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

Rectum Cancer Clinical Trial

Official title:

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245565
• Other study ID #: SHSY-IEC-4.1/21-311/01
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2023
• Source: Shanghai 10th People's Hospital
• Contact: Cheng-Le Zhuang, MD, PhD
• Phone: +86-19921618250
• Email: zhuangchengle[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Faecal Incontinence
• Fecal Incontinence
• Leakage, Anastomotic
• Rectal Neoplasms
• Rectum Cancer
• Stoma Colostomy

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of temporary defunctioning stoma	The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.	Within 30 days after operation
Primary	The percentage of patients who develop anastomotic leakage	The percentage of patients who develop anastomotic leakage	Within 30 days after operation
Primary	Postoperative anal function assessed by Wexner scale	Ranging from 0 (perfect continence) to 20 (complete incontinence)	2 years since the start of treatment
Primary	Postoperative anal function assessed by Vaizey scale	Ranging from 0 (perfect continence) to 24 (complete incontinence)	2 years since the start of treatment
Secondary	Rate of sphincter-preservation rates	The percentage of patients who preserve the anatomical structure of the anus	Within 30 days after operation
Secondary	The number of short-term postoperative complications	The number of grade II and higher postoperative complications according to the Clavien-Dindo classification	Within 30 days after operation
Secondary	Postoperative hospital stay	The time between the operation date and the discharge date.	Within 30 days after operation
Secondary	Hospitalization costs	The total cost of hospitalization	Within 30 days after operation
Secondary	30-Day Readmission Rate	Percentage of readmitted patients within 30 days after operation	Within 30 days after operation
Secondary	Disease-free survival	Disease-free survival is defined as the time from surgery to recurrence of tumor or death	Up to 5 years after the last patient recruited
Secondary	Overall survival	Overall survival is defined as the time from surgery until death from any cause.	Up to 5 years after the last patient recruited