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

Phase 1
18 Years
Open (Enrolling)
Adenocarcinoma of the Rectum

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1-5 years

Safety Issue:


Principal Investigator

Patricia Sylla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

May 2017

Related Keywords:

  • Adenocarcinoma of the Rectum
  • Rectal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617