Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer
NCT Number: NCT06567756
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rectum Cancer
Interventions: PROCEDURE: CSPO|PROCEDURE: ISR
Sponsor: Changhai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2030-09

Summary:
In this clinical trial, the investigators compared anal function, genitourinary function, quality of life, perioperative safety, and oncological prognosis after CSPO for patients with low rectal cancer, using ISR as a control, to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical approaches for patients with low rectal cancer.

Primary Outcome Measures: Wexner incontinence score, The scale was totaled from 0 to 20, with higher scores indicating more severe disease and poorer anal function., 12 months after protective stoma closure
Secondary Outcome Measures: LARS scoreIncontinence Score, The total score of the scale was 0-42, the higher the score, the more severe the condition and the worse the anal function, 0-20 indicated no LARS, 21-29 indicated minor LARS, and 30-42 indicated major LARS., 12 months after protective stoma closure|Quality of Life Questionaire-Core 30, A core scale for all cancer patients with 30 entries, each on a 4-point scale, rated 1 to 4. It can be categorized into 15 domains, with 5 functional domains (somatic, role, cognitive, emotional, and social functioning), 3 symptomatic domains (fatigue, pain, and nausea and vomiting), 1 domain of general health status/quality of life, and 6 single entries (each as a domain). The scores of the entries included in each domain were summed and divided by the number of entries included to obtain a score for that domain (Raw Score RS). In order to make the scores of each domain comparable with each other, a linear transformation was further performed using a polarization method to convert the rough score into a standardized score (SS) with values ranging from 0 to 100. Higher scores for the functional and general health domains indicate better functional status and quality of life, while higher scores for the symptom domain indicate more symptoms or problems (poorer quality of life)., 12 months after radical resection of rectal cancer and protective stoma closure|Overall survival, Overall Survival (OS) is the time from the start of randomization to death from any cause, and it is one of the best efficacy endpoints in oncology clinical trials. OS is usually the preferred endpoint when patient survival can be adequately assessed., 3 years|Clavien-Dindo complication grading, Grade 1 included minor risk events not requiring therapy (with exceptions of analgesic, antipyretic, antiemetic, and antidiarrheal drugs or drugs required for lower urinary tract infection). Grade 2 complications were defined as potentially life-threatening complications with the need of intervention or a hospital stay longer than twice the median hospitalization for the same procedure. Grade 2 was divided into 2 subgroups based on the invasiveness of the therapy selected to treat the complication; grade 2a complications required medications only and grade 2b an invasive procedure. Grade 3 complications were defined as complications leading to lasting disability or organ resection, and finally, a Grade 4 complication indicated death of a patient due to a complication., perioperative period