NCT06567756Not yet recruiting
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 · Last updated 23 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 2 Jan 2024
- Start date
- Sept 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Changhai Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06567756
What you commit to
- Study type: Interventional
- Planned participants: 84
- From Sept 2024 to the primary completion date, Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Combination of synchronous or metachronous (within 5 years) malignant tumors;
- 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;
Other
- Combined distant metastasis of the tumor;
- Women who are pregnant or breastfeeding;
- Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.