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OpenTrials
Completed

NCT Number: NCT00371722

Appendectomy Versus no Appendectomy With Cesarean Section

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous appendectomy

Treatment and study plan

Appendectomy

Procedure

Primary outcomes

  1. Post-operative wound infection

Secondary outcomes

  1. Post-operative fever

  2. Post-operative length of hospital stay

  3. Post-operative need for pain control

Sponsors and collaborators

Lead sponsor

Regional Obstetrical Consultants

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 4, 2006
Registry last updated
Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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