Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | May 2017 |
A Pilot Study of 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.
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.
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.
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
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
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