Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Recruiting

• Conditions: Rectum Cancer; Stoma Colostomy; Leakage, Anastomotic; Faecal Incontinence

• Registration Number: NCT05245565
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.

PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum
2. The lower edge of tumor < 3 cm from the dentate line
3. Clinical T stage ≤ T3

Exclusion Criteria

1. The lower edge of tumor < 1 cm from the dentate line
2. Locally advanced stage of tumor
3. Presence of metastatic disease or recurrent rectal tumor
4. Concomitant malignancies
5. Concurrent uncontrolled medical conditions
6. Impaired anal function before surgery
7. Presence of acute bowel obstruction or bowel perforation caused by cancer
8. Pregnancy or breast feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients who develop anastomotic leakage	Within 30 days after operation	The percentage of patients who develop anastomotic leakage
Postoperative anal function assessed by Wexner scale	2 years since the start of treatment	Ranging from 0 (perfect continence) to 20 (complete incontinence)
Rate of temporary defunctioning stoma	Within 30 days after operation	The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.
Postoperative anal function assessed by Vaizey scale	2 years since the start of treatment	Ranging from 0 (perfect continence) to 24 (complete incontinence)

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital stay	Within 30 days after operation	The time between the operation date and the discharge date.
Hospitalization costs	Within 30 days after operation	The total cost of hospitalization
30-Day Readmission Rate	Within 30 days after operation	Percentage of readmitted patients within 30 days after operation
Disease-free survival	Up to 5 years after the last patient recruited	Disease-free survival is defined as the time from surgery to recurrence of tumor or death
Overall survival	Up to 5 years after the last patient recruited	Overall survival is defined as the time from surgery until death from any cause.
Rate of sphincter-preservation rates	Within 30 days after operation	The percentage of patients who preserve the anatomical structure of the anus
The number of short-term postoperative complications	Within 30 days after operation	The number of grade II and higher postoperative complications according to the Clavien-Dindo classification

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China