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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Completed

Conditions: Cesarean Section

Treatments: Procedure: Bladder flap

Study type: Interventional

Funder types: Other

Identifiers

NCT02977871

1828 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

201 participants in 2 patient groups

No Bladder Flap group

No Intervention group

Description:

Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum.

Bladder Flap group

Active Comparator group

Description:

Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.

Treatment:

Procedure: Bladder flap