The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

March 20, 2017 updated by: Nadiye Koroglu, Kanuni Sultan Suleyman Training and Research Hospital

The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes

The objective of this prospective randomised clinic study is to investigate the effect of peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative infectious morbidities and gastrointestinal disturbance. The participants will be randomised to either an irrigation of abdominal cavity or the control group after vaginal closure. Assignment to one of the two treatment groups will be determined using a computer generated random numbers. Primary outcome is the rate of postoperative infectious morbidities. Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment arm planned.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Kanuni Sultan Suleyman Training and Research Hospital
        • Contact:

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients undergoing hysterectomies for benign causes

Exclusion Criteria:

  • patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Irrigation with saline solution
during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done
Drug: Irrigation with Saline Solution
During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.
No Intervention: control
routine abdominal hysterectomy will be performed and no abdominal saline irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative infectious morbidities
Time Frame: 10 day after hysterectomy operation
vaginal cuff infection diagnosed with vagen cuff culture
10 day after hysterectomy operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastrointestinal outcomes: nausea by questionnaire
Time Frame: postoperative first day
nausea by questionnaire
postoperative first day
gastrointestinal outcome: vomiting by questionnaire
Time Frame: postoperative first day
vomiting by questionnaire
postoperative first day

Collaborators and Investigators

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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

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)

February 1, 2017

Primary Completion (Anticipated)

May 31, 2017

Study Completion (Anticipated)

June 30, 2017

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nadiye Koroglu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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