Chronic or Recurrent Appendicitis Clinical Trial
Official title:
Elective Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain; Outcome of a Prospective Randomized Double-Blind Controlled Surgical Trial
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 45 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Maxima Medical Center |
de Kok HJ. Laparoscopic appendectomy: a new opportunity for curing appendicopathy. Surg Laparosc Endosc. 1992 Dec;2(4):297-302. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary outcome: pain reduction | |||
| Primary | The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively | |||
| Secondary | Secondary outcome: histopathology | |||
| Secondary | The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices |