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

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05258552
Collaborator
(none)
136
Enrollment
2
Arms
34
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: enema
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Enema group

Procedure: enema
preoperative enema
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization [3 months]

  2. Time of first peritoneal dialysis catheter dysfunction [6 months]

Secondary Outcome Measures

  1. Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization [6 months]

  2. Catheter survival time [6 months]

  3. Incidence of peritoneal dialysis-associated Peritonitis [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Air Force Military Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shiren sun, director of nephrology, Air Force Military Medical University, China
ClinicalTrials.gov Identifier:
NCT05258552
Other Study ID Numbers:
  • enema for PD
First Posted:
Feb 28, 2022
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 28, 2022