Prophylactic Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheter

August 6, 2017 updated by: Tehran University of Medical Sciences

Comparison Between Performing Prophylactic Omentopexy and Lack of Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheters in Terms of Complications and Catheter Function

The purpose of this study is to compare function of the peritoneal dialysis catheter in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peritoneal dialysis is a know and accepted treatment in patients with end stage renal diseases. The is a safe, easy and cheap treatment modality in these patients. After introduction and development of laparoscopic procedures for insertion of peritoneal dialysis catheters, some prophylactic surgical techniques have been proposed as measures to reduce catheter malfunction. Omentopexy is among these techniques. The purpose of this study is to compare function of the peritoneal dialysis catheter (including inflow and outflow failure) in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• End-stage renal failure in need of prolonged dialysis referred for insertion of peritoneal dialysis catheter

Exclusion Criteria:

  • Contraindications to laparoscopic surgery
  • Coagulative disorder
  • Death of participant due to other reasons before usage of peritoneal catheter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Without Omentopexy
Patients that did not undergo prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter
Experimental: With Omentopexy
Patients that underwent prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter. Intervention = Prophylactic laparoscopic omentopexy
Other: Prophylactic laparoscopic omentopexy
Fixation of omentum with sutures to anterior abdominal wall during laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of the peritoneal catheter to pass the dialysis fluid
Time Frame: One months
Inflow and outflow passage of the peritoneal dialysis fluid from the catheter based on questionnaire
One months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Reza Keramati, M.D., Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 6, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IR.TUMS.VCR.REC.1395.247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mechanical Complication of Peritoneal Dialysis Catheter

Clinical Trials on Prophylactic laparoscopic omentopexy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe