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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Cheng-Le Zhuang, MD, PhD; Phone Number: +86-19921618250; Email: zhuangchengle@tongji.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: Cheng-Le Zhuang, MD, PhD; Email: zhuangchengle@tongji.edu.cn
      • Principal Investigator: Cheng-Le Zhuang, MD, PhD
      • Principal Investigator: Zhong-Chen Liu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our study population is the patients who diagnosed as low-lying rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PPS surgery; Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer.
Conventional; Patients who undergo conventional sphincter-preserving surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The percentage of patients who develop anastomotic leakage	The percentage of patients who develop anastomotic leakage	Within 30 days after operation
Postoperative anal function assessed by Wexner scale	Ranging from 0 (perfect continence) to 20 (complete incontinence)	2 years since the start of treatment
Postoperative anal function assessed by Vaizey scale	Ranging from 0 (perfect continence) to 24 (complete incontinence)	2 years since the start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of sphincter-preservation rates	The percentage of patients who preserve the anatomical structure of the anus	Within 30 days after operation
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
Postoperative hospital stay	The time between the operation date and the discharge date.	Within 30 days after operation
Hospitalization costs	The total cost of hospitalization	Within 30 days after operation
30-Day Readmission Rate	Percentage of readmitted patients within 30 days after operation	Within 30 days after operation
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
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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Cheng-Le Zhuang, MD, PhD, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anastomotic Leak; Fecal Incontinence
• Other Study ID Numbers: SHSY-IEC-4.1/21-311/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No