Diverting IleostomyNCT04776421
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery
An observational study of Diverting Ileostomy and Middle and Low Rectal Cancer, run by The First Hospital of Jilin University.
Trial summary
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diverting Ileostomy, Middle and Low Rectal Cancer, Functional Outcome
- What is being tested?
- Diverting ileostomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Mar 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Middle and low rectal cancer patients
Who may be able to join
- Necessary conditions: meet one of the following conditions
- Difficult pelvis: narrow pelvis (diameter of ischial tuberosity <10 cm, diameter of ischial spine <12 cm) 13 or BMI≥30kg/m2 or tumor diameter≥5cm2.
- To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD
- The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc.
- Other conditions:
- Age: 18 to 75 years old, male or female;
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- Preoperative biopsy pathological diagnosis of rectal adenocarcinoma;
- Received MRI evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm;
- The clinical stage is T1-3N0-2M0;
- Undertake elective laparoscopic TME for colon-rectal or colon-anal anastomosis
- ECOG score 0-2;
- Heart, lung, liver, and kidney functions can tolerate surgery;
- Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.
Who cannot join
- Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Neighboring organs need to be combined with organ removal
- ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
- Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
- Have a history of severe mental illness;
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- Pregnant or lactating women;
- Those with a history of taking hormone drugs;
- Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.
- Conditions
- Diverting Ileostomy, Middle and Low Rectal Cancer, Functional Outcome, Stoma Complications
- Being tested
- Diverting ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diverting ileostomyProcedure or surgery
Diverting ileostomy
| Study group | Role | What they receive |
|---|---|---|
| ileostomy group | Not described Receives: Procedure: Diverting ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comprehensive complication index
comprehensive complication index, CCI
Measured: 1 year
Secondary outcomes (6)
Postoperative complications
Postoperative complications based on Clavien-Dindo
Measured: 1 year
Incidence of anastomotic leakage
Measured: 1 year
Incidence of anastomotic stenosis
Measured: 1 year
Stoma-related complications
Measured: 3 months
Complications related to ileostomy reversal
Measured: three months after ileostomy reversal
Overall Survival
Measured: three years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverting IleostomyStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
- Investigators
- Quan Wang, Prof., Principal investigator, Jilin University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776421
- Sponsor's protocol ID
- STARS-RC02
- Status last verified
- Apr 2021
- First submitted
- 24 Feb 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT04776421
- Acronym / sponsor ID
- STARS-RC02
- Conditions
- Diverting Ileostomy, Middle and Low Rectal Cancer, Functional Outcome, Stoma Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 1 Mar 2021 (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.
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ileostomy group | – | Procedure: Diverting ileostomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Middle and low rectal cancer patients
Key inclusion criteria (13 listed)
- Necessary conditions: meet one of the following conditions
- Difficult pelvis: narrow pelvis (diameter of ischial tuberosity <10 cm, diameter of ischial spine <12 cm) 13 or BMI≥30kg/m2 or tumor diameter≥5cm2.
- To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD
- The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc.
- Age: 18 to 75 years old, male or female;
Key exclusion criteria (9 listed)
- Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Neighboring organs need to be combined with organ removal
- ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
- Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying 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 |
|---|---|---|
| Diverting ileostomyDiverting ileostomy | Procedure or surgery | ileostomy group |
Primary outcome
comprehensive complication index
Time frame: 1 year
comprehensive complication index, CCI
6 secondary outcomes
Postoperative complications
Time frame: 1 year
Incidence of anastomotic leakage
Time frame: 1 year
Incidence of anastomotic stenosis
Time frame: 1 year
Stoma-related complications
Time frame: 3 months
Complications related to ileostomy reversal
Time frame: three months after ileostomy reversal
Overall Survival
Time frame: three years after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Diverting Ileostomy
Not yet recruiting
Diverting Ileostomy and Transverse Colostomy Comparative Study
Ileostomy, Colostomy
Recruiting
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
Rectal Cancer
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.
Quan Wang, Prof. principal investigator
Jilin University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Diverting Ileostomy and Middle and Low Rectal Cancer, run by The First Hospital of Jilin University.
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 13 inclusion and 9 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 8 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan Wang, Prof. (+86-431-81875602, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comprehensive complication index (time frame: 1 year). 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 8 Apr 2021.