Clinical trial · Interventional
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer
NCT03413930CI-TRIAL-00043420withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding was raised
Summary
Brief summary (as posted)
This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic total mesorectal excision | Procedure | — | UNRESOLVED |
| Transanal total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TaTME
- description
- Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）
- interventionNames
- Procedure: Transanal total mesorectal excision
- type
- ACTIVE_COMPARATOR
- label
- LaTME
- description
- Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision.
- interventionNames
- Procedure: Laparoscopic total mesorectal excision
Primary outcomes (1)
- measure
- Circumferential resection margin (CRM)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years \< age \< 80 years * Body mass index (BMI) \<30 kg/m2 * Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection) * Pathological rectal carcinoma * Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history * Tumor size of 5 cm or less * ECOG score is 0-1 * ASA score is Ⅰ-Ⅲ * Informed consent Exclusion Criteria: * Requiring a Mile's procedure * Fecal incontinence * History of inflammatory bowel disease * Pregnant woman or lactating woman * Severe mental disease * Intolerance of surgery for severe comorbidities * Previous abdominal surgery * Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer * Requirement of simultaneous surgery for other disease
References
Publications (3)
- BACKGROUNDSimillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151. PMID 26466751
- BACKGROUNDFernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865. PMID 25185463
- BACKGROUNDDeijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4. PMID 26537907