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Not yet recruiting NCT06567756

Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer

No phase Interventional Rectum Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CSPO, ISR.
Who it may be relevant to
Registry conditions: Rectum Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure CSPO
    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.
  • Procedure ISR
    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.

Primary outcome measures

  • Wexner incontinence score [Time frame: 12 months after protective stoma closure]
Secondary outcome measures (4)
  • LARS scoreIncontinence Score [Time frame: 12 months after protective stoma closure]
  • Quality of Life Questionaire-Core 30 [Time frame: 12 months after radical resection of rectal cancer and protective stoma closure]
  • Overall survival [Time frame: 3 years]
  • Clavien-Dindo complication grading [Time frame: perioperative period]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06567756 · CSVIS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