Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470288
Status:
UNKNOWN
Last Update Posted:
2007-05-07
First Post:
2007-05-04
Brief Title:
Randomized Controlled Trial of Bladder Flap vsNone
Sponsor:
Mountain Area Health Organization Center
Organization:
Mountain Area Health Organization Center
Study Overview
Official Title:
Randomized Controlled Trial of Bladder Flap vsNone
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To compare outcomes in cesarean section patients undergoing bladder flap versus none Hypotheses Operative time will be reduced with the elimination of a bladder flap during cesarean delivery and intra-operative and post-operative morbidity will not be significantly different
Patients 35 wks gestation undergoing cesarean delivery will be randomized to bladder flap vs none Primary outcome is operative time start to delivery secondary outcomes include injuries EBL intra-operative and post-operative complicationspain medication hospital stay duration
Patients 35 wks gestation undergoing cesarean delivery will be randomized to bladder flap vs none Primary outcome is operative time start to delivery secondary outcomes include injuries EBL intra-operative and post-operative complicationspain medication hospital stay duration
Detailed Description:
1 Title A Randomized Controlled Trial of Bladder Flap vs None in Cesarean Section
2 Background This section should be used to provide a rationale for the conduct of the study Refer to existent or preliminary studies as necessary The standard of care in performing cesarean delivery is to perform a bladder flap in the procedures1 The creation of a bladder flap essentially allows a surgeon to create a space between the uterus and the bladder so that heshe has better access to the lower portion of the uterus where a low transverse incision can be made This procedure involves making a superficial incision into the peritoneum or the cell lining of the abdominal cavity and the moving the bladder down and away from the lower portion of the uterus A retractor or a bladder blade is then inserted into this space to hold the bladder away from the uterus see Appendix A2 Use of the bladder flap in cesarean delivery dates back to 1878 in the pre-antibiotic era3 and theoretically the bladder flap allows better access to the low portion of the uterus while decreasing risk of bladder injury and infection However several recent but small studies suggest the inclusion of the bladder flap confers no advantage and may actually contribute to greater morbidity postoperatively 4-5 Additionally the incidence of bladder injuries is 03 and most injuries resulted during the formation of the bladder flap6 The evidence from these studies are limited by the inclusion of other modifications in surgical procedures and a lack of replication of results respectively Thus there is insufficient evidence to either support or reject the inclusion of bladder flaps in cesarean deliveries Evidence grade C7-8
3 Specific Objectives Enumerate the objectives and nature of the measured end-points Justify the use of surrogate clinical end-points as necessary
1 To compare outcomes in cesarean section patients undergoing bladder flap versus none
4 Study design Explicate the nature of the study - observational vs experimental Differentiate between cohort case-control and cross-sectional and randomized clinical trials For the latter provide sufficient supporting justification for the experimental arm If it is a placebo-controlled trial please state whether clinical equipoise exists between the placebo and experimental arm Randomized controlled trial
Endpoints
Total operating time continuous and Time of delivery to end of surgery continuous Estimated blood loss continuous Post operative fever categorical Bladder injury categorical Pre- and post-operative pain medication continuous and Analog pain scale continuous
5 Subject Selection Include an enumeration of inclusion and exclusion criteria
MAHEC patients presenting for delivery at Mission Hospitals requiring a cesarean section
Inclusion Exclusion Cesarean section All vaginal deliveries
35 weeks gestation 35 weeks gestation Able to provide consent for medical treatment Urgent cesarean section Unable to provide consent for medical treatment Medical complications prohibitive of bladder flap Medical complications prohibitive of no bladder flap
6 Statistical methods data analysis and interpretation Include the factors considered in determining an appropriate sample size Sample size of 100 per group based on an estimated mean difference of 5 minutes on total operating time study arm 45125 vs bladder flap arm 50125 Power080 alpha005 two-tailed4
Per protocol analysis utilizing analysis of variance or for continuous variables and chi square analysis of categorical variables
7 Study Procedures Describe the chronological flow of the study using schematic diagrams as necessary Distinguish clearly between treatment-related medically-indicated and research-related procedures the subject will undergo
