Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

NCT02916134 | Completed

• 1 other identifier: 16/59
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Successful treatment of appendicitis

  Successful treatment is defined as the resolution of appendicitis resulting in discharge from the hospital and no recurrent appendicitis during the one-year follow-up. The number of patients requiring surgery for appendicitis in the non-operative group will be measured.

  1 year post enrollment

Secondary Outcomes (6)

• Recurrence of appendicitis

  1 year post enrollment

• Clostridium difficile infection

  1 year post enrollment

• Need for re-admission or repeat imaging

  1 year post enrollment

• Quality of life Questionnaire taken over the year after recruitment

  1 year post enrollment

• Complication of treatment

  1 year post enrollment

Study Arms (2)

Operative Intervention

ACTIVE COMPARATOR

Laparoscopic +/- open appendicectomy, with antibiotics at induction and 3 further doses of intravenous antibiotics. Co-amoxiclav, or cefuroxime and metronidazole if previous rash-allergy to penicillin.

Procedure: Laparoscopic +/- Open Appendicectomy

Antibiotic Treatment

EXPERIMENTAL

Intravenous antibiotics until clinical improvement and then 5 further days of oral antibiotics. Co-amoxiclav, or if rash-allergy to penicillin, cefuroxime and metronidazole.

Drug: Antibiotic treatment

Interventions

Laparoscopic +/- Open Appendicectomy PROCEDURE

Laparoscopic +/- open appendicectomy , with antibiotics at induction (intravenous co-amoxiclav 1.2g, or if penicillin allergic, cefuroxime 1.5g + metronidazole 500mg ), followed by 3 further intravenous doses of the same antibiotic. If a perforation is identified at the time of surgery, microbiology will be contacted regarding choice and duration of of antibiotic.

Operative Intervention

Antibiotic treatment DRUG

Intravenous co-amoxiclav 1.2g three times daily, then 625mg, orally three times daily. If penicillin allergic, intravenous cefuroxime 1.5g three times daily + metronidazole 500mg three times daily, then oral cefuroxime 500mg twice daily + oral metronidazole 400mg three times daily. The patient will receive inpatient intravenous antibiotics until sufficient clinical improvement is noted by the surgical team, who will be assessing the patient twice daily. After discharge the patient will receive 5 further days of oral antibiotics.

Antibiotic Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right iliac fossa pain
• st episode in the past 1 year
• Raised WCC or CRP
• Fluent in English

You may not qualify if:

• History of inflammatory bowel disease or appendectomy
• B-HCG positive
• Significant co-morbidities
• Complicated appendicitis as proven by ultrasound, CT or MRI
• Anaphylaxis to penicillin

Sponsors & Collaborators

• Beaumont Hospital: lead

Study Sites (1)

Beaumont Hospital

Dublin, D9, Ireland

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Arnold K Hill

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 27, 2016
• Study Start: September 12, 2016
• Primary Completion: December 8, 2019
• Study Completion: December 8, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)