NCT05258552

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

February 9, 2022

Last Update Submit

February 17, 2022

Conditions

Peritoneal Dialysis Access Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Enema group

EXPERIMENTAL
Procedure: enema

Control group

NO INTERVENTION

Interventions

enemaPROCEDURE

preoperative enema

Enema group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Enema

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of nephrology

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 28, 2022

Study Start

February 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2024

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share