Clinical trial · Interventional
Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transanal endoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transanal endoscopic surgery
- description
- Laparoscopy-assisted transanal endoscopic rectosigmoid resection
- interventionNames
- Procedure: Transanal endoscopic surgery
Primary outcomes (1)
- measure
- Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
- timeFrame
- 1-5 years
Secondary outcomes (3)
- measure
- Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
- timeFrame
- 1-5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSylla 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 23572214