Clinical trial · Interventional
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
- 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)
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic surgery with mini-laparotomy | Procedure | — | UNRESOLVED |
| NOSES VIIIA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NOSES VIIIA
- description
- totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
- interventionNames
- Procedure: NOSES VIIIA
- type
- ACTIVE_COMPARATOR
- label
- laparoscopic surgery with mini-laparotomy
- description
- laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy
- interventionNames
- Procedure: laparoscopic surgery with mini-laparotomy
Primary outcomes (1)
- measure
- disease-free survival rate
- timeFrame
- 3 years after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * volunteer to participate and the informed consent signed; * 18-75 years; * female who have given birth; * pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy; * preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm; * preoperative staging cT1-3NanyM0 * body mass index \<30 kg/m2; * willing to undergo laparoscopic right hemicolectomy Exclusion Criteria: * contraindications for laparoscopic surgery; * emergency surgery due to acute intestinal obstruction, perforation or bleeding; * distant metastasis; * multiple colorectal cancer; * has received preoperative chemoradiotherapy; * with a history of other malignant tumors; * unwilling to sign the informed consent or receive follow-up according to the study protocol.
References
Publications (1)
- DERIVEDYu M, Cai Z, Zhou H, Fingerhut A, He Z, Xue P, Song H, Yang X, Cheng X, Zhang S, Xu X, Zhong H, Abuduaini N, Liu J, Wang X, Feng B. Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy. Future Oncol. 2023 Dec;19(40):2641-2650. doi: 10.2217/fon-2023-0769. Epub 2023 Dec 18. PMID 38108112