Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer (NOTES)

March 22, 2017 updated by: Islam Hany Metwally, Mansoura University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Oncology center Mansoura University
        • Contact:
        • Sub-Investigator:
          • Mohamed A Hegazy, MD
        • Sub-Investigator:
          • Waleed E Rashad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medically fit patient.
  2. Non metastatic pathologically proven sigmoid colon cancer.
  3. Non metastatic pathologically proven rectal cancer.
  4. Patient continent for stool.

Exclusion Criteria:

  1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 24 hour
Rate of conversion to classic laparoscopy or to open laparotomy.
24 hour
operative time
Time Frame: 24 hour
time taken from starting operation till patient wake up
24 hour
Operative blood loss
Time Frame: 24 hour
measured in milliliter
24 hour
Wound complications
Time Frame: two week
infection-dehiscence
two week
Major intraoperative complications
Time Frame: 24 hour
bleeding -organ injury
24 hour
Major postoperative complications
Time Frame: two weeks
leak-bleeding
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of lymphadenectomy
Time Frame: one month
Number of lymph nodes retrieved
one month
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.
one month
Longitudinal safety margin
Time Frame: one month
either free or infiltrated with tumor by histopathology examination.
one month
short term oncologic outcome
Time Frame: 6 months - one year
incidence of local and distant outcomes and disease free survival
6 months - one year
Functional outcome
Time Frame: 3 months
assessing fecal incontinence using Kirwan's grading score
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Collaborators

Universidade da Coruña

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

August 29, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD/148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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