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

A Randomized Trial Comparing Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02977871
Enrollment
201
Registered
2016-11-30
Start date
2016-07-31
Completion date
2016-11-30
Last updated
2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Cesarean section, operating time, bladder, urinary retention

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.

Interventions

PROCEDUREBladder flap

Performing uterine incision and cesarean section with a bladder flap.

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Total operation time1 hourTotal operation time from skin incision to the end of operation

Secondary

MeasureTime frameDescription
Estimated blood loss1 hourEstimated blood loss during surgery will be measured in terms of mL
Bladder injuryup to 48 hourBladder injury during cesarean section will be assessed by the number and percentage of patients who had injury
Urinary retentionup to 48 hourPostoperative urinary retention will be measured by number and percentage of patients who develop this complication

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026