Cesarean Section Clinical Trial
Official title:
The Bladder Flap at Cesarean Delivery: Establishing Evidence for Practice
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.
Status | Completed |
Enrollment | 258 |
Est. completion date | September 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Barnes-Jewish Hospital | St Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Acholonu F, Minkoff H, Delke I. Percutaneous drainage of fluid collections in the bladder flap of febrile post-cesarean-section patients. A report of seven cases. J Reprod Med. 1987 Feb;32(2):140-3. — View Citation
Baker ME, Bowie JD, Killam AP. Sonography of post-cesarean-section bladder-flap hematoma. AJR Am J Roentgenol. 1985 Apr;144(4):757-9. — View Citation
Chigbu CO, Ezeome IV, Iloabachie GC. Non-formation of bladder flap at cesarean section. Int J Gynaecol Obstet. 2006 Dec;95(3):284-5. Epub 2006 Oct 23. — View Citation
Eisenkop SM, Richman R, Platt LD, Paul RH. Urinary tract injury during cesarean section. Obstet Gynecol. 1982 Nov;60(5):591-6. — View Citation
Faricy PO, Augspurger RR, Kaufman JM. Bladder injuries associated with cesarean section. J Urol. 1978 Dec;120(6):762-3. — View Citation
Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2005. Natl Vital Stat Rep. 2006 Dec 28;55(11):1-18. — View Citation
Hohlagschwandtner M, Ruecklinger E, Husslein P, Joura EA. Is the formation of a bladder flap at cesarean necessary? A randomized trial. Obstet Gynecol. 2001 Dec;98(6):1089-92. — View Citation
Honig J. Is the formation of a bladder flap at cesarean necessary? A randomized trial. Obstet Gynecol. 2002 Apr;99(4):677; author reply 677-8. — View Citation
Józwik M, Józwik M, Lotocki W, Mironczuk J. Dysuria due to bladder distortion after repeat cesarean section. Gynecol Obstet Invest. 1998;45(4):279-80. — View Citation
Lyell DJ, Caughey AB, Hu E, Daniels K. Peritoneal closure at primary cesarean delivery and adhesions. Obstet Gynecol. 2005 Aug;106(2):275-80. — View Citation
Malvasi A, Tinelli A, Tinelli R, Rahimi S, Resta L, Tinelli FG. The post-cesarean section symptomatic bladder flap hematoma: a modern reappraisal. J Matern Fetal Neonatal Med. 2007 Oct;20(10):709-14. Review. — View Citation
Nagele F, Karas H, Spitzer D, Staudach A, Karasegh S, Beck A, Husslein P. Closure or nonclosure of the visceral peritoneum at cesarean delivery. Am J Obstet Gynecol. 1996 Apr;174(4):1366-70. — View Citation
Pelosi MA 2nd, Pelosi MA 3rd. Risk factors for bladder injury during cesarean delivery. Obstet Gynecol. 2005 Apr;105(4):900; author reply 901. — View Citation
Rahman MS, Gasem T, Al Suleiman SA, Al Jama FE, Burshaid S, Rahman J. Bladder injuries during cesarean section in a University Hospital: a 25-year review. Arch Gynecol Obstet. 2009 Mar;279(3):349-52. doi: 10.1007/s00404-008-0733-1. Epub 2008 Jul 22. — View Citation
Rajasekar D, Hall M. Urinary tract injuries during obstetric intervention. Br J Obstet Gynaecol. 1997 Jun;104(6):731-4. — View Citation
Winsett MZ, Fagan CJ, Bedi DG. Sonographic demonstration of bladder-flap hematoma. J Ultrasound Med. 1986 Sep;5(9):483-7. — View Citation
Wood RM, Simon H, Oz AU. Pelosi-type vs. traditional cesarean delivery. A prospective comparison. J Reprod Med. 1999 Sep;44(9):788-95. — View Citation
Woyton J, Florjanski J, Zimmer M. [Nonclosure of the visceral peritoneum during Cesarean sections]. Ginekol Pol. 2000 Oct;71(10):1250-4. Polish. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total operating time (from skin incision to closure of the skin). | Intraoperative | No | |
Secondary | 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 | Yes |
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