Clinical trial · Interventional
Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
NCT02830633CI-TRIAL-00023032unknownPhase 2ClinicalTrials.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 to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.
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 |
|---|---|---|---|
| LNTME | Procedure | — | UNRESOLVED |
| OTME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LNTME
- description
- Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients
- interventionNames
- Procedure: LNTME
- type
- ACTIVE_COMPARATOR
- label
- OTME
- description
- Open TME (OTME) is conducted in rectal cancer patients
- interventionNames
- Procedure: OTME
Primary outcomes (3)
- measure
- Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
- timeFrame
- postoperative 30 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients 2. From 18 years old to 60 years old 3. Normal sexual function 4. Tumor located in rectum (defined as 5- to 12-cm from the anal verge) 5. Pathological confirmed rectal cancer 6. Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual 7. Tumor size \< 5 cm 8. ASA score was I-II 9. Informed consent was written Exclusion Criteria: 1. Distant cancer metastasis 2. History of abdominal surgery 3. With other type of malignancy 4. Preoperative voiding dysfunction 5. Preoperative sexual dysfunction 6. Refusing to attend this trial
References
Publications (1)
- DERIVEDHe Y, Zhu Z, Liu S, Liu L, Hu B, Wan X, Huang Q. [Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Apirl 25;21(4):431-436. Chinese. PMID 29682715