NCT03085732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

March 6, 2017

Last Update Submit

March 20, 2017

Conditions

Gynecologic Surgery

Keywords

saline irrigationabdominal hysterectomypostoperative infectious morbiditiesgastrointestinal disturbances

Outcome Measures

Primary Outcomes (1)

  • postoperative infectious morbidities

    vaginal cuff infection diagnosed with vagen cuff culture

    10 day after hysterectomy operation

Secondary Outcomes (2)

  • gastrointestinal outcomes: nausea by questionnaire

    postoperative first day

  • gastrointestinal outcome: vomiting by questionnaire

    postoperative first day

Study Arms (2)

Irrigation with saline solution

ACTIVE COMPARATOR

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

Drug: Irrigation with Saline Solution

control

NO INTERVENTION

routine abdominal hysterectomy will be performed and no abdominal saline irrigation

Interventions

Irrigation with Saline SolutionDRUG

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

Irrigation with saline solution

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing hysterectomies for benign causes

You may not qualify if:

  • patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and research hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Therapeutic IrrigationSaline Solution

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 21, 2017

Study Start

February 1, 2017

Primary Completion

May 31, 2017

Study Completion

June 30, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)