| - candidate number | 2549 |
| - NTR Number | NTR955 |
| - ISRCTN | ISRCTN48831122 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 12-apr-2007 |
| - Secondary IDs | |
| - Public Title | Elective laparoscopic appendectomy for chronic right lower abdominal pain; outcome of a prospective randomised double-blind controlled surgical trial. |
| - Scientific Title | Elective laparoscopic appendectomy for chronic right lower abdominal pain. |
| - ACRONYM | N/A |
| - hypothesis | Elective laparoscopic appendectomy is a usefull procedure in patients with chronic or recurrent right lower abdominal pain. |
| - Healt Condition(s) or Problem(s) studied | Abdominal pain, Appendectomy, Laparoscopy, Chronic appendicitis, Appendicitis |
| - Inclusion criteria | 1. Between 15 and 45 years of age; 2. Suffering from chronic or recurrent right lower abdominal quadrant pain for more than three months; 3. Experience of continuous pain, or should have endured at least one pain attack in the month prior to inclusion. |
| - Exclusion criteria | 1. (A history of) Chronic back pain; 2. Previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization); 3. Specific gastro-intestinal entities (such as inflammatory bowel disease); 4. Gynaecological disease (all female patients consulted a gynaecologist). |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-1994 |
| - planned closingdate | 1-nov-2004 |
| - Target number of participants | 40 |
| - Interventions | Appendectomy by laparoscopy or not. |
| - Primary outcome | The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively in the presence of the still blinded surgical resident. |
| - Secondary outcome | The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | MH , Ph.D., M.D Rudi Roumen |
| - CONTACT for SCIENTIFIC QUERIES | MH , Ph.D., M.D Rudi Roumen |
| - Sponsor/Initiator | Maxima Medical Center, Department of General Surgery |
| - Funding (Source(s) of Monetary or Material Support) | Máxima Medical Center |
| - Publications | Br J Surg. 2008 Feb;95(2):169-74. |
| - Brief summary | Background: It is questionable whether elective appendectomy can effectively reduce pain in persistent or recurrent right lower abdominal quadrant pain due to chronic or recurrent appendicitis. Methods: A single centre randomised double-blind sham surgery controlled clinical trial studied the effects of elective laparoscopic appendectomy on postoperative pain perception in selected patients with persistent or recurrent lower abdominal quadrant pain on abdominal pain level 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. Results: 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). However, 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. |
| - Main changes (audit trail) | |
| - RECORD | 12-apr-2007 - 16-jun-2008 |
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