The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

Gynecologic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085732
• Other study ID #: Nadiye Koroglu
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2017
• Last updated: March 20, 2017
• Start date: February 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2017
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Surgery

Intervention

Drug:
• Irrigation with Saline Solution
During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative infectious morbidities	vaginal cuff infection diagnosed with vagen cuff culture	10 day after hysterectomy operation
Secondary	gastrointestinal outcomes: nausea by questionnaire	nausea by questionnaire	postoperative first day
Secondary	gastrointestinal outcome: vomiting by questionnaire	vomiting by questionnaire	postoperative first day