Clinical trial · Interventional
Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSPO | Procedure | — | UNRESOLVED |
| ISR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (experimental group): CSPO group
- description
- The distal rectum is isolated 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 intestinal wall as much as possible, and completing the anastomosis manually or with instruments.
- interventionNames
- Procedure: CSPO
- type
- ACTIVE_COMPARATOR
- label
- Group B (control group): ISR group
- description
- Partial, subtotal, or complete resection of the internal sphincter and/or a portion of the longitudinal rectal muscle, expansion of the distal rectal incision margin into the anal canal or to the anal verge, and completion of colorectal-anal anastomosis manually or instrumentally
- interventionNames
- Procedure: ISR
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available