Postoperative PainPhase 1NCT02581293
Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs
A Phase 1 study testing Group 1: Only visceral peritoneum will be closed, Group 2 : Only parietal peritoneum will be closed and Group 3 : Both of them will be closed in people with Postoperative Pain, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum. Read more about this study
- Who is it for?
- Ages Up to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Group 1: Only visceral peritoneum will be closed, Group 2 : Only parietal peritoneum will be closed and Group 3 : Both of them will be closed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Feb 2016
- Phase
- Phase 1
- 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 Up to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women underwent uncomplicated c-section
Who cannot join
- Patient with systemic Diseases
- Pregnant with Obstetric complications
- Pregnant with two or more previous c-sections
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Meryem Kurek EKEN
Istanbul, Üsküdar, 34280
Meryem Kurek EKEN, MD, +905305104468, meryemkurek@yahoo.com
About this study
In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.
Read the detailed description
At c-section subject will be randomised into four groups:
Group1: Only visceral peritoneum will be closed
Group 2: Only parietal peritoneum will be closed
Group 3: Both of them will be closed
Group 4: None of them will be closed
During the postoperative period all patients will undergo vital sign screening including urine output, blood pressure measurement, pulse rate and VAS score will be determined at post operative 6th hour and 24th hour.
- Conditions
- Postoperative Pain
- Being tested
- Group 1: Only visceral peritoneum will be closed, Group 2 : Only parietal peritoneum will be closed, Group 3 : Both of them will be closed, Group 4: None of them will be closed
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Only visceral peritoneum will be closedProcedure or surgery
Group 2 : Only parietal peritoneum will be closedProcedure or surgery
Group 3 : Both of them will be closedProcedure or surgery
Group 4: None of them will be closedProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Only visceral peritoneum will be closed | Experimental | Group1: Only visceral peritoneum will be closed Receives: Procedure: Group 1: Only visceral peritoneum will be closed |
| Only parietal peritoneum will be closed | Experimental | Group 2: Only parietal peritoneum will be closed Receives: Procedure: Group 2 : Only parietal peritoneum will be closed |
| Both of them will be closed | Experimental | Group 3: Both of them will be closed Receives: Procedure: Group 3 : Both of them will be closed |
| None of them will be closed | Experimental | Group 4: None of them will be closed Receives: Procedure: Group 4: None of them will be closed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative vital sign (arterial tension)
Measured: First postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERYEM Kurek EKEN, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Enis Özkaya, Assoc. Prof., Principal investigator, Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581293
- Sponsor's protocol ID
- 31/2015
- Status last verified
- Oct 2015
- First submitted
- 16 Sep 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs
- ClinicalTrials.gov ID
- NCT02581293
- Acronym / sponsor ID
- 31/2015
- Conditions
- Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (estimated)
- First posted
- 20 Oct 2015 (estimated)
- 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.
In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.
Detailed description
At c-section subject will be randomised into four groups:
Group1: Only visceral peritoneum will be closed
Group 2: Only parietal peritoneum will be closed
Group 3: Both of them will be closed
Group 4: None of them will be closed
During the postoperative period all patients will undergo vital sign screening including urine output, blood pressure measurement, pulse rate and VAS score will be determined at post operative 6th hour and 24th hour.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Only visceral peritoneum will be closed | Experimental | Procedure: Group 1: Only visceral peritoneum will be closedGroup1: Only visceral peritoneum will be closed |
| Only parietal peritoneum will be closed | Experimental | Procedure: Group 2 : Only parietal peritoneum will be closedGroup 2: Only parietal peritoneum will be closed |
| Both of them will be closed | Experimental | Procedure: Group 3 : Both of them will be closedGroup 3: Both of them will be closed |
| None of them will be closed | Experimental | Procedure: Group 4: None of them will be closedGroup 4: None of them will be closed |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women underwent uncomplicated c-section
Key exclusion criteria (3 listed)
- Patient with systemic Diseases
- Pregnant with Obstetric complications
- Pregnant with two or more previous c-sections
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 |
|---|---|---|
| Group 1: Only visceral peritoneum will be closed | Procedure or surgery | Only visceral peritoneum will be closed |
| Group 2 : Only parietal peritoneum will be closed | Procedure or surgery | Only parietal peritoneum will be closed |
| Group 3 : Both of them will be closed | Procedure or surgery | Both of them will be closed |
| Group 4: None of them will be closed | Procedure or surgery | None of them will be closed |
Primary outcome
Postoperative vital sign (arterial tension)
Time frame: First postoperative hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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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.
Enis Özkaya, Assoc. Prof. principal investigator
Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group 1: Only visceral peritoneum will be closed, Group 2 : Only parietal peritoneum will be closed and Group 3 : Both of them will be closed in people with Postoperative Pain, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 3 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 20 Oct 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Meryem Kurek EKEN, MD (+905305104468, meryemkurek@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative vital sign (arterial tension) (time frame: First postoperative hour). 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 20 Oct 2015.