Status:
NOT_YET_RECRUITING
Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer
Lead Sponsor:
Changhai Hospital
Conditions:
Rectum Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 cance...
Detailed Description
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 ult...
Eligibility Criteria
Inclusion
- Age: 18-75 years;
- Pathologically confirmed: moderately \& well-differentiated rectal cancer;
- Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
- Tumor diameter: ≤3cm or \<1/3 bowel circumference;
- Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
- Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
- ASA score: I-III and ECOG score: 0-1;
- Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
- Normal preoperative anal function: Wexner score \<10, LARS score \<20;
- Agree to participate in the clinical trial and sign an informed consent form.
Exclusion
- Combination of synchronous or metachronous (within 5 years) malignant tumors;
- Combined distant metastasis of the tumor;
- Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
- Combined psychiatric disorders that do not allow them to understand and participate in the study;
- Combined systemic diseases that cannot tolerate surgery;
- Women who are pregnant or breastfeeding;
- Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06567756
Start Date
September 1 2024
End Date
September 1 2030
Last Update
August 23 2024
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