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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
Sponsor:
Collaborator:
Universidade da Coruña
Information provided by (Responsible Party):
Islam Hany Metwally, Mansoura University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: natural orifice specimen extraction Procedure: Laparoendoscopic resection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility [ Time Frame: 24 hour ]
    Rate of conversion to classic laparoscopy or to open laparotomy.

  2. operative time [ Time Frame: 24 hour ]
    time taken from starting operation till patient wake up

  3. Operative blood loss [ Time Frame: 24 hour ]
    measured in milliliter

  4. Wound complications [ Time Frame: two week ]
    infection-dehiscence

  5. Major intraoperative complications [ Time Frame: 24 hour ]
    bleeding -organ injury

  6. Major postoperative complications [ Time Frame: two weeks ]
    leak-bleeding


Secondary Outcome Measures :
  1. Adequacy of lymphadenectomy [ Time Frame: one month ]
    Number of lymph nodes retrieved

  2. 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.

  3. Longitudinal safety margin [ Time Frame: one month ]
    either free or infiltrated with tumor by histopathology examination.

  4. short term oncologic outcome [ Time Frame: 6 months - one year ]
    incidence of local and distant outcomes and disease free survival

  5. Functional outcome [ Time Frame: 3 months ]
    assessing fecal incontinence using Kirwan's grading score


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Islam H Metwally, M.Sc 01002985865 ext 02 dr.islamo@hotmail.com

Locations
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Egypt
Oncology center Mansoura University Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: Islam H Metwally, M.Sc    01002985865 ext 02    drislamhany@mans.edu.eg   
Sub-Investigator: Mohamed A Hegazy, MD         
Sub-Investigator: Waleed E Rashad, MD         
Sponsors and Collaborators
Mansoura University
Universidade da Coruña
Investigators
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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
More Information
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Responsible Party: Islam Hany Metwally, Assistant lecturer of surgical oncology, Mansoura University
ClinicalTrials.gov Identifier: NCT02549456    
Other Study ID Numbers: MD/148
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Keywords provided by Islam Hany Metwally, Mansoura University:
natural orifice surgery
natural orifice specimen extraction
taTME
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases