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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Dialysis Access Failure
• Intervention / Treatment: Procedure: enema

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 Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Enema group	Procedure: enema; preoperative enema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization	6 months
Catheter survival time	6 months
Incidence of peritoneal dialysis-associated Peritonitis	6 months

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: enema for PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No