Extraperitoneal Versus Transperitoneal Cesarean Section

Extraperitoneal Versus Transperitoneal Cesarean Section: A Prospective Randomized Comparison

The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean, Extraperitoneal
• Intervention / Treatment: Procedure: Transperitoneal Cesarean; Procedure: Extraperitoneal Cesarean

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Ataturk University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• elective cesarean (primary or repeated up to four)

Exclusion Criteria:

• emergent cesarean
• macrosomia (fetal weight > 4500 g)
• history of major abdominal surgery
• suspected abnormal placentation
• placenta previa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transperitoneal Cesarean	Procedure: Transperitoneal Cesarean; Pfannenstiel-Kerr technique for laparatomy and uterine entry
Active Comparator: Extraperitoneal Cesarean	Procedure: Extraperitoneal Cesarean; Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	Perceived pain scores will be measured by an visual analog scale.	One hour before cesarean and 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delivery time	skin incision to delivery	2 minutes after delivery
operation time	skin incision to skin closure	5 minutes postoperatively
hemoglobin differences		one hour before cesarean, 48 hour postoperatively
need for extra analgesic		48 hour
nausea		48 hour
vomiting		48 hour
thoracic and shoulder pain		48 hour
Urogenital distress measured by Urogenital Distress Inventory		One hour before cesarean and 24 hour postoperatively
Oral intake	The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hour after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.	48 hour

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 5, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Cesarean; Cesarean, extraperitoneal
• Other Study ID Numbers: atauni8