Elective laparoscopic appendectomy for chronic right lower abdominal pain: outcome of a prospective randomised double-blind controlled surgical trial
| ISRCTN | ISRCTN48831122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48831122 |
| Protocol serial number | NTR955 |
| Sponsor | Maxima Medical Centre (The Netherlands) |
| Funder | Maxima Medical Centre (The Netherlands) |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 11/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rudi Roumen
Scientific
Scientific
MÁxima Medisch Centrum
Department of Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
| Phone | +31 (0)40 8888556 |
|---|---|
| r.roumen@mmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blinded, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Elective laparoscopic appendectomy for chronic right lower abdominal pain |
| Study objectives | Elective laparoscopic appendectomy is a useful procedure in patients with chronic or recurrent right lower abdominal pain. |
| Ethics approval(s) | Approval was received from the local medical ethics committee (Medisch Ethische Toetsings Commissie). The study was considered in 1993 and approved in 1994 (ref: 93-35). |
| Health condition(s) or problem(s) studied | Chronic right lower abdominal pain |
| Intervention | Appendectomy by laparoscopy or not. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome measure was pain scored by the blinded patient at six months postoperatively in the presence of the still blinded surgical resident. |
| Key secondary outcome measure(s) |
The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices. |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key 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 |
| Key exclusion criteria | 1. (A history of) chronic back pain 2. Previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilisation) 3. Specific gastro-intestinal entities (such as inflammatory bowel disease) 4. Gynaecological disease (all female patients consulted a gynaecologist) |
| Date of first enrolment | 01/09/1994 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
MÁxima Medisch Centrum
Veldhoven
5500 MB
Netherlands
5500 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2008 | Yes | No |
