The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Gynecologic Surgery

Intervention / Treatment
-----------------
* Drug: Irrigation with Saline Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Irrigation with saline solution<br>during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done | Drug: Irrigation with Saline Solution<br>* During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.<br>|
| No Intervention: control<br>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 | 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 | nausea by questionnaire | postoperative first day | 
| gastrointestinal outcome: vomiting by questionnaire | vomiting by questionnaire | postoperative first day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saline irrigation, abdominal hysterectomy, postoperative infectious morbidities, gastrointestinal disturbances