The Bladder Flap at Cesarean Section: A Randomized Controlled Trial

NCT00918996 | Completed DMC

• 1 other identifier: HRPO # 09-0173
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section

Keywords

Cesarean Section; Bladder Flap; Operating time

Outcome Measures

Primary Outcomes (1)

• Total operating time (from skin incision to closure of the skin).

  Intraoperative

Secondary Outcomes (1)

• 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.

  On first postoperative day and at 2-4 week postoperative visit

Study Arms (2)

No Bladder Flap Group

EXPERIMENTAL

Uterine incision made 1 cm above the vesico-uterine reflection without incision and dissection of the bladder peritoneum.

Procedure: Omission of Bladder Flap Creation

Bladder Flap Group

NO INTERVENTION

Standard cesarean section technique with incision and dissection of a bladder flap prior to uterine incision.

Interventions

Omission of Bladder Flap Creation PROCEDURE

Omission of bladder flap creation by making uterine incision 1 cm above the vesico-uterine reflection without incision and dissection of the bladder peritoneum.

Also known as: No Flap

No Bladder Flap Group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Emergent cesarean sections, planned vertical uterine incision, previous abdominal surgeries (besides prior cesarean sections), sedation and inability to obtain consent.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (19)

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  PMID: 22395144 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: March 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

US (1)