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

NCT05245565 | Recruiting

• 1 other identifier: SHSY-IEC-4.1/21-311/01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectum Cancer; Stoma Colostomy; Faecal Incontinence; Leakage, Anastomotic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Rate of sphincter-preservation rates

  Within 30 days after operation

• The number of short-term postoperative complications

  Within 30 days after operation

• Postoperative hospital stay

  Within 30 days after operation

• Hospitalization costs

  Within 30 days after operation

• 30-Day Readmission Rate

  Within 30 days after operation

Study Arms (2)

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.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Encopresis; Anastomotic Leak

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; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Study Officials

• Cheng-Le Zhuang, MD, PhD

  Shanghai 10th People's Hospital

  STUDY CHAIR

Central Study Contacts

Cheng-Le Zhuang, MD, PhD

CONTACT

+86-19921618250; zhuangchengle@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator assistant

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 18, 2022
• Study Start: May 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)