Clinical trial · Interventional
A Randomized, Controlled, Multicenter, Noninferiority Clinical Study of Perioperative and Oncological Safety in Patients With Rectal Cancer
A Randomized, Controlled, Multicenter, Noninferiority Study of Perioperative and Oncological Safety of Transanal Laparoscopic Radical Resection of Low Rectal Cancer (NOSES I) Compared With Conventional Laparoscopic Assisted Surgery for Low Rectal Cancer
- 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)
Laparoscopic natural orifice specimen extraction surgery (NOSES) for low rectal cancer has a good minimally invasive effect. However, the NOSES prognosis studies are all small sample retrospective studies. This study conducted a multicenter prospective randomized controlled trial of NOSES surgery for low rectal cancer to compare the difference in surgical outcomes between conventional laparoscopic surgery and NOSES surgery for low rectal cancer. A total of 500 patients were planned to be enrolled, including 250 in the control group and 250 in the experimental group. The primary end point was 2-year disease-free survival (DFS), and the secondary end points were surgical safety, postoperative pathology, postoperative defecation, urination, and sexual function. Through a large sample size study, this study aims to clarify the advantages of NOSE surgery for low rectal cancer, promote the promotion of low rectal cancer NOSES surgery in the country, standardize the way of low rectal cancer NOSES surgery, improve the surgical treatment of patients with low rectal cancer, improve the quality of life of patients, reduce the burden of patients, and increase the satisfaction. And improve the international influence of the project team in the field of minimally invasive surgical treatment of colorectal 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 |
|---|---|---|---|
| Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic radical resection of low rectal cancer with transanal specimens | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Natural Orifice Specimen Extraction Surgery Group
- description
- The patient underwent laparoscopic lower rectal cancer surgery with transanal specimen collection
- interventionNames
- Procedure: Laparoscopic radical resection of low rectal cancer with transanal specimens
- type
- NO_INTERVENTION
- label
- Traditional laparoscopic surgery
- description
- The patient underwent conventional laparoscopic lower rectal cancer surgery
Primary outcomes (1)
- measure
- disease-free survival rate
- timeFrame
- 2-year
- description
- After the postoperative review, the patient had no tumor recurrence and metastasis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients were aged between 18 and 75 years; 2. Pathologically confirmed as adenocarcinoma; 3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin was ≤ 5cm; 4. Preoperative imaging diagnosis was ct1-3nxm0; 5. Preoperative colonoscopy or imaging diagnosis confirmed that the maximum diameter of the tumor was not more than 5cm; 6. Body mass index (BMI) ≤ 30kg / m2; 7. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no puncture Formation of pores and abscesses without invasion of adjacent organs); 8. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia; 9. Voluntary informed consent. Exclusion Criteria: 1. Preoperative evaluation of patients with lateral lymph node metastasis; 2. Previous history of malignant tumor; 3. Simultaneous multiple primary colorectal cancer was diagnosed; 4. There are contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency; 5. Patients who had undergone abdominal and pelvic surgery for many times or had extensive abdominal adhesions; 6. Patients with intestinal obstruction, intestinal perforation, intestinal hemorrhage and other emergency operations; 7. Patients with familial adenomatous polyposis, Lynch syndrome associated rectal cancer, and inflammatory bowel disease in the active phase; 8. Have a history of serious mental illness; 9. Pregnant or lactating women; 10. Patients with uncontrolled infection before operation; 11. The investigator considered that the patient should not participate in the trial.
References
Publications (0)
Data not yet available