Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer (NOTES)
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|ClinicalTrials.gov Identifier: NCT02549456|
Recruitment Status : Unknown
Verified March 2017 by Islam Hany Metwally, Mansoura University.
Recruitment status was: Recruiting
First Posted : September 15, 2015
Last Update Posted : March 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: natural orifice specimen extraction Procedure: Laparoendoscopic resection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||February 2018|
Experimental: Natural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction
Procedure: natural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
Experimental: Laparoendoscopic resection
Laparoscopic assisted transanal endoscopic resection of rectal cancer
Procedure: 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.
- Feasibility [ Time Frame: 24 hour ]Rate of conversion to classic laparoscopy or to open laparotomy.
- operative time [ Time Frame: 24 hour ]time taken from starting operation till patient wake up
- Operative blood loss [ Time Frame: 24 hour ]measured in milliliter
- Wound complications [ Time Frame: two week ]infection-dehiscence
- Major intraoperative complications [ Time Frame: 24 hour ]bleeding -organ injury
- Major postoperative complications [ Time Frame: two weeks ]leak-bleeding
- Adequacy of lymphadenectomy [ Time Frame: one month ]Number of lymph nodes retrieved
- Grading of quality and completeness of mesorectal excision [ Time Frame: one month ]It is a composite outcome where result will appear as either complete, near complete or incomplete. Criteria in (shape, coning, presence of defects and circumferential safety margin) will be integrated to categorize it.
- Longitudinal safety margin [ Time Frame: one month ]either free or infiltrated with tumor by histopathology examination.
- short term oncologic outcome [ Time Frame: 6 months - one year ]incidence of local and distant outcomes and disease free survival
- Functional outcome [ Time Frame: 3 months ]assessing fecal incontinence using Kirwan's grading score
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): NCT02549456
|Contact: Islam H Metwally, M.Sc||01002985865 ext firstname.lastname@example.org|
|Oncology center Mansoura University||Recruiting|
|Mansoura, Dakahlia, Egypt, 35516|
|Contact: Islam H Metwally, M.Sc 01002985865 ext 02 email@example.com|
|Sub-Investigator: Mohamed A Hegazy, MD|
|Sub-Investigator: Waleed E Rashad, MD|
|Study Director:||Jose F Noguira, MD||Head of general and digestive surgery department, CHUAC, universidade da Coruna|
|Study Chair:||Sherif Z Kotb, MD||Professor of surgical oncology, Oncology center Mansoura University|