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Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Phase 1

Locations

Turkey

Study Type

Interventional

Intervention

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

About this trial

This is an interventional screening trial for Postoperative Pain

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Meryem Kurek EKENRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Only visceral peritoneum will be closed

Only parietal peritoneum will be closed

Both of them will be closed

None of them will be closed

Arm Description

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

Outcomes

Primary Outcome Measures

Postoperative vital sign (arterial tension)

Secondary Outcome Measures

Full Information

NCT ID

NCT02581293

First Posted

September 16, 2015

Last Updated

October 19, 2015

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02581293

Brief Title

Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

Official Title

Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Only visceral peritoneum will be closed

Arm Type

Experimental

Arm Description

Group1: Only visceral peritoneum will be closed

Arm Title

Only parietal peritoneum will be closed

Arm Type

Experimental

Arm Description

Group 2: Only parietal peritoneum will be closed

Arm Title

Both of them will be closed

Arm Type

Experimental

Arm Description

Group 3: Both of them will be closed

Arm Title

None of them will be closed

Arm Type

Experimental

Arm Description

Group 4: None of them will be closed

Intervention Type

Procedure

Intervention Name(s)

Group 1: Only visceral peritoneum will be closed

Intervention Type

Procedure

Intervention Name(s)

Group 2 : Only parietal peritoneum will be closed

Intervention Type

Procedure

Intervention Name(s)

Group 3 : Both of them will be closed

Intervention Type

Procedure

Intervention Name(s)

Group 4: None of them will be closed

Primary Outcome Measure Information:

Title

Postoperative vital sign (arterial tension)

Time Frame

First postoperative hour

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meryem Kurek EKEN, MD

Phone

+905305104468

meryemkurek@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enis Özkaya, Assoc. Prof.

Organizational Affiliation

Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meryem Kurek EKEN

City

Istanbul

State/Province

Üsküdar

ZIP/Postal Code

34280

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meryem Kurek EKEN, MD

Phone

+905305104468

meryemkurek@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

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