Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

NCT ID: NCT02581293

Last Updated: 2015-10-20

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

PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Only visceral peritoneum will be closed

Group1: Only visceral peritoneum will be closed

Group Type EXPERIMENTAL

Group 1: Only visceral peritoneum will be closed

Intervention Type PROCEDURE

Only parietal peritoneum will be closed

Group 2: Only parietal peritoneum will be closed

Group Type EXPERIMENTAL

Group 2 : Only parietal peritoneum will be closed

Intervention Type PROCEDURE

Both of them will be closed

Group 3: Both of them will be closed

Group Type EXPERIMENTAL

Group 3 : Both of them will be closed

Intervention Type PROCEDURE

None of them will be closed

Group 4: None of them will be closed

Group Type EXPERIMENTAL

Group 4: None of them will be closed

Intervention Type PROCEDURE

Interventions

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Group 1: Only visceral peritoneum will be closed

Intervention Type PROCEDURE

Group 2 : Only parietal peritoneum will be closed

Intervention Type PROCEDURE

Group 3 : Both of them will be closed

Intervention Type PROCEDURE

Group 4: None of them will be closed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women underwent uncomplicated c-section

Exclusion Criteria

* Patient with systemic Diseases
* Pregnant with Obstetric complications
* Pregnant with two or more previous c-sections
Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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MERYEM Kurek EKEN

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enis Özkaya, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department

Locations

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Meryem Kurek EKEN

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Meryem Kurek EKEN, MD

Role: CONTACT

+905305104468

Facility Contacts

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Meryem Kurek EKEN, MD

Role: primary

+905305104468

Other Identifiers

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31/2015

Identifier Type: -

Identifier Source: org_study_id

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