Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

Study Overview
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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.

Official Title
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Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: natural orifice specimen extraction
* Procedure: Laparoendoscopic resection


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Natural orifice specimen extraction<br>Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction | Procedure: natural orifice specimen extraction<br>* Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).<br>|
| Experimental: Laparoendoscopic resection<br>Laparoscopic assisted transanal endoscopic resection of rectal cancer | Procedure: Laparoendoscopic resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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natural orifice surgery, natural orifice specimen extraction, taTME