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

Peritoneal Dialysis Access Failure Clinical Trial

Official title:

Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05258552
• Other study ID #: enema for PD
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peritoneal Dialysis Access Failure

Intervention

Procedure:
• enema
preoperative enema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization		3 months
Primary	Time of first peritoneal dialysis catheter dysfunction		6 months
Secondary	Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization		6 months
Secondary	Catheter survival time		6 months
Secondary	Incidence of peritoneal dialysis-associated Peritonitis		6 months