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NOT YET RECRUITING
NCT06567756
NA

Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

In this clinical trial, the investigators compared anal function, genitourinary function, quality of life, perioperative safety, and oncological prognosis after CSPO for patients with low rectal cancer, using ISR as a control, to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical approaches for patients with low rectal cancer.

Official title: A Multicenter, Prospective, Randomized Controlled Clinical Trial of the Effect of Conformal Sphincter-preservation Operation Versus Intersphincteric Resection on Postoperative Anal Function in Patients With Low Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-09

Completion Date

2030-09

Last Updated

2024-08-23

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

CSPO

The distal rectum is freed to the entrance of the internal and external sphincter space, and then an oblique resection line is designed under direct vision according to the tumor site and shape, ensuring that the distal and lateral margins are not less than 1 cm, and preserving the contralateral dentate line and the intestinal wall as much as possible, and the anastomosis is completed manually or with instruments.

PROCEDURE

ISR

Partial, subtotal, or total excision of the internal sphincter and/or a portion of the longitudinal rectal muscle, expansion of the distal rectal excision margin into the anal canal or to the anal verge, and completion of the colo-anal anastomosis manually or instrumentally.