unrelease | Yes | |
| Release | Sep 20, 2018 | |
| Reset | Feb 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 17, 2015 | Yes | |||
| Jul 24, 2015 |
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| Till patient discharge |
| Pathologic report outcome | Lymph node harvest, radial and circumferential margin, complete total mesorectal excison | 7 days |
| Yes |
| Jul 26, 2015 | Yes |
| Jul 28, 2015 | Yes |
| Jul 29, 2015 | Yes |
| Jul 30, 2015 | Yes |
| Sep 20, 2018 | Feb 8, 2019 |