A Randomized Trial Comparing Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Total operation time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •primiparous women >37 weeks without high-risk pregnancy
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
Arms & Interventions
No Bladder Flap group
Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum.
Bladder Flap group
Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.
Intervention: Bladder flap (Procedure)
Outcomes
Primary Outcomes
Total operation time
Time Frame: 1 hour
Total operation time from skin incision to the end of operation
Secondary Outcomes
- Bladder injury(up to 48 hour)
- Urinary retention(up to 48 hour)
- Estimated blood loss(1 hour)
Investigators
Berna Aslan Cetin
Attending Physician, ObGyn
Kanuni Sultan Suleyman Training and Research Hospital