Clinical trial · Interventional
Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.
A Randomized Controlled Study of Multi-technology Integration Total Mesorectal Excision (MTI-TME) Versus Conventional Total Mesorectal Excision (C-TME) for the Treatment of Middle and Distal Rectal Cancer.
NCT06613399CI-TRIAL-00081089not yet recruitingN/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)
A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer
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 |
|---|---|---|---|
| C-TME | Procedure | — | UNRESOLVED |
| MTI-TME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multi-Technology Integrated Total Mesorectal Excision,MTI-TME
- interventionNames
- Procedure: MTI-TME
- type
- PLACEBO_COMPARATOR
- label
- Conventional Total Mesorectal Excision,C-TME
- interventionNames
- Procedure: C-TME
Primary outcomes (1)
- measure
- anastomotic leakage rate
- timeFrame
- 1 year
Secondary outcomes (12)
- measure
- Operation time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must be aged 18 to 75. 2. Histopathological examination of the preoperative biopsy confirms adenocarcinoma. 3. Preoperative MRI shows the tumor\'s lower margin is below the umbilical ligament. 4. High-resolution CT and MRI do not indicate suspicious distant metastasis. 5. Participants\' general condition is acceptable, with an ASA score of ≤3 before surgery. 6. Participants must sign an informed consent form. Exclusion Criteria: 1. Developing other malignant tumors within 5 years; 2. Multiple primary colorectal tumors; 3. Pregnant or lactating women; 4. Patients with severe mental disorders; 5. Severe intestinal diseases; 6. Poor general condition and uncontrolled comorbidities; 7. Ineligible for laparoscopic surgery; 8. Participating in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.