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Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

Z

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status and phase

Unknown
Phase 1

Conditions

Postoperative Pain

Treatments

Procedure: Group 4: None of them will be closed
Procedure: Group 1: Only visceral peritoneum will be closed
Procedure: Group 2 : Only parietal peritoneum will be closed
Procedure: Group 3 : Both of them will be closed

Study type

Interventional

Funder types

Other

Identifiers

NCT02581293
31/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 estimated patients

Sex

Female

Ages

Under 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

132 participants in 4 patient groups

Only visceral peritoneum will be closed
Experimental group
Description:
Group1: Only visceral peritoneum will be closed
Treatment:
Procedure: Group 1: Only visceral peritoneum will be closed
Only parietal peritoneum will be closed
Experimental group
Description:
Group 2: Only parietal peritoneum will be closed
Treatment:
Procedure: Group 2 : Only parietal peritoneum will be closed
Both of them will be closed
Experimental group
Description:
Group 3: Both of them will be closed
Treatment:
Procedure: Group 3 : Both of them will be closed
None of them will be closed
Experimental group
Description:
Group 4: None of them will be closed
Treatment:
Procedure: Group 4: None of them will be closed

Trial contacts and locations

1

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Central trial contact

Meryem Kurek EKEN, MD

Data sourced from clinicaltrials.gov

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