Raja Isteri Pengiran Anak Saleha Appendicitis Treatment Without Operation

NCT03169114 | Terminated DMC

• 1 other identifier: Ripas
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The RIPASA score is a Clinical Prediction Rule (CPR) for the diagnosis of acute appendicitis. Since its inception in 2009, the RIPASA score has been validated in various population in healthcare institutions around the world and reported significantly higher sensitivity and specificity when compared to Alvarado score. RIPASA score ranges from 3 to 16.5 with those having a score of less than 7 having a low probability of acute appendicitis and those with a score of 7.5 having a high probability of acute appendicitis. There has been a trend in the past decade on non-operative management of early-uncomplicated acute appendicitis (EuAA) with antibiotic therapy. This antibiotic non-operative management strategy (AMS) has been reported to work in children, thus avoiding unnecessary emergency operation. In adults presenting with early-uncomplicated acute appendicitis, this management pathway is still uncertain and most randomized controlled trials (RCT) and meta-analysis have not been able to show significant benefit of AMS over surgery management strategy (SMS), partly due to variable treatment efficacy, high recurrence rate within a year and a lack of agreement of whom would constitute a group of EuAA. The working hypothesis of this study is that RIPASA score as a Clinical Prediction Rule, can determine a group of patients with a diagnosis of EuAA, based on the range of scores (RIPASA score 7.5 - 11.5), who will benefit from an AMS rather than SMS, leading to improve patients' outcomes through a significant reduction in negative appendicectomy rate, shorter length of hospital stay, reduce post-operative complications and changing physician behavior in managing this group of patients to an AMS rather than SMS and ultimately financial cost savings. The primary specific aim of this study is to compare AMS with SMS in patients with EuAA in a prospective non-inferiority RCT. Secondary specific aims are to determine the range of RIPASA score that can define a group of patients with EuAA, step 3 validation of RIPASA score as a valid CPR and improve patient outcomes in terms of reducing unnecessary negative appendicectomy rate, hospital stay and complications arising from such surgery, and ultimately financial cost savings.

Conditions

Appendicitis; Surgery

Keywords

Appendicitis; Surgery; Antibiotic therapy; RIPASA Score

Outcome Measures

Primary Outcomes (1)

• Number of cases of treatment failures in each arm

  Treatment failure for AMS is defined as cases where surgery is performed unplanned from time of randomisation up to 30 days follow up with positive histopathological confirmation of acute appendicitis (suppurative or gangrenous or perforated). Treatment failure for SMS group is defined as the unnecessary operation performed where the histopathological report is that of normal appendix, as an indicator of negative appendicectomy rate or cases who did not undergo surgery from time of randomisaton up to 30 days follow-up.

  30 days

Secondary Outcomes (7)

• Length of hospital stay

  72 to 168 hours

• Treatment related complications

  30 days

• Recurrence rate

  1 year

• Treatment cost in US dollar

  1 year

• Defining a group with RIPASA score range where AMS is most beneficial

  30 days

Study Arms (2)

Amikacin injection

ACTIVE COMPARATOR

Antibiotic Non-Operative Management Strategy

Drug: Amikacin Injection

Appendicectomy

ACTIVE COMPARATOR

Surgery Management Strategy

Procedure: Appendicectomy

Interventions

Amikacin Injection DRUG

Participants allocated to Antibiotic Non-operative Management Strategy will be given intravenous Amikacin 15mg/kg/day divided over 3 doses for first 48 hours and followed by oral ciprofloxacin 500mg bd for 7 days

Also known as: Amikin

Amikacin injection

Appendicectomy PROCEDURE

Patients allocated to Surgery Management Strategy will undergo appendicectomy

Also known as: Appendectomy

Appendicectomy

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 12 years of age
• High probability of early-uncomplicated acute appendicitis with confirmed RIPASA score of 7.5 to 11.5

You may not qualify if:

• years of age or less
• RIPASA score 7 or less, or greater than 12
• Clinical diagnosis of acute complicated appendicitis with perforation or signs of generalized peritonitis.

Sponsors & Collaborators

• Raja Isteri Pengiran Anak Saleha Hospital: lead

Study Sites (1)

Raja Isteri Pengiran Anak Saleha Hospital

Bandar Seri Begawan, Daerah Brunei dan Muara, BA1710, Brunei

Location

Related Publications (46)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Amikacin; Appendectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Chee Fui Chong, FRCSEd

  RIPAS Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors - Histopathologists will be masked in terms of allocation of the study participants, when reporting histology specimen of appendix removed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Model Details: Non-Inferiority Randomized Controlled Trial

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)