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OpenTrials
Completed

NCT Number: NCT00413855

Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

laparoscopic appendectomy or not (surgery)

Procedure

Primary outcomes

  1. Primary outcome: pain reduction

  2. The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively

Secondary outcomes

  1. Secondary outcome: histopathology

  2. The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices

Sponsors and collaborators

Lead sponsor

Maxima Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
1994
Study completion
2005
First posted
Dec 20, 2006
Registry last updated
Dec 20, 2006

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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