The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

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

Sponsors

Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Source 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.

Overall Status Unknown status
Start Date February 1, 2017
Completion Date June 30, 2017
Primary Completion Date May 31, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
postoperative infectious morbidities 10 day after hysterectomy operation
Secondary Outcome
Measure Time Frame
gastrointestinal outcomes: nausea by questionnaire postoperative first day
gastrointestinal outcome: vomiting by questionnaire postoperative first day
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Irrigation with Saline Solution

Description: During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.

Arm Group Label: Irrigation with saline solution

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

Gender: Female

Gender Based: Yes

Minimum Age: 40 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Location
Facility: Status: Contact: Kanuni Sultan Suleyman Training and research hospital nadiye koroglu +905058065348 [email protected]
Location Countries

Turkey

Verification Date

March 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kanuni Sultan Suleyman Training and Research Hospital

Investigator Full Name: Nadiye Koroglu

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Irrigation with saline solution

Type: Active Comparator

Description: during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done

Label: control

Type: No Intervention

Description: routine abdominal hysterectomy will be performed and no abdominal saline irrigation

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov