Clinical trial · Interventional
Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME
Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
NCT02406118CI-TRIAL-00053814unknownN/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.
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 trananal TME
- 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: 1. age: 20-80 years 2. biopsy-proven adenocarcinoma of the rectum 3. clinical staging (c or yc): T0-3, N0-2, M0 4. Rectal cancer located 3-12 cm from the anal verge 5. ECOG performance status: 2 or less 6. BMI: less than 30 Exclusion Criteria: 1. Synchronous colon cancer or other malignancy 2. Obstructing rectal cancer 3. Pregnant or breast-feeding 4. Receiving any other study agents 5. Fecal incontinence 6. History of prior colorectal cancer or inflammatory bowel disease 7. Tumor size: more than 7cm in long diameter 8. CRM: mesorectal fascia involvement or less than 1 mm on MRI
References
Publications (1)
- DERIVEDPark SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058. PMID 29624549