Contact information
Type
Scientific
Primary contact
Dr Rudi Roumen
ORCID ID
Contact details
MÁxima Medisch Centrum
Department of Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 8888556
r.roumen@mmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR955
Study information
Scientific title
Elective laparoscopic appendectomy for chronic right lower abdominal pain
Acronym
Study hypothesis
Elective laparoscopic appendectomy is a useful procedure in patients with chronic or recurrent right lower abdominal pain.
Ethics approval
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).
Study design
Randomised, double blinded, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic right lower abdominal pain
Intervention
Appendectomy by laparoscopy or not.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome measure was pain scored by the blinded patient at six months postoperatively in the presence of the still blinded surgical resident.
Secondary outcome measures
The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices.
Overall trial start date
01/09/1994
Overall trial end date
01/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant 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)
Recruitment start date
01/09/1994
Recruitment end date
01/11/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
MÁxima Medisch Centrum
Veldhoven
5500 MB
Netherlands
Sponsor information
Organisation
Maxima Medical Centre (The Netherlands)
Sponsor details
Department of General Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Maxima Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18161760
Publication citations
-
Results
Roumen RM, Groenendijk RP, Sloots CE, Duthoi KE, Scheltinga MR, Bruijninckx CM, Randomized clinical trial evaluating elective laparoscopic appendicectomy for chronic right lower-quadrant pain., Br J Surg, 2008, 95, 2, 169-174, doi: 10.1002/bjs.6026.