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Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

This study has been completed.
Sponsor:
Information provided by:
Maxima Medical Center
ClinicalTrials.gov Identifier:
NCT00413855
First received: December 19, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

It is questionable whether elective appendectomy can effectively reduce pain in persistent or recurrent lower abdominal quadrant pain due to chronic appendicitis.

A single centre randomised double-blind sham surgery controlled clinical trial studied the effects of elective laparoscopic appendectomy on postoperative pain perception in patients with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months postoperatively. Secondary outcome was the relation between clinical response and the appendix’ histopathology. The analysis was performed on an intention-to-treat basis. Pain scores were compared using a Fisher’s exact test.


Condition Intervention Phase
Chronic or Recurrent Appendicitis
 Procedure: laparoscopic appendectomy or not (surgery)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Elective Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain; Outcome of a Prospective Randomized Double-Blind Controlled Surgical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maxima Medical Center:

Primary Outcome Measures:
  • Primary outcome: pain reduction
  • The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively

Secondary Outcome Measures:
  • Secondary outcome: histopathology
  • The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices

Estimated Enrollment: 40
Study Start Date: September 1994
Estimated Study Completion Date: June 2005
Detailed Description:

Forty patients were randomised, 18 patients had a laparoscopic appendectomy and 22 patients had a laparoscopic inspection only. The postoperative pain scores were significantly different favouring appendix removal (p < 0.01). Relative risk calculations indicated a 2.4 fold (95% CI: 1.3 – 4.0) greater chance of improving or becoming pain free after laparoscopic appendectomy. The number needed to treat was 2.2 patients (95% CI: 1.5 – 6.5). There was no significant relation between postoperative pain scores and histopathology findings.

Conclusions Chronic or recurrent appendicitis is a realistic clinical entity that can be treated successfully by elective appendectomy leading to significant pain reduction in properly selected cases. Histopathology of the removed appendix does not contribute to the diagnosis.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion.

Exclusion Criteria:

  • Exclusion criteria consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, exclusion was possible when diagnostic laparoscopy revealed abnormalities (see below).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413855

Sponsors and Collaborators
Maxima Medical Center
Investigators
Principal Investigator: Rudi Roumen, PhD, MD Maxima Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00413855     History of Changes
Other Study ID Numbers: 9335
Study First Received: December 19, 2006
Last Updated: December 19, 2006
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maxima Medical Center:
Abdominal pain
Appendectomy
Laparoscopy
Chronic appendicitis
Appendicopathy

Additional relevant MeSH terms:
Abdominal Pain
Appendicitis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 19, 2013