Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Procedure: natural orifice specimen extraction; Procedure: Laparoendoscopic resection

• Registration Number: NCT02549456
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study First Submitted: 2015-08-29
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-15
• Study Start: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural orifice specimen extraction	natural orifice specimen extraction	Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction
Laparoendoscopic resection	Laparoendoscopic resection	Laparoscopic assisted transanal endoscopic resection of rectal cancer

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oncology center Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt