Appendectomy Versus no Appendectomy With Cesarean Section

Cesarean Delivery Clinical Trial

Official title:

A Randomized Controlled Trial Evaluating Appendectomy at the Time of Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371722
• Other study ID #: 02-052
• Status: Completed
• Phase: N/A
• First received: August 31, 2006
• Last updated: April 19, 2007
• Start date: July 2002
• Est. completion date: May 2006

Study information

• Verified date: April 2007
• Source: Regional Obstetrical Consultants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appendectomy
• Cesarean Delivery

Intervention

Procedure:
• Appendectomy

Locations

Country	Name	City	State
United States	Erlanger Medical Center	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Regional Obstetrical Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative wound infection
Secondary	Post-operative fever
Secondary	Post-operative length of hospital stay
Secondary	Post-operative need for pain control