Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer (NOTES)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
natural orifice specimen extraction
Laparoendoscopic resection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring natural orifice surgery, natural orifice specimen extraction, taTME
Eligibility Criteria
Inclusion Criteria:
- Medically fit patient.
- Non metastatic pathologically proven sigmoid colon cancer.
- Non metastatic pathologically proven rectal cancer.
- Patient continent for stool.
Exclusion Criteria:
- Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
- Patients with cardiac or chest problems that cannot withstand insufflation.
- 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).
- Obstructed or perforated cancer.
- Patients with metastatic colorectal cancer.
- Incontinent patients.
Sites / Locations
- Oncology center Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Natural orifice specimen extraction
Laparoendoscopic resection
Arm Description
Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction
Laparoscopic assisted transanal endoscopic resection of rectal cancer
Outcomes
Primary Outcome Measures
Feasibility
Rate of conversion to classic laparoscopy or to open laparotomy.
operative time
time taken from starting operation till patient wake up
Operative blood loss
measured in milliliter
Wound complications
infection-dehiscence
Major intraoperative complications
bleeding -organ injury
Major postoperative complications
leak-bleeding
Secondary Outcome Measures
Adequacy of lymphadenectomy
Number of lymph nodes retrieved
Grading of quality and completeness of mesorectal excision
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
either free or infiltrated with tumor by histopathology examination.
short term oncologic outcome
incidence of local and distant outcomes and disease free survival
Functional outcome
assessing fecal incontinence using Kirwan's grading score
Full Information
NCT ID
NCT02549456
First Posted
August 29, 2015
Last Updated
March 22, 2017
Sponsor
Mansoura University
Collaborators
Universidade da Coruña
1. Study Identification
Unique Protocol Identification Number
NCT02549456
Brief Title
Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
Acronym
NOTES
Official Title
Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
Universidade da Coruña
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.
Detailed Description
Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
natural orifice surgery, natural orifice specimen extraction, taTME
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Natural orifice specimen extraction
Arm Type
Experimental
Arm Description
Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction
Arm Title
Laparoendoscopic resection
Arm Type
Experimental
Arm Description
Laparoscopic assisted transanal endoscopic resection of rectal cancer
Intervention Type
Procedure
Intervention Name(s)
natural orifice specimen extraction
Intervention Description
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
Intervention Type
Procedure
Intervention Name(s)
Laparoendoscopic resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Description
Rate of conversion to classic laparoscopy or to open laparotomy.
Time Frame
24 hour
Title
operative time
Description
time taken from starting operation till patient wake up
Time Frame
24 hour
Title
Operative blood loss
Description
measured in milliliter
Time Frame
24 hour
Title
Wound complications
Description
infection-dehiscence
Time Frame
two week
Title
Major intraoperative complications
Description
bleeding -organ injury
Time Frame
24 hour
Title
Major postoperative complications
Description
leak-bleeding
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Adequacy of lymphadenectomy
Description
Number of lymph nodes retrieved
Time Frame
one month
Title
Grading of quality and completeness of mesorectal excision
Description
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.
Time Frame
one month
Title
Longitudinal safety margin
Description
either free or infiltrated with tumor by histopathology examination.
Time Frame
one month
Title
short term oncologic outcome
Description
incidence of local and distant outcomes and disease free survival
Time Frame
6 months - one year
Title
Functional outcome
Description
assessing fecal incontinence using Kirwan's grading score
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medically fit patient.
Non metastatic pathologically proven sigmoid colon cancer.
Non metastatic pathologically proven rectal cancer.
Patient continent for stool.
Exclusion Criteria:
Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
Patients with cardiac or chest problems that cannot withstand insufflation.
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).
Obstructed or perforated cancer.
Patients with metastatic colorectal cancer.
Incontinent patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam H Metwally, M.Sc
Phone
01002985865
Ext
02
Email
dr.islamo@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose F Noguira, MD
Organizational Affiliation
Head of general and digestive surgery department, CHUAC, universidade da Coruna
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherif Z Kotb, MD
Organizational Affiliation
Professor of surgical oncology, Oncology center Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Oncology center Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam H Metwally, M.Sc
Phone
01002985865
Ext
02
Email
drislamhany@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed A Hegazy, MD
First Name & Middle Initial & Last Name & Degree
Waleed E Rashad, MD
12. IPD Sharing Statement
Learn more about this trial
Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
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