Laparoscopic, Total Mesorectal Excision
Conditions
Keywords
LE-TME, Laparoscopic rectal resection, Retroperitoneal resection
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.
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.
Interventions
PROCEDURELE-TME
Retroperitoneal approach for total mesorectal excision
Sponsors
West oncologic center, Nantes, France
Gustave Roussy, Cancer Campus, Grand Paris
Mansoura University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the procedure | 1 day | Feasibility of the TME by the retroperitoneal approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative morbidity | 1 day | Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury. |
| Postoperative morbidity | Till patient discharge | Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction |
| Pathologic report outcome | 7 days | Lymph node harvest, radial and circumferential margin, complete total mesorectal excison |
Countries
Egypt
Outcome results
None listed