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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05245565
Other study ID # SHSY-IEC-4.1/21-311/01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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