Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371722
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2006-08-31
Brief Title:
Appendectomy Versus no Appendectomy With Cesarean Section
Sponsor:
Regional Obstetrical Consultants
Organization:
Regional Obstetrical Consultants
Study Overview
Official Title:
A Randomized Controlled Trial Evaluating Appendectomy at the Time of Cesarean Section
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
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:
Women having cesarean section will be divided into two groups - cesarean section alone or cesarean section with appendectomy The purpose is to see if the appendectomy can be done without adding any complications to the maternal post-operative course The hypothesis is that there is no increased incidence of wound infection post-operative morbidity or longer hospital stay associated with elective appendectomy at the time of Cesarean Section
Detailed Description:
Even though the incidence of appendicitis has decreased significantly since the advent of antibiotics the disease process is still quite ubiquitous in many patient populations The incidence of appendicitis in women over 20 and under 50 years of age is significant The annual incidence of appendicitis in women aged 17 to 64 years of age is 19 per 1000 In the population aged 15 to 19 years of age the risk of developing appendicitis is 1 in 99 in each year of this 4-year period Diagnosing appendicitis in pregnancy poses a great challenge for the obstetrician because the appendix is displaced during pregnancy nausea is common in pregnancy direct abdominal signs are variable as well The incidence of proven appendicitis approximates 1 in 1500 deliveries Maternal and fetal mortality and morbidity are increased when appendicitis is associated with pregnancy and the risks rise significantly if perforation and peritonitis occur Fetal loss which is between 10 and 20 in most reports is mainly due to preterm labor or intrauterine death particularly when perforation occurs There are three main reasons to perform an incidental appendectomy at the time of cesarean section To reduce future mortality and morbidity from appendicitis in women of childbearing age to eliminate undiagnosed incidental pathology in the appendix and to eliminate the appendix from diagnostic consideration when the patient presents with abdominal or pelvic complaints There will be 100 subjects taking part in the study Standard post operative care will be administered with the only difference in the two groups being the operative procedure appendectomy or no appendectomy
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