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

NCT06567756 | Not Yet Recruiting

• 1 other identifier: CSVIS
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rectum Cancer

Keywords

low rectum cancer; CSPO; ISR; anal function

Outcome Measures

Primary Outcomes (1)

• Wexner incontinence score

  The scale was totaled from 0 to 20, with higher scores indicating more severe disease and poorer anal function.

  12 months after protective stoma closure

Secondary Outcomes (4)

• LARS scoreIncontinence Score

  12 months after protective stoma closure

• Quality of Life Questionaire-Core 30

  12 months after radical resection of rectal cancer and protective stoma closure

• Overall survival

  3 years

• Clavien-Dindo complication grading

  perioperative period

Study Arms (2)

Group A (experimental group): CSPO group

EXPERIMENTAL

The distal rectum is isolated 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 intestinal wall as much as possible, and completing the anastomosis manually or with instruments.

Procedure: CSPO

Group B (control group): ISR group

ACTIVE COMPARATOR

Partial, subtotal, or complete resection of the internal sphincter and/or a portion of the longitudinal rectal muscle, expansion of the distal rectal incision margin into the anal canal or to the anal verge, and completion of colorectal-anal anastomosis manually or instrumentally

Procedure: ISR

Interventions

CSPO PROCEDURE

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.

Group A (experimental group): CSPO group

ISR PROCEDURE

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.

Group B (control group): ISR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years;
• Pathologically confirmed: moderately \& well-differentiated rectal cancer;
• Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
• Tumor diameter: ≤3cm or \<1/3 bowel circumference;
• Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
• Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
• ASA score: I-III and ECOG score: 0-1;
• Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
• Normal preoperative anal function: Wexner score \<10, LARS score \<20;
• Agree to participate in the clinical trial and sign an informed consent form.

You may not qualify if:

• Combination of synchronous or metachronous (within 5 years) malignant tumors;
• Combined distant metastasis of the tumor;
• Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
• Combined psychiatric disorders that do not allow them to understand and participate in the study;
• Combined systemic diseases that cannot tolerate surgery;
• Women who are pregnant or breastfeeding;
• Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: August 23, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share