Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: Bladder flap

• Registration Number: NCT02977871
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

Cesarean section is the most common surgical procedure performed on women. Over the years minor variations of each surgical step have been introduced, and cesarean sections are not standardized and many different techniques are employed during surgery. Creation of a bladder flap has been an integral surgical step of the cesarean section for many years. The role of the bladder flap and its usefulness in cesarean section is not known well. Further, in some cases the bladder flap is omitted during cesarean section. The aim of the current study is to compare operating time and postoperative urinary symptoms in cesarean sections using either bladder flap or omission of flap.

Detailed Description

Cesarean section is the most common surgical procedure performed on women. The main aspects of the surgical approach to low-transverse cesarean delivery have not changed much since1926. Over the years minor variations of each surgical step have been introduced, and cesarean sections are not standardized and many different techniques are employed during surgery. Creation of a bladder flap has been an integral surgical step of the cesarean section for many years. The evidence on the role of the bladder flap and its usefulness in cesarean section is very limited. In emergent cesarean sections where rapid delivery is the main goal, the bladder flap is usually omitted. Literature about the usefulness of a bladder flap is limited and more randomized studies are needed. Most of the study outcomes were focusing operating time however, the investigator in the current study additional focused on postoperative urinary symptoms and dynamics. The aim of the current study is to compare operating time and postoperative urinary symptoms in cesarean sections using either bladder flap or omission of flap.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2016-10
• Status Verified: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-30
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

Inclusion Criteria

• primiparous women >37 weeks without high-risk pregnancy

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Exclusion Criteria

• presence of microbiologically confirmed urinary tract infection before delivery, twin pregnancies, cervical dilatation at admission ≥4 cm, estimated fetal weight>4000 gr, history of previous abdominal surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder Flap group	Bladder flap	Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.

Primary Outcome Measures

Name	Time	Method
Total operation time	1 hour	Total operation time from skin incision to the end of operation

Secondary Outcome Measures

Name	Time	Method
Bladder injury	up to 48 hour	Bladder injury during cesarean section will be assessed by the number and percentage of patients who had injury
Urinary retention	up to 48 hour	Postoperative urinary retention will be measured by number and percentage of patients who develop this complication
Estimated blood loss	1 hour	Estimated blood loss during surgery will be measured in terms of mL

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey