Peritoneal Dialysis Access FailureNCT05258552
Efficacy of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis
A study testing enema in people with Peritoneal Dialysis Access Failure, run by Air Force Military Medical University, China.
Trial summary
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Access Failure
- What is being tested?
- enema
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18;
- Maintenance peritoneal dialysis treatment is required for end-stage Renal Disease;
- First-time open surgeon peritoneal dialysis catheterization patient;
- Only straight double-cuff Tenckhoff dialysis catheters were used.
- Willing to participate in this study and sign informed consent form.
Who cannot join
- peritoneal dialysis contraindication;
- Enema contraindication;
- Patients refuse enema;
- Expected survival time < 3 months;
- Catharsis such as Senna Leaf and lactulose used before operation or colonic dialysis and enema used 3 days before operation.
About this study
Official title: Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction.
Read the detailed description
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. All the patients were divided into two groups: preoperative enema group and no intervention group. The peritoneal dialysis malfuction were observed.
- Conditions
- Peritoneal Dialysis Access Failure
- Being tested
- enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enemaProcedure or surgery
preoperative enema
| Study group | Role | What they receive |
|---|---|---|
| Enema group | Experimental | Not described Receives: Procedure: enema |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization
Measured: 3 months
Time of first peritoneal dialysis catheter dysfunction
Measured: 6 months
Secondary outcomes (3)
Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization
Measured: 6 months
Catheter survival time
Measured: 6 months
Incidence of peritoneal dialysis-associated Peritonitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis Access FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258552
- Sponsor's protocol ID
- enema for PD
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study
- ClinicalTrials.gov ID
- NCT05258552
- Acronym / sponsor ID
- enema for PD
- Conditions
- Peritoneal Dialysis Access Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 2022 (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.
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction.
Detailed description
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. All the patients were divided into two groups: preoperative enema group and no intervention group. The peritoneal dialysis malfuction were observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enema group | Experimental | Procedure: enema |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18;
- Maintenance peritoneal dialysis treatment is required for end-stage Renal Disease;
- First-time open surgeon peritoneal dialysis catheterization patient;
- Only straight double-cuff Tenckhoff dialysis catheters were used.
- Willing to participate in this study and sign informed consent form.
Key exclusion criteria (5 listed)
- peritoneal dialysis contraindication;
- Enema contraindication;
- Patients refuse enema;
- Expected survival time < 3 months;
- Catharsis such as Senna Leaf and lactulose used before operation or colonic dialysis and enema used 3 days before operation.
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 |
|---|---|---|
| enemapreoperative enema | Procedure or surgery | Enema group |
Primary outcome
Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization
Time frame: 3 months
Time of first peritoneal dialysis catheter dysfunction
Time frame: 6 months
3 secondary outcomes
Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization
Time frame: 6 months
Catheter survival time
Time frame: 6 months
Incidence of peritoneal dialysis-associated Peritonitis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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.
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 enema in people with Peritoneal Dialysis Access Failure, run by Air Force Military Medical University, 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 5 inclusion and 5 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 28 Feb 2022. 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?
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?
Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization (time frame: 3 months). The study lists 2 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 28 Feb 2022.