Condition category
Signs and Symptoms
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mmc.nl/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18161760

Publication citations

  1. 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.

Additional files

Editorial Notes