NCT01340755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

April 21, 2011

Last Update Submit

September 1, 2017

Conditions

Adenocarcinoma of the Rectum

Keywords

Rectal cancer

Outcome Measures

Primary Outcomes (1)

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

    1-5 years

Secondary Outcomes (3)

  • 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

Study Arms (1)

Transanal endoscopic surgery

EXPERIMENTAL

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Procedure: Transanal endoscopic surgery

Interventions

Transanal endoscopic surgeryPROCEDURE

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Transanal endoscopic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Sylla P, Bordeianou LG, Berger D, Han KS, Lauwers GY, Sahani DV, Sbeih MA, Lacy AM, Rattner DW. A pilot study of natural orifice transanal endoscopic total mesorectal excision with laparoscopic assistance for rectal cancer. Surg Endosc. 2013 Sep;27(9):3396-405. doi: 10.1007/s00464-013-2922-7. Epub 2013 Apr 10.

    PMID: 23572214RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transanal Endoscopic Surgery

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Natural Orifice Endoscopic SurgeryEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisProctoscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Patricia Sylla, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 25, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)