Gynecologic SurgeryNCT03085732
The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies
A study testing Irrigation with Saline Solution in people with Gynecologic Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- Irrigation with Saline Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing hysterectomies for benign causes
Who cannot join
- patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and research hospital
Istanbul
nadiye koroglu, +905058065348, nadiye_dugan@hotmail.com
About this study
Official title: The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes
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.
- Conditions
- Gynecologic Surgery
- Being tested
- Irrigation with Saline Solution
- Keywords
- saline irrigation, abdominal hysterectomy, postoperative infectious morbidities, gastrointestinal disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation with Saline SolutionDrug
During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation with saline solution | Active comparator | during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done Receives: Drug: Irrigation with Saline Solution |
| control | No intervention | routine abdominal hysterectomy will be performed and no abdominal saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative infectious morbidities
vaginal cuff infection diagnosed with vagen cuff culture
Measured: 10 day after hysterectomy operation
Secondary outcomes (2)
gastrointestinal outcomes: nausea by questionnaire
nausea by questionnaire
Measured: postoperative first day
gastrointestinal outcome: vomiting by questionnaire
vomiting by questionnaire
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Feb 2017
- Primary completion31 May 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadiye Koroglu, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085732
- Sponsor's protocol ID
- Nadiye Koroglu
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes
- ClinicalTrials.gov ID
- NCT03085732
- Acronym / sponsor ID
- Nadiye Koroglu
- Conditions
- Gynecologic Surgery
- Keywords
- saline irrigation, abdominal hysterectomy, postoperative infectious morbidities, gastrointestinal disturbances
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 May 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation with saline solution | Active comparator | Drug: Irrigation with Saline Solutionduring abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done |
| control | No intervention | –routine abdominal hysterectomy will be performed and no abdominal saline irrigation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing hysterectomies for benign causes
Key exclusion criteria (1 listed)
- patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation with Saline SolutionDuring hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done. | Drug | Irrigation with saline solution |
Primary outcome
postoperative infectious morbidities
Time frame: 10 day after hysterectomy operation
vaginal cuff infection diagnosed with vagen cuff culture
2 secondary outcomes
gastrointestinal outcomes: nausea by questionnaire
Time frame: postoperative first day
gastrointestinal outcome: vomiting by questionnaire
Time frame: postoperative first day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanuni Sultan Suleyman Training and research hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation with Saline Solution in people with Gynecologic Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative infectious morbidities (time frame: 10 day after hysterectomy operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.