Clinical trial · Interventional
Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases
A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer
NCT02421432CI-TRIAL-00053826unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case. Difficult case is defined as below; \- If any one of the following (1 or 2 or 3) 1. BMI: 30 or more 2. Tumor size: more than 7cm in long diameter 3. CRM: mesorectal fascia involvement or less than 1 mm on MRI
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transanal total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transanal total mesorectal excision
- description
- Laparoscopy-assisted transanal total mesorectal excision
- interventionNames
- Procedure: Transanal total mesorectal excision
Primary outcomes (1)
- measure
- TME quality & circumferential resection margin (CRM)
- timeFrame
- the day of surgery
- description
- The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * age: 20-80 years * biopsy-proven adenocarcinoma of the rectum * clinical staging (c or yc): T0-3, N0-2, M0 * Rectal cancer located 3-12 cm from the anal verge * ECOG performance status: 2 or less * If any one of the following (1 or 2 or 3) 1. BMI: 30 or more 2. Tumor size: more than 7cm in long diameter 3. CRM: mesorectal fascia involvement or less than 1 mm on MRI Exclusion Criteria: * Synchronous colon cancer or other malignancy * Obstructing rectal cancer * Pregnant or breast-feeding * Receiving any other study agents * Fecal incontinence * History of prior colorectal cancer or inflammatory bowel disease
References
Publications (0)
Data not yet available
No reference posted for this study.