Clinical trial · Interventional
Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
NCT04230772CI-TRIAL-00042923NOTRunknownN/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)
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Complication of Surgical Procedure | — | UNRESOLVED | — |
| Natural Orifice Specimen Extraction Surgery | — | UNRESOLVED | — |
| Neoplasms Malignant | Malignant Neoplasm | ALIAS | 0.90 |
| Robotic Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Natural Orifice Specimen Extraction Surgery | Procedure | — | UNRESOLVED |
| Traditional Robotic-assisted Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Natural Orifice Specimen Extraction Surgery
- description
- Natural orifice specimen extraction surgery will performed in patients assigned to this group.
- interventionNames
- Procedure: Natural Orifice Specimen Extraction Surgery
- type
- ACTIVE_COMPARATOR
- label
- Traditional Robotic-assisted Surgery
- description
- Traditional robotic-assisted surgery will performed in patients assigned to this group.
- interventionNames
- Procedure: Traditional Robotic-assisted Surgery
Primary outcomes (1)
- measure
- Incidence of surgical complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 and ≤ 80 years; 2. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale; 3. Histological or cytological confirmation of colorectal adenocarcinoma; 4. High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line; 5. T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of \<5 cm; 6. Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs; 7. Cardiopulmonary liver and kidney function can withstand surgery; 8. Written informed consent for participation in the trial. Exclusion Criteria: 1. Not suitable for robot laparoscopic surgery; 2. The tumor is too large to be pulled out through the anus or vagina; 3. Simultaneous multiple primary cancer; 4. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer 5. Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
References
Publications (1)
- DERIVEDLuo R, Zheng F, Zhang H, Zhu W, He P, Liu D. Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial. Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z. PMID 33549133