All OB patients presenting at LD for delivery will be approached for informed consent consenting patients for whom a cesarean delivery is medically indicated will be randomized to bladder flap vs none Patients unable to consent for medical treatment or not wishing to consent for the project will be excluded Consenting patients for whom a cesarean is medically indicated will be randomly assigned to bladder flap vs by previously allocation of subject number Patients will undergo assigned procedure unless excluded at the discretion of the surgeons who determine the alternate procedure is medically indicated Patients undergoing the assigned procedure will have all data extracted from hospital medical records and entered into SPSS for a per-protocol analysis
2 Background This section should be used to provide a rationale for the conduct of the study Refer to existent or preliminary studies as necessary The standard of care in performing cesarean delivery is to perform a bladder flap in the procedures1 The creation of a bladder flap essentially allows a surgeon to create a space between the uterus and the bladder so that heshe has better access to the lower portion of the uterus where a low transverse incision can be made This procedure involves making a superficial incision into the peritoneum or the cell lining of the abdominal cavity and the moving the bladder down and away from the lower portion of the uterus A retractor or a bladder blade is then inserted into this space to hold the bladder away from the uterus see Appendix A2 Use of the bladder flap in cesarean delivery dates back to 1878 in the pre-antibiotic era3 and theoretically the bladder flap allows better access to the low portion of the uterus while decreasing risk of bladder injury and infection However several recent but small studies suggest the inclusion of the bladder flap confers no advantage and may actually contribute to greater morbidity postoperatively 4-5 Additionally the incidence of bladder injuries is 03 and most injuries resulted during the formation of the bladder flap6 The evidence from these studies are limited by the inclusion of other modifications in surgical procedures and a lack of replication of results respectively Thus there is insufficient evidence to either support or reject the inclusion of bladder flaps in cesarean deliveries Evidence grade C7-8
3 Specific Objectives Enumerate the objectives and nature of the measured end-points Justify the use of surrogate clinical end-points as necessary
1 To compare outcomes in cesarean section patients undergoing bladder flap versus none
4 Study design Explicate the nature of the study - observational vs experimental Differentiate between cohort case-control and cross-sectional and randomized clinical trials For the latter provide sufficient supporting justification for the experimental arm If it is a placebo-controlled trial please state whether clinical equipoise exists between the placebo and experimental arm Randomized controlled trial
Endpoints
Total operating time continuous and Time of delivery to end of surgery continuous Estimated blood loss continuous Post operative fever categorical Bladder injury categorical Pre- and post-operative pain medication continuous and Analog pain scale continuous
5 Subject Selection Include an enumeration of inclusion and exclusion criteria
MAHEC patients presenting for delivery at Mission Hospitals requiring a cesarean section
Inclusion Exclusion Cesarean section All vaginal deliveries
35 weeks gestation 35 weeks gestation Able to provide consent for medical treatment Urgent cesarean section Unable to provide consent for medical treatment Medical complications prohibitive of bladder flap Medical complications prohibitive of no bladder flap
6 Statistical methods data analysis and interpretation Include the factors considered in determining an appropriate sample size Sample size of 100 per group based on an estimated mean difference of 5 minutes on total operating time study arm 45125 vs bladder flap arm 50125 Power080 alpha005 two-tailed4
Per protocol analysis utilizing analysis of variance or for continuous variables and chi square analysis of categorical variables
7 Study Procedures Describe the chronological flow of the study using schematic diagrams as necessary Distinguish clearly between treatment-related medically-indicated and research-related procedures the subject will undergo
All OB patients presenting at LD for delivery will be approached for informed consent consenting patients for whom a cesarean delivery is medically indicated will be randomized to bladder flap vs none Patients unable to consent for medical treatment or not wishing to consent for the project will be excluded Consenting patients for whom a cesarean is medically indicated will be randomly assigned to bladder flap vs by previously allocation of subject number Patients will undergo assigned procedure unless excluded at the discretion of the surgeons who determine the alternate procedure is medically indicated Patients undergoing the assigned procedure will have all data extracted from hospital medical records and entered into SPSS for a per-protocol analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None