Condition category
Digestive System
Date applied
23/02/2007
Date assigned
02/04/2007
Last edited
30/10/2008
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 Mohammadreza Farahnak

ORCID ID

Contact details

Department of Surgery
22 Bahman Hospital
Imam street
Masjedsoleiman
19674
Iran

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This study aims to compare incorporating the Alvarado score and outpatient antibiotics with conventional clinical management in the treatment of acute appendicitis.

Ethics approval

22 Bahman Hospital ethics committee, approved on 16 May 2006. Ref: 1014/19

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Acute appendicitis

Intervention

The patients will be randomized according to a computer-generated randomization list into case and control group. The Alvarado score is calculated for both groups by a general practitioner not involved in other stages of the study. The Alvarado scores of the patients in the control group will not be known to the admitting service and surgical team. They will continue with conventional clinical assessment and management. The admitting service and the surgical team are informed of the Alvarado scores of patients in the case group. Afterward, patients of the case group will be divided into 3 management subgroups according to their own Alvarado scores: Subgroup 1 - Alvarado score 4 or less. Discharge, no follow up. Subgroup 2 - Alvarado score 5 to 7. Outpatient antibiotics and observation if practicable. They will be prescribed one dose of intravenous gentamicin, 6 mg/kg, and metronidazole, 500 mg for adults or 15 mg/kg as a loading dose for children. Afterward, patients will be discharged on a 10-day course of co-amoxiclav 625 tablets 3 times daily for adults and oral suspension of co-amoxiclav 312.5, 25 mg/kg per day in divided doses every 8 hours for children (Farabi Pharmaceutical Co, Iran). They will be asked to attend 1 day in the clinic. Subgroup 3 - Alvarado score 8 to 10. Immediate operation. They will be immediately arranged to undergo emergency surgery after intravenous injection of antibiotics loading dose as mentioned above.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Time to surgery, from randomization to skin preparation in hours
2. Duration of hospitalization, from randomization to discharge from hospital or emergency service (for out-patients) in hours

Secondary outcome measures

1. Admission rate
2. Operation rate
3. Nontherapeutic surgeries rate (surgery is called therapeutic when it finds the cause of patient’s pain and it is pertinent to cure the problem)
4. Perforation with late treatment (PLT) rate (treatment that begins at least 10 hours after randomization is considered late)

Overall trial start date

10/07/2006

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Older than 6 years
2. Admitted initially for the current abdominal pain

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

188

Participant exclusion criteria

1. Generalized peritonitis
2. Suspected of having any abdominal mass or any abdominal involvement of degenerative or systemic diseases
3. Evidence of any mental disturbances, acute confusional state, or dementia
4. Already have any imaging document including plain radiography, ultrasonography, or computed tomographic scan
5. Patients, children’s parent(s), or admitting surgeon repudiate entry into the study

Recruitment start date

10/07/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Iran

Trial participating centre

Department of Surgery, 22 Bahman Hospital
Masjedsoleiman
19674
Iran

Sponsor information

Organisation

Bahman Hospital (Iran)

Sponsor details

Department of Surgery
22 Bahman Hospital
Imam street
Masjedsoleiman
1967
Iran

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Surgery, 22 Bahman Hospital (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Surgery, Iran University of Medical Sciences (Iran)

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

2007 publication in http://www.ncbi.nlm.nih.gov/pubmed/17870498

Publication citations

  1. Publication

    Farahnak M, Talaei-Khoei M, Gorouhi F, Jalali A, Gorouhi F, The Alvarado score and antibiotics therapy as a corporate protocol versus conventional clinical management: randomized controlled pilot study of approach to acute appendicitis., Am J Emerg Med, 2007, 25, 7, 850-852, doi: 10.1016/j.ajem.2007.01.012.

Additional files

Editorial Notes