Should we remove a normal-looking appendix at a diagnostic laparoscopy in patients with acute right iliac fossa pain and no other detectable pathology?
| ISRCTN | ISRCTN06195808 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06195808 |
| Protocol serial number | N0453122643 |
| Sponsor | Department of Health (UK) |
| Funder | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Basil Ammori
Scientific
Scientific
Central Manchester & Manchester Children's University Hospitals MRI
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Appendectomy |
| Intervention | Randomised controlled trial comparing laprascopic removal of normal looking appendix with non-removal on diagnosis of appendicitis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Number of patients readmitted with right lower abdominal pain during a follow up period of 12 months. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key inclusion criteria | Adult subjects aged >18 years who present and are admitted to hospital acutely with right lower abdominal pain and are suspected to have acute appendicitis for which a diagnostic laparoscopy is contemplated will be considered for the study, and consented. Patients who were consented and in whom no detectable pathology is found at the time of diagnostic laparoscopy will be randomised in theatre. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 06/01/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Central Manchester & Manchester Children's University Hospitals MRI
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
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 | 01/10/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |