Prophylactic Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheter

NCT ID: NCT02879734

Last Updated: 2017-08-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mechanical Complication of Peritoneal Dialysis Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Without Omentopexy

Patients that did not undergo prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter

Group Type NO_INTERVENTION

No interventions assigned to this group

With Omentopexy

Patients that underwent prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter. Intervention = Prophylactic laparoscopic omentopexy

Group Type EXPERIMENTAL

Prophylactic laparoscopic omentopexy

Intervention Type OTHER

Fixation of omentum with sutures to anterior abdominal wall during laparoscopic surgery

Interventions

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Prophylactic laparoscopic omentopexy

Fixation of omentum with sutures to anterior abdominal wall during laparoscopic surgery

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Reza Keramati, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Mohammad Reza Keramati

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.TUMS.VCR.REC.1395.247

Identifier Type: -

Identifier Source: org_study_id

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