Viewing Study NCT03085732


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Study NCT ID: NCT03085732
Status: UNKNOWN
Last Update Posted: 2017-03-21
First Post: 2017-03-06
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Organization:

Study Overview

Official Title: The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes
Status: UNKNOWN
Status Verified Date: 2017-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: