NCT Number: NCT06567756
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
The CSPO surgical approach is a series of targeted improvements designed primarily on the basis of analyzing the causes of poor postoperative function of the ISR, while building on research on the ultrastructure of the pelvic floor anal canal. For these reasons, the investigators designed the present study to compare anal function, quality of life, perioperative safety, and oncologic prognosis after CSPO for patients with low rectal cancer, using ISR surgery as a control, and to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical modalities for patients with low rectal cancer.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The distal rectum is freed to the entrance of the internal and external sphincter space, and then an oblique resection line is designed under direct vision according to the tumor site and shape, ensuring that the distal and lateral margins are not less than 1 cm, and preserving the contralateral dentate line and the intestinal wall as much as possible, and the anastomosis is completed manually or with instruments.
Partial, subtotal, or total excision of the internal sphincter and/or a portion of the longitudinal rectal muscle, expansion of the distal rectal excision margin into the anal canal or to the anal verge, and completion of the colo-anal anastomosis manually or instrumentally.
Time frame: 12 months after protective stoma closure
The scale was totaled from 0 to 20, with higher scores indicating more severe disease and poorer anal function.
Time frame: 12 months after protective stoma closure
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.
Time frame: 12 months after radical resection of rectal cancer and protective stoma closure
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).
Time frame: 3 years
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.
Time frame: perioperative period
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.
Changhai Hospital
Other
A Multicenter, Prospective, Randomized Controlled Clinical Trial of the Effect of Conformal Sphincter-preservation Operation Versus Intersphincteric Resection on Postoperative Anal Function in Patients With Low Rectal Cancer
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