NCT00413855

Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

Elective Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain; Outcome of a Prospective Randomized Double-Blind Controlled Surgical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Maxima Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Chronic or Recurrent Appendicitis

Interventions

Type	Name	Description
PROCEDURE	laparoscopic appendectomy or not (surgery)

Timeline

• Start date: 1994-09-01
• Completion: 2005-06-01
• First posted: 2006-12-20
• Last updated: 2006-12-20