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NCT05503381
A Randomized, Controlled, Multicenter, Noninferiority Clinical Study of Perioperative and Oncological Safety in Patients With Rectal Cancer
NA trial testing Laparoscopic radical resection of low rectal cancer with transanal specimens in Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University in 500 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Changhai Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 1 January 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Laparoscopic radical resection of low rectal cancer with transanal specimens
Conditions studied
- Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University — all drugs for Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University →
Sponsor
Changhai Hospital
Who can join
Adults 18 to 75, any sex, with Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05503381
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05503381 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changhai Hospital
- Last refreshed: 16 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05503381.
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