Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
NCT ID: NCT02549456
Last Updated: 2017-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-12-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Natural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction
natural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
Laparoendoscopic resection
Laparoscopic assisted transanal endoscopic resection of rectal cancer
Laparoendoscopic resection
Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length.
Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed.
Interventions
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natural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
Laparoendoscopic resection
Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length.
Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed.
Eligibility Criteria
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Inclusion Criteria
2. Non metastatic pathologically proven sigmoid colon cancer.
3. Non metastatic pathologically proven rectal cancer.
4. Patient continent for stool.
Exclusion Criteria
2. Patients with cardiac or chest problems that cannot withstand insufflation.
3. Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
4. Obstructed or perforated cancer.
5. Patients with metastatic colorectal cancer.
6. Incontinent patients.
ALL
No
Sponsors
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Universidade da Coruña
OTHER
Mansoura University
OTHER
Responsible Party
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Islam Hany Metwally
Assistant lecturer of surgical oncology
Principal Investigators
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Jose F Noguira, MD
Role: STUDY_DIRECTOR
Head of general and digestive surgery department, CHUAC, universidade da Coruna
Sherif Z Kotb, MD
Role: STUDY_CHAIR
Professor of surgical oncology, Oncology center Mansoura University
Locations
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Oncology center Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MD/148
Identifier Type: -
Identifier Source: org_study_id
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