Appendectomy Versus no Appendectomy With Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Delivery; Appendectomy

• Registration Number: NCT00371722
• Lead Sponsor: Regional Obstetrical Consultants

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 1.9 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 Timeline

• Study Start: 2002-07
• Study Completion: 2006-05
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-19
• Last Update Posted: 2007-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 18-45 years age
• No previous appendectomy
• Adequate pain control for cesarean section
• Able to give informed consent

Exclusion Criteria

• Previous appendectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-operative wound infection

Secondary Outcome Measures

Name	Time	Method
Post-operative need for pain control
Post-operative fever
Post-operative length of hospital stay

Trial Locations

Locations (1)

Erlanger Medical Center; 🇺🇸 Chattanooga, Tennessee, United States