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Efficacy of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis

Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05258552
Enrollment
136
Registered
2022-02-28
Start date
2022-02-28
Completion date
2024-12-31
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis Access Failure

Brief 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.

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.

Interventions

PROCEDUREenema

preoperative enema

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization3 months
Time of first peritoneal dialysis catheter dysfunction6 months

Secondary

MeasureTime frame
Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization6 months
Catheter survival time6 months
Incidence of peritoneal dialysis-associated Peritonitis6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026