Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer

NCT00470951

Rectal Cancer

UNKNOWN PHASE3

Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

NCT00726622

Colorectal Cancer

COMPLETED PHASE3

Feasibility Bowel Dysfunction Program After Low Anterior Resection

NCT04733794

Rectal Cancer Low Anterior Resection

COMPLETED NA

Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site

NCT03422835

Rectal Neoplasms

UNKNOWN PHASE2

Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

NCT03209076

Rectal Neoplasms Sexual Dysfunction Urinary Incontinence +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenocarcinoma of the Rectum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transanal endoscopic surgery

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Group Type EXPERIMENTAL

Transanal endoscopic surgery

Intervention Type PROCEDURE

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transanal endoscopic surgery

Laparoscopy-assisted transanal endoscopic rectosigmoid resection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No