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Trial Title:
Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer
NCT ID:
NCT06567756
Condition:
Rectum Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
low rectum cancer
CSPO
ISR
anal function
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
CSPO
Description:
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.
Arm group label:
Group A (experimental group): CSPO group
Intervention type:
Procedure
Intervention name:
ISR
Description:
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.
Arm group label:
Group B (control group): ISR group
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.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-75 years;
2. Pathologically confirmed: moderately & well-differentiated rectal cancer;
3. Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate
line;
4. Tumor diameter: ≤3cm or <1/3 bowel circumference;
5. Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
6. Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and
downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
7. ASA score: I-III and ECOG score: 0-1;
8. Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
9. Normal preoperative anal function: Wexner score <10, LARS score <20;
10. Agree to participate in the clinical trial and sign an informed consent form.
Exclusion Criteria:
1. Combination of synchronous or metachronous (within 5 years) malignant tumors;
2. Combined distant metastasis of the tumor;
3. Combined intestinal obstruction, intestinal perforation, or intestinal bleeding
requiring emergency surgery;
4. Combined psychiatric disorders that do not allow them to understand and participate
in the study;
5. Combined systemic diseases that cannot tolerate surgery;
6. Women who are pregnant or breastfeeding;
7. Other reasons, judged by the investigator, for not being suitable for participation
in this clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 2024
Completion date:
September 2030
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567756
