Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203751640059 Date of Approval: 28/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Antibiotics vs. Appendectomy for the Treatment of CT-Uncomplicated Acute Appendicitis in Adults
Official scientific title Antibiotics vs. Appendectomy for the Treatment of CT-Uncomplicated Acute Appendicitis in Adults
Brief summary describing the background and objectives of the trial Acute appendicitis (AA) is the most common surgical emergency. For a long time, perforation was considered as the ultimate outcome of AA; motivating appendectomy which remains the standard treatment. New data have come to clarify the role of the appendix, providing the rationale for conservative treatment. Non-operative treatment (NOT) has been evaluated through several recent trials and meta-analyses, which support primary antibiotic treatment of uncomplicated AA. Despite its significant recurrence and failure rate, NOT does not seem to increase the risk of appendicular perforation. In addition, NOT, compared to appendectomy, appears to be associated with less morbidity, lower cost of care and quality of life preservation. First-line NOT seems to be a reasonable approach for the management of CT scan-confirmed uncomplicated AA. Strict patient selection would certainly improve the success rate. So far, no western trial has been able to demonstrate the non-inferiority of antibiotics compared to surgery. Through a rigorous selection of patients, the main objective of the Knoma trial, which is clearly the first non-Western clinical trial, is to demonstrate the non-inferiority of antibiotic therapy compared to appendectomy in the treatment of acute uncomplicated appendicitis in adults.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KNOMA
Disease(s) or condition(s) being studied Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Appendectomy not applicable It consists of an appendectomy by laparotomy or laparoscopy. Patients in the surgery group will be discharged after 24 hours. All appendectomy specimens will be examined histopathologically, and appendicitis will be confirmed by neutrophilic infiltration of the muscularis. 90 Active-Treatment of Control Group
Experimental Group Antibiotics 9 days This consists of intravenous antibiotic therapy with Amoxicillin + Clavulanic Acid 3g/24h or Claforan 1g/8h + Metronidazole 500mg/8h (depending on availability). In case of allergy to Betalactam, Ciprofloxacin 200mg/8h will be administered. At the end of the 48 hours of hospitalization, and in front of the improvement of the clinical and biological signs; in other words, apyrexia, attenuation of the pain and the abdominal defense as well as a decreasing cinetic of WBC and CRP, the patient will be discharged with an antibiotic relay per os during 7 days. 90
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients aged 15-65 years - Acute uncomplicated appendicitis with a diameter between 6 - 14mm confirmed by an injected CT scan - AIR score ≥ 5 - Age over 65 years - Complicated acute appendicitis (stercolith, peri-appendicular abcess or intraperitoneal fluid, perforation, pneumoperitoneum) - Appendicular diameter > 14mm (injected CT) - AIR score ≤ 4 - History of inflammatory bowel disease - Treatment with corticosteroids - Pregnancy in progress - Allergy to iodine - Renal insufficiency (creatinine clearance <30 ml/min) - Refusal to participate Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/03/2022 Bachir Mentouri University Hospital Scientific Committee
Ethics Committee Address
Street address City Postal code Country
Road of the hospital of Kouba Algiers 16208 Algeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall failure rate: defined as the number of patients operated on (Antibiotics group) or reoperated on (Appendectomy group) for postoperative complications (peritonitis, intestinal obstruction, incisional hernia) during one-year follow-up. during one-year follow-up.
Secondary Outcome - Recurrences rate: defined as the number of patients with a recurrence of acute appendicitis in the antibiotics group during one year of follow-up. - Pain intensity on day 1: defined as the mean of the VAS values calculated on day 1. - Quantity of analgesic received: mean in grams of analgesic received during hospitalization. - Morbidity rate: number of postoperative complications according to the Clavien-Dindo classification. - Readmission rate: number of re-hospitalizations for recurrence or complications. - Length of hospital stay: number of days in hospital. - Duration of physical disability: number of days the patient is unable to carry out daily activities. during one year of follow-up.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EPH Kouba Kouba Hospital Road, Kouba, 16208, Algiers, Algeria Algiers 16208 Algeria
FUNDING SOURCES
Name of source Street address City Postal code Country
EPH Kouba Kouba Hospital Road, Kouba, 16208, Algiers, Algeria Algiers 16208 Algeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EPH Kouba Kouba Hospital Road, Kouba, 16208, Algiers, Algeria Algiers 16208 Algeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hani Bendib hanibendib@gmail.com +213550742110 520 lgts, Bt42 N5, GDC
City Postal code Country Position/Affiliation
Algiers 16200 Algeria Algiers 1 University
Role Name Email Phone Street address
Public Enquiries Hani Bendib hanibendib@gmail.com +213550742110 520 logt, Bt42 N5, GDC
City Postal code Country Position/Affiliation
Algiers 16200 Algeria Departement of general Surgery
Role Name Email Phone Street address
Scientific Enquiries Hani Bendib hanibendib@gmail.com +213550742110 520 lgts, bt42 N5, GDC
City Postal code Country Position/Affiliation
Algiers 16200 Algeria Departement of general Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information