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
Secondary identifying numbers NTR955
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

MÁxima Medisch Centrum
Department of Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Phone +31 (0)40 8888556
Email r.roumen@mmc.nl

Study information

Study designRandomised, double blinded, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleElective laparoscopic appendectomy for chronic right lower abdominal pain
Study objectivesElective 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) studiedChronic right lower abdominal pain
InterventionAppendectomy by laparoscopy or not.
Intervention typeOther
Primary outcome measureThe 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 measuresThe secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices.
Overall study start date01/09/1994
Completion date01/11/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants40
Key inclusion criteria1. 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 criteria1. (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 enrolment01/09/1994
Date of final enrolment01/11/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

MÁxima Medisch Centrum
Veldhoven
5500 MB
Netherlands

Sponsor information

Maxima Medical Centre (The Netherlands)
Hospital/treatment centre

Department of General Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Website http://www.mmc.nl/
ROR logo "ROR" https://ror.org/02x6rcb77

Funders

Funder type

Hospital/treatment centre

Maxima Medical Centre (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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