Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

NCT ID: NCT02549456

Last Updated: 2017-03-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natural orifice specimen extraction

Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction

Group Type EXPERIMENTAL

natural orifice specimen extraction

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Laparoendoscopic resection

Intervention Type PROCEDURE

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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade da Coruña

OTHER

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Islam Hany Metwally

Assistant lecturer of surgical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Islam H Metwally, M.Sc

Role: CONTACT

01002985865 ext. 02

Facility Contacts

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Islam H Metwally, M.Sc

Role: primary

01002985865 ext. 02

Other Identifiers

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MD/148

Identifier Type: -

Identifier Source: org_study_id

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