Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Study Overview
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Brief Summary
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Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Based on the outcomes, the research doctors believe that this investigational surgery may be as safe and effective as standard laparoscopic or open surgery performed to remove rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions. In this research study, the investigators are looking to see if this investigational procedure is a safe and effective approach to remove rectal cancer of the mid and lower rectum.

Detailed Description
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Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. At the end of the procedure, the rectum will be removed though the anus, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Official Title
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A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Conditions
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Adenocarcinoma of the Rectum

Intervention / Treatment
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* Procedure: Transanal endoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven adenocarcinoma of the rectum Eligible to undergo standard open or laparoscopic low anterior resection with a temporary diverting stoma Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI Rectal cancer located 4-12 cm from the anal verge ECOG performance status 2 or less Exclusion Criteria: Metastasis Obstructing rectal cancer Synchronous colon cancer T3 rectal cancer not treated preoperatively with full-course chemoradiation Pregnant or breast-feeding Receiving any other study agents Fecal incontinence History of prior colorectal cancer History of inflammatory bowel disease History of pelvic radiation Prior pelvic surgery or multiple abdominal procedures BMI > 30 Large uterine fibroids Uncontrolled intercurrent illness Other malignancies diagnosed within the previous year, except basal cell cancer

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transanal endoscopic surgery<br>Laparoscopy-assisted transanal endoscopic rectosigmoid resection | Procedure: Transanal endoscopic surgery<br>* Laparoscopy-assisted transanal endoscopic rectosigmoid resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens. |  | 1-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications. |  | 1-5 years | 
| Incidence of long-term complications |  | 1-5 years | 
| Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection |  | 1-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer