Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain
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|ClinicalTrials.gov Identifier: NCT00413855|
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : December 20, 2006
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 or disease||Intervention/treatment||Phase|
|Chronic or Recurrent Appendicitis||Procedure: laparoscopic appendectomy or not (surgery)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Elective Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain; Outcome of a Prospective Randomized Double-Blind Controlled Surgical Trial|
|Study Start Date :||September 1994|
|Estimated Study Completion Date :||June 2005|
- Primary outcome: pain reduction
- The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively
- Secondary outcome: histopathology
- The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413855
|Principal Investigator:||Rudi Roumen, PhD, MD||Maxima Medical Center|