The Bladder Flap at Cesarean Section: A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Methodius Tuuli, MD, MPH, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00918996
First received: June 9, 2009
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

Cesarean section is now the most common major surgical procedure performed on women world wide. In the United States, approximately 1 in 4 deliveries is by this method. With the increasing numbers of cesarean sections, there is the need to utilized evidence based techniques to optimize outcomes and minimize complications.Creation of the bladder flap is an integral step of the standard cesarean section. The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment. Started in the pre-antibiotic era, the rationale for the bladder flap was to enable the surgeon gain access to the lower uterine segment while minimizing injury to the bladder. Its subsequent closure was supposed to protect the peritoneal cavity from intrauterine infection. Since then, closure of the bladder flap has been demonstrated to be unnecessary and has been abandoned. The bladder flap however, continues to be performed without evidence of benefit.

Evidence on the role of the bladder flap in cesarean section is very limited. In emergent cesarean sections where rapid delivery is the goal, the bladder flap is commonly omitted. A simplified method of cesarean section (Pelosi-type) including omission of the bladder among other modifications has been shown to be safe and cost saving. The single randomized trial on omission of the bladder flap as the only modification suggests short term benefits including shorter operating times, reduced blood loss and decreased postoperative analgesic requirements. This study has been criticized for evaluating only short term outcomes and including only primary cesarean sections. The paucity of evidence for or against this commonly utilized technique in cesarean section is the rationale for this study.

The goal of this study is to employ a well designed randomized controlled clinical trial to evaluate the effects of omitting the bladder flap creation at cesarean section. We hypothesize that omission of the bladder flap in both primary and repeat cesarean sections will be associated with shorter operating time without a significant increase in intraoperative and postoperative complications.


Condition Intervention
Cesarean Section
Procedure: Omission of Bladder Flap Creation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Bladder Flap at Cesarean Delivery: Establishing Evidence for Practice

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Total operating time (from skin incision to closure of the skin). [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skin incision to delivery time, skin incision to fascial closure time, blood loss, hematuria, dysuria, urinary retention, febrile morbidity, use of analgesics, hospital days, wound infection, endomyometritis, neonatal outcomes, and readmissions. [ Time Frame: On first postoperative day and at 2-4 week postoperative visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 258
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No Bladder Flap Group
Uterine incision made 1 cm above the vesico-uterine reflection without incision and dissection of the bladder peritoneum.
Procedure: Omission of Bladder Flap Creation
Omission of bladder flap creation by making uterine incision 1 cm above the vesico-uterine reflection without incision and dissection of the bladder peritoneum.
Other Name: No Flap
No Intervention: Bladder Flap Group
Standard cesarean section technique with incision and dissection of a bladder flap prior to uterine incision.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing non-emergent primary and repeat cesarean sections at or greater than 32 weeks gestation at Barnes Jewish Hospital during the study period.

Exclusion Criteria:

  • Emergent cesarean sections, planned vertical uterine incision, previous abdominal surgeries (besides prior cesarean sections), sedation and inability to obtain consent.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00918996

Locations
United States, Missouri
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: George A. Macones, MD, MSCE Washington University School of Medicine
Principal Investigator: Methodius G. Tuuli, M.D., M.P.H. Washington University School of Medicine
Principal Investigator: Anthony Odibo, MD, MSCE Washington University School of Medicine
Principal Investigator: Patricia Fogertey, BSN, MSN Washington University Early Recognition Center
  More Information

Publications:
Hamilton, B.E., J.A. Martin, and S.J. Ventura, Births: preliminary data for 2005. Natl Vital Stat Rep, 2006. 55(11):1-18.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Methodius Tuuli, MD, MPH, Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00918996     History of Changes
Other Study ID Numbers: HRPO # 09-0173
Study First Received: June 9, 2009
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Cesarean Section
Bladder Flap
Operating time

ClinicalTrials.gov processed this record on July 20, 2014