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

Not Applicable

Not yet recruiting

• Conditions: Peritoneal Dialysis Access Failure
• Interventions: Procedure: enema

• Registration Number: NCT05258552
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2023-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enema group	enema	-

Primary Outcome Measures

Name	Time	Method
Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization	3 months
Time of first peritoneal dialysis catheter dysfunction	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of peritoneal dialysis-associated Peritonitis	6 months
Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization	6 months
Catheter survival time	6 months