The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

NCT ID: NCT03085732

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Gynecologic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irrigation with saline solution

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

Group Type ACTIVE_COMPARATOR

Irrigation with Saline Solution

Intervention Type DRUG

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

control

routine abdominal hysterectomy will be performed and no abdominal saline irrigation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Irrigation with Saline Solution

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nadiye Koroglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Suleyman Training and research hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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nadiye koroglu

Role: primary

+905058065348

Other Identifiers

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Nadiye Koroglu

Identifier Type: -

Identifier Source: org_study_id

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