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NCT Number: NCT01340755

Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

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.

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Key information

Conditions

Adenocarcinoma of the Rectum Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transanal endoscopic surgery

Procedure

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Primary outcomes

  1. Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.

    Time frame: 1-5 years

Secondary outcomes

  1. Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.

    Time frame: 1-5 years

  2. Incidence of long-term complications

    Time frame: 1-5 years

  3. Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection

    Time frame: 1-5 years

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2017
First posted
Apr 25, 2011
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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