Appendectomy Versus no Appendectomy With Cesarean Section

This study has been completed.
Sponsor:
Information provided by:
Regional Obstetrical Consultants
ClinicalTrials.gov Identifier:
NCT00371722
First received: August 31, 2006
Last updated: April 19, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention
Cesarean Delivery
Appendectomy
Procedure: Appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Evaluating Appendectomy at the Time of Cesarean Section

Resource links provided by NLM:


Further study details as provided by Regional Obstetrical Consultants:

Primary Outcome Measures:
  • Post-operative wound infection

Secondary Outcome Measures:
  • Post-operative fever
  • Post-operative length of hospital stay
  • Post-operative need for pain control

Estimated Enrollment: 100
Study Start Date: July 2002
Study Completion Date: May 2006
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371722

Locations
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Regional Obstetrical Consultants
Investigators
Principal Investigator: Charles D Adair, MD Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00371722     History of Changes
Other Study ID Numbers: 02-052
Study First Received: August 31, 2006
Last Updated: April 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Regional Obstetrical Consultants:
Cesarean section
Appendectomy

ClinicalTrials.gov processed this record on July 20, 2014