The Bladder Flap at Cesarean Section: A Randomized Controlled Trial
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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 |
- Total operating time (from skin incision to closure of the skin). [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
- 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 |
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| United States, Missouri | |
| Barnes-Jewish Hospital | |
| St Louis, Missouri, United States, 63110 | |
| 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 School of Medicine |
More Information
Publications:
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 May 21, 2013