Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

March 13, 2022 updated by: Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study

Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34668
        • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cesarean section for any reasons

Exclusion Criteria:

  • Involuntary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extraperitoneal group
Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting.
Procedure: Extraperitoneal cesarean section
Active Comparator: Intraperitoneal group
Conventional transperitoneal cesarean will perform
Procedure: Intraperitoneal cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores as measured by the Visual Analog Scale
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood count
Time Frame: 2 days
2 days
C reactive proteins level
Time Frame: 2 days
2 days
Complications
Time Frame: 2 days
2 days
Discharge time
Time Frame: 4 days
4 days
Forced expiratory volume in 1 second
Time Frame: 2 days
2 days
Forced vital capacity
Time Frame: 2 days
2 days
Peak expiratory flow
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Study Director: Mehmet Baki Şentürk, MD, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

April 30, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 13, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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