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Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

Primary Purpose

Postpartum Fever, Ileus, Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extraperitoneal cesarean section
Intraperitoneal cesarean section
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Fever focused on measuring Forced Expiratory Volume in 1 second, Forced expiratory vital capacity, Peak expiratory flow

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Cesarean section for any reasons

Exclusion Criteria:

  • Involuntary

Sites / Locations

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extraperitoneal group

Intraperitoneal group

Arm Description

Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting.

Conventional transperitoneal cesarean will perform

Outcomes

Primary Outcome Measures

Pain Scores as measured by the Visual Analog Scale

Secondary Outcome Measures

Blood count
C reactive proteins level
Complications
Discharge time
Forced expiratory volume in 1 second
Forced vital capacity
Peak expiratory flow

Full Information

First Posted
March 14, 2016
Last Updated
March 13, 2022
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02760290
Brief Title
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique
Official Title
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Fever, Ileus, Hemorrhage, Pain
Keywords
Forced Expiratory Volume in 1 second, Forced expiratory vital capacity, Peak expiratory flow

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extraperitoneal group
Arm Type
Experimental
Arm Description
Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting.
Arm Title
Intraperitoneal group
Arm Type
Active Comparator
Arm Description
Conventional transperitoneal cesarean will perform
Intervention Type
Procedure
Intervention Name(s)
Extraperitoneal cesarean section
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal cesarean section
Primary Outcome Measure Information:
Title
Pain Scores as measured by the Visual Analog Scale
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Blood count
Time Frame
2 days
Title
C reactive proteins level
Time Frame
2 days
Title
Complications
Time Frame
2 days
Title
Discharge time
Time Frame
4 days
Title
Forced expiratory volume in 1 second
Time Frame
2 days
Title
Forced vital capacity
Time Frame
2 days
Title
Peak expiratory flow
Time Frame
2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cesarean section for any reasons Exclusion Criteria: Involuntary
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Baki Şentürk, MD
Organizational Affiliation
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
City
İstanbul
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23727518
Citation
Tappauf C, Schest E, Reif P, Lang U, Tamussino K, Schoell W. Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity. Am J Obstet Gynecol. 2013 Oct;209(4):338.e1-8. doi: 10.1016/j.ajog.2013.05.057. Epub 2013 May 30.
Results Reference
result
PubMed Identifier
18194912
Citation
Chou CY, Liang PC, Chen CA, Lee CN. Cervical abscess with vaginal fistula after extraperitoneal Cesarean section. J Formos Med Assoc. 2007 Dec;106(12):1048-51. doi: 10.1016/S0929-6646(08)60082-0.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23727518
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/18194912
Description
Related Info

Learn more about this trial

Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

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