Rectum CancerNCT06567756

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

A study testing CSPO and ISR in people with Rectum Cancer, run by Changhai Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rectum Cancer
What is being tested?: CSPO and ISR
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: No sites listed yet
Study dates: Sep 2024to Sep 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Rectum Cancer
Being tested: CSPO, ISR
Keywords: low rectum cancer, CSPO, ISR, anal function
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CSPOProcedure or surgery
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.
ISRProcedure or surgery
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.

Study groups in NCT06567756
Study group	Role	What they receive
Group A (experimental group): CSPO group	Experimental	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. Receives: Procedure: CSPO
Group B (control group): ISR group	Active comparator	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 Receives: Procedure: ISR

What is being measured

The primary outcome is the main question the study is designed to answer.

Wexner incontinence score
The scale was totaled from 0 to 20, with higher scores indicating more severe disease and poorer anal function.
Measured: 12 months after protective stoma closure

Secondary outcomes (4)

LARS scoreIncontinence Score
The total score of the scale was 0-42, the higher the score, the more severe the condition and the worse the anal function, 0-20 indicated no LARS, 21-29 indicated minor LARS, and 30-42 indicated major LARS.
Measured: 12 months after protective stoma closure
Quality of Life Questionaire-Core 30
A core scale for all cancer patients with 30 entries, each on a 4-point scale, rated 1 to 4. It can be categorized into 15 domains, with 5 functional domains (somatic, role, cognitive, emotional, and social functioning), 3 symptomatic domains (fatigue, pain, and nausea and vomiting), 1 domain of general health status/quality of life, and 6 single entries (each as a domain). The scores of the entries included in each domain were summed and divided by the number of entries included to obtain a score for that domain (Raw Score RS). In order to make the scores of each domain comparable with each other, a linear transformation was further performed using a polarization method to convert the rough score into a standardized score (SS) with values ranging from 0 to 100. Higher scores for the functional and general health domains indicate better functional status and quality of life, while higher scores for the symptom domain indicate more symptoms or problems (poorer quality of life).
Measured: 12 months after radical resection of rectal cancer and protective stoma closure
Overall survival
Overall Survival (OS) is the time from the start of randomization to death from any cause, and it is one of the best efficacy endpoints in oncology clinical trials. OS is usually the preferred endpoint when patient survival can be adequately assessed.
Measured: 3 years
Clavien-Dindo complication grading
Grade 1 included minor risk events not requiring therapy (with exceptions of analgesic, antipyretic, antiemetic, and antidiarrheal drugs or drugs required for lower urinary tract infection). Grade 2 complications were defined as potentially life-threatening complications with the need of intervention or a hospital stay longer than twice the median hospitalization for the same procedure. Grade 2 was divided into 2 subgroups based on the invasiveness of the therapy selected to treat the complication; grade 2a complications required medications only and grade 2b an invasive procedure. Grade 3 complications were defined as complications leading to lasting disability or organ resection, and finally, a Grade 4 complication indicated death of a patient due to a complication.
Measured: perioperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2024Sep 2030

First posted23 Aug 2024
Study startSep 2024 (estimated)
Primary completionSep 2027 (estimated)
Study completionSep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rectum CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06567756
Sponsor's protocol ID: CSVIS
Status last verified: Jan 2024
First submitted: 2 Jan 2024
Last updated: 23 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingPhase 2
Adaptive Radiotherapy for Safe Hypofractionation
Cancer, Endometrial Cancer
Not yet recruitingPhase 2
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer
Colo-rectal Cancer
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma

All Rectum Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06567756
Acronym / sponsor ID: CSVIS
Conditions: Rectum Cancer
Keywords: low rectum cancer, CSPO, ISR, anal function
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: Changhai HospitalUniversity, hospital or other
Study start: Sep 2024 (estimated)
Primary completion: Sep 2027 (estimated)
Study completion: Sep 2030 (estimated)
First posted: 23 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A (experimental group): CSPO group	Experimental	Procedure: CSPOThe 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.
Group B (control group): ISR group	Active comparator	Procedure: ISRPartial, 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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CSPOThe 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 or surgery	Group A (experimental group): CSPO group
ISRPartial, 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.	Procedure or surgery	Group B (control group): ISR group

Primary outcome

Wexner incontinence score
Time frame: 12 months after protective stoma closure
The scale was totaled from 0 to 20, with higher scores indicating more severe disease and poorer anal function.

4 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Individual participant dataSharing planned: No

Related trials for Rectum Cancer

Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingPhase 2
Adaptive Radiotherapy for Safe Hypofractionation
Cancer, Endometrial Cancer
Not yet recruitingPhase 2
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Combined With Penpulimab and Fruquintinib for Advanced Colorectal Cancer
Colo-rectal Cancer
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing CSPO and ISR in people with Rectum Cancer, run by Changhai Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wexner incontinence score (time frame: 12 months after protective stoma closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06567756.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.