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

NCT ID: NCT05258552

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Peritoneal Dialysis Access Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Enema group

Group Type EXPERIMENTAL

enema

Intervention Type PROCEDURE

preoperative enema

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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enema

preoperative enema

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Shiren sun

director of nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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enema for PD

Identifier Type: -

Identifier Source: org_study_id