The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

Not Applicable

• Conditions: Gynecologic Surgery
• Interventions: Drug: Irrigation with Saline Solution

• Registration Number: NCT03085732
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21
• Primary Completion: 2017-05-31
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrigation with saline solution	Irrigation with Saline Solution	during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done

Primary Outcome Measures

Name	Time	Method
postoperative infectious morbidities	10 day after hysterectomy operation	vaginal cuff infection diagnosed with vagen cuff culture

Secondary Outcome Measures

Name	Time	Method
gastrointestinal outcomes: nausea by questionnaire	postoperative first day	nausea by questionnaire
gastrointestinal outcome: vomiting by questionnaire	postoperative first day	vomiting by questionnaire

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and research hospital; 🇹🇷 Istanbul, Turkey