Rectum CancerNCT06601985
Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer.
An observational study of Rectum Cancer and Faecal Incontinence, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer, Faecal Incontinence, Faecal Incontinence with Faecal Urgency
- What is being tested?
- J-pouch anastomosis and direct anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 11 Apr 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study population is the patients who diagnosed as ultra-low rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.
Who may be able to join
- A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour \<5 cm from the anus or \<3 cm from the dentate line, and treated with anus-preserving surgery;
- No distant metastasis;
- Age \>18 years old;
- Voluntary enrollment in the study and signing of an informed consent.
Who cannot join
- A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
- preoperative anal stenosis and anal nonfunction;
- temporary stoma diversion.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital, Yanchang Road, Jing'an District, Shanghai, China
Shanghai, Jingan, 200040
About this study
Official title: Exploring the Effect of Applying Colonic J-pouch Forming in Anorectal Preservation Surgery for Ultra-low Rectal Cancer on Postoperative Bowel Control Function
The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.
- Conditions
- Rectum Cancer, Faecal Incontinence, Faecal Incontinence with Faecal Urgency, Low Anterior Resection Syndrome, Leakage, Anastomotic
- Being tested
- J-pouch anastomosis, direct anastomosis
- Medical subject headings
- Rectal Neoplasms, Encopresis, Low Anterior Resection Syndrome, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-pouch anastomosisProcedure or surgery
Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch.
direct anastomosisProcedure or surgery
Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| J-pouch anastomosis group | Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch. Receives: Procedure: J-pouch anastomosis | |
| direct anastomosis group | Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis. Receives: Procedure: direct anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS score
The LARS scale has five questions with a total score of 42. A score of 0-20 lacks diagnostic value for LARS, while a score of 21-29 indicates mild LARS and a score above 29 indicates major LARS.
Measured: From 1 month postoperatively to 12 months postoperatively
FIQL
The FIQL is a specific quality-of-life assessment scale applicable to the symptoms of colorectal cancer patients. It comprises 29 items, which are divided into four dimensions: lifestyle (10 items), coping/behavior restriction(9 items), depression/self-perception (7 items), and embarrassment (3 items).
Measured: From 1 month postoperatively to 12 months postoperatively
Vaizey score
The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
Measured: From 1 month postoperatively to 12 months postoperatively
Wexner score
The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
Measured: From 1 month postoperatively to 12 months postoperatively
Secondary outcomes (1)
Surgical complications
Records post-operative anastomotic fistula, infection, bleeding, etc.
Measured: From 1 month postoperatively to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2022
- Primary completion11 Mar 2025 (estimated)
- Study completion11 Apr 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Feng-Min, Shanghai 10th People's Hospital
- Investigators
- Cheng-Le Zhuang, MD, PhD, Study chair, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601985
- Sponsor's protocol ID
- 24K30
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Applying Colonic J-pouch Forming in Anorectal Preservation Surgery for Ultra-low Rectal Cancer on Postoperative Bowel Control Function
- ClinicalTrials.gov ID
- NCT06601985
- Acronym / sponsor ID
- 24K30
- Conditions
- Rectum Cancer, Faecal Incontinence, Faecal Incontinence with Faecal Urgency, Low Anterior Resection Syndrome, Leakage, Anastomotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 11 Mar 2025 (estimated)
- Study completion
- 11 Apr 2025 (estimated)
- First posted
- 19 Sep 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.
The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| J-pouch anastomosis group | – | Procedure: J-pouch anastomosisPatient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch. |
| direct anastomosis group | – | Procedure: direct anastomosisPatient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population is the patients who diagnosed as ultra-low rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.
Key inclusion criteria (4 listed)
- A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour \<5 cm from the anus or \<3 cm from the dentate line, and treated with anus-preserving surgery;
- No distant metastasis;
- Age \>18 years old;
- Voluntary enrollment in the study and signing of an informed consent.
Key exclusion criteria (3 listed)
- A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
- preoperative anal stenosis and anal nonfunction;
- temporary stoma diversion.
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 |
|---|---|---|
| J-pouch anastomosisPatient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch. | Procedure or surgery | J-pouch anastomosis group |
| direct anastomosisPatient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis. | Procedure or surgery | direct anastomosis group |
Primary outcome
LARS score
Time frame: From 1 month postoperatively to 12 months postoperatively
The LARS scale has five questions with a total score of 42. A score of 0-20 lacks diagnostic value for LARS, while a score of 21-29 indicates mild LARS and a score above 29 indicates major LARS.
FIQL
Time frame: From 1 month postoperatively to 12 months postoperatively
The FIQL is a specific quality-of-life assessment scale applicable to the symptoms of colorectal cancer patients. It comprises 29 items, which are divided into four dimensions: lifestyle (10 items), coping/behavior restriction(9 items), depression/self-perception (7 items), and embarrassment (3 items).
Vaizey score
Time frame: From 1 month postoperatively to 12 months postoperatively
The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
Wexner score
Time frame: From 1 month postoperatively to 12 months postoperatively
The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
1 secondary outcome
Surgical complications
Time frame: From 1 month postoperatively to 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Rectum Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
Not yet recruiting
Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
Colorectal Cancer (CRC) Screening, CRC Screening
Active, not recruitingPhase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Neoplasms
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. This study is not recruiting at the moment.
Cheng-Le Zhuang, MD, PhD study chair
Shanghai Tenth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectum Cancer and Faecal Incontinence, run by Shanghai 10th People's Hospital at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
LARS score (time frame: From 1 month postoperatively to 12 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.