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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Tenth People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Cheng-Le Zhuang, MD, PhD
zhuangchengle@tongji.edu.cn
+86-19921618250
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai 10th People's Hospital

This content was sourced from clinicaltrials.gov

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