The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

Kanuni Sultan Suleyman Training and Research Hospital

Status: Unknown

Conditions: Gynecologic Surgery

Treatments: Drug: Irrigation with Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03085732

Nadiye Koroglu

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Irrigation with saline solution

Active Comparator group

Description:

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

Treatment:

Drug: Irrigation with Saline Solution

control

No Intervention group

Description:

routine abdominal hysterectomy will be performed and no abdominal saline irrigation