Clinical trial NCT00371722: Appendectomy Versus no Appendectomy With Cesarean Section
Official title: A Randomized Controlled Trial Evaluating Appendectomy at the Time of Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery
Appendectomy
Keywords: Cesarean section
Appendectomy
Lead sponsor: Regional Obstetrical Consultants
Sponsor class: OTHER
First posted: 2006-09-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous appendectomy

Primary outcomes:
measure: Post-operative wound infection
Secondary outcomes:
measure: Post-operative fever
measure: Post-operative length of hospital stay
measure: Post-operative need for pain control
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
Study officials:
affiliation: Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
name: Charles D Adair, MD
role: PRINCIPAL_INVESTIGATOR
References: