Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis

NCT04207645 | Terminated

• 1 other identifier: 201903311
• Study Type: observational
• Target: 240
• Locations: 6 countries
• Sites: 37

Brief Summary

Purpose: The diagnostic approach of patients with acute appendicitis (AA) remains debated. A number of clinical prediction rules (CPRs) exist for diagnosis of AA with variable sensitivity, specificity, and diagnostic accuracy, in different ethnic populations. Among these, the Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA) score was shown to have a high sensitivity though with a poor specificity. The aim of this study is to modify and validate the RIPASA score in 4 distinct ethnic groups, and to compare the performance of the new score to the original RIPASA and Alvarado scores. Methods: This multicenter, international prospective observational study will be conducted in 6 countries, and will include all eligible patients referred to surgical specialists with acute right iliac fossa pain or suspected AA in the participating centres. Patients will be categorized into 4 ethnic groups based on the country of origin. The modified RIPASA score will be developed in one ethnic group, and along with the original RIPASA and Alvarado scores, will be externally validated in the other 3 ethnic groups. Management of patients will be prospectively evaluated in a standardized manner. The focus of the analysis will be on the performance of the 3 CPRs in different ethnic and gender groups using receiver operating characteristic curve analyses. Discussion: We expect this study to develop a CPR that can assist surgeons and surgical residents to early identify patients with AA in the busy clinical and low-resource settings, and to optimize the diagnostic value of the RIPASA and Alvarado scores in different ethnic and gender groups.

Conditions

Acute Appendicitis

Keywords

Appendicitis; modified RIPASA score; Clinical prediction rule; Validation; Ethnic group

Outcome Measures

Primary Outcomes (1)

• Performance of each clinical prediction rule (modified RIPASA, RIPASA, and Alvarado score)

  Performance is discrimination between appendicitis and no appendicitis

  1 month

Secondary Outcomes (4)

• sensitivity of each clinical prediction rule

  1 month

• specificity of each clinical prediction rule

  1 month

• Failure rate for each clinical prediction rule

  1 month

• Postoperative outcomes, including negative appendicectomy rate, in patients who are classified as "low-risk" by each clinical prediction rule

  1 month

Study Arms (4)

African

patients originating from Nigeria and Sudan (11 centres)

Diagnostic Test: Modified RIPASA score

Latin American

patients originating from Mexico (5 centres)

Diagnostic Test: Modified RIPASA score

South Asian

patients originating from India and Pakistan (10 centres)

Diagnostic Test: Modified RIPASA score

European

patients originating from Spain (11 centres).

Diagnostic Test: Modified RIPASA score

Interventions

Modified RIPASA score DIAGNOSTIC_TEST

Clinical Prediction Rules consist of clinical and laboratory parameters to aid diagnosis of acute appendicitis

Also known as: RIPASA score and Alvarado score

African; European; Latin American; South Asian

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients age ≥ 16 years with acute right iliac fossa (RIF) pain or suspected acute appendicitis who are attending the acute services of the participating surgical departments during the study period and who has none of the exclusion criteria will be included.

You may qualify if:

• all consecutive patients age ≥ 16 years, who are referred to the on-call surgeon's team with acute right iliac fossa (RIF) pain or suspected acute appendicitis, will be included.

You may not qualify if:

• history of previous appendicectomy
• previous abdominal surgery in the last 90 days
• history of chronic abdominal pathology (e.g. ovarian cyst, colitis .. etc)
• history of inguinal hernia
• pregnancy

Sponsors & Collaborators

• Soba University Hospital: lead

Study Sites (37)

Azeezia institute of medical sciences and research

Kollam, India

Location

Baby memorial hospital

Kozhikode, India

Location

Government Medical college and hospital

Kozhikode, India

Location

Jubilee Mission Medical College and Research Institute

Thrissur, India

Location

Believers church Medical college hospital

Tiruvalla, India

Location

Hospital General de Amecameca Valentin Gomez Farías

Amecameca de Juárez, Mexico

Location

Civil Hospital Culiacan

Culiacán, Mexico

Location

General Hospital of Culiacan

Culiacán, Mexico

Location

Hospital General de Culiacan "Dr. Bernardo J. Gastelum"

Culiacán, Mexico

Location

ISSSTE Regional Hospital of Culiacan

Culiacán, Mexico

Location

Hospital Civil de Guadalajara

Guadalajara, Mexico

Location

Hospital General del estado de Sonora "Dr. Ernesto Ramos Bours"

Hermosillo, Mexico

Location

Hospital General de Mexico

Mexico City, Mexico

Location

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

Location

Ekiti State University Teaching Hospital

Ado-Ekiti, Nigeria

Location

Federal Medical Centre

Birnin Kebbi, Nigeria

Location

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

Department of Surgery, Lagos University Teaching Hospital

Lagos, Nigeria

Location

Fedral Medical Centre

Owerri, Nigeria

Location

Department of Surgery, Port Harcourt University Hospital

Port Harcourt, Nigeria

Location

Rivers State University Teaching Hospital

Port Harcourt, Nigeria

Location

Department of Surgery, Pakistan Air Force Hospital

Lahore, Pakistan

Location

Fatima Memorial Hospital

Lahore, Pakistan

Location

Combined Military Hospital

Multan Khurd, Pakistan

Location

Combined Military Hospital

Rawalpindi, Pakistan

Location

Fauji Foundation Hospital

Rawalpindi, Pakistan

Location

Santos Reyes Hospital

Aranda de Duero, Spain

Location

Hospital General Mateu Orfila

Menorca, Spain

Location

Digestive Surgery Department, Hospital Universitario Son Espases

Palma de Mallorca, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, Spain

Location

Hospital universitario Virgen Macarena

Seville, Spain

Location

Department of General Surgery, Medina del Campo Hospital

Valladolid, Spain

Location

Río Hortega University Hospital

Valladolid, Spain

Location

University Clinical Hospital of Valladolid

Valladolid, Spain

Location

Al Mawada Hospital

Khartoum, Sudan

Location

Ibrahim Malik Teaching Hospital

Khartoum, Sudan

Location

Related Publications (22)

• Kularatna M, Lauti M, Haran C, MacFater W, Sheikh L, Huang Y, McCall J, MacCormick AD. Clinical Prediction Rules for Appendicitis in Adults: Which Is Best? World J Surg. 2017 Jul;41(7):1769-1781. doi: 10.1007/s00268-017-3926-6.

  PMID: 28258458 BACKGROUND

• Kalan M, Talbot D, Cunliffe WJ, Rich AJ. Evaluation of the modified Alvarado score in the diagnosis of acute appendicitis: a prospective study. Ann R Coll Surg Engl. 1994 Nov;76(6):418-9.

  PMID: 7702329 BACKGROUND

• Ohle R, O'Reilly F, O'Brien KK, Fahey T, Dimitrov BD. The Alvarado score for predicting acute appendicitis: a systematic review. BMC Med. 2011 Dec 28;9:139. doi: 10.1186/1741-7015-9-139.

  PMID: 22204638 BACKGROUND

• Al-Hashemy AM, Seleem MI. Appraisal of the modified Alvarado Score for acute appendicits in adults. Saudi Med J. 2004 Sep;25(9):1229-31.

  PMID: 15448772 BACKGROUND

• Khan I, ur Rehman A. Application of alvarado scoring system in diagnosis of acute appendicitis. J Ayub Med Coll Abbottabad. 2005 Jul-Sep;17(3):41-4.

  PMID: 16320795 BACKGROUND

• Ozkan S, Duman A, Durukan P, Yildirim A, Ozbakan O. The accuracy rate of Alvarado score, ultrasonography, and computerized tomography scan in the diagnosis of acute appendicitis in our center. Niger J Clin Pract. 2014 Jul-Aug;17(4):413-8. doi: 10.4103/1119-3077.134001.

  PMID: 24909462 BACKGROUND

• Bhattacharjee PK, Chowdhury T, Roy D. Prospective evaluation of modified Alvarado score for diagnosis of acute appendicitis. J Indian Med Assoc. 2002 May;100(5):310-1, 314.

  PMID: 12418631 BACKGROUND

• Tade AO. Evaluation of Alvarado score as an admission criterion in patients with suspected diagnosis of acute appendicitis. West Afr J Med. 2007 Jul-Sep;26(3):210-2. doi: 10.4314/wajm.v26i3.28311.

  PMID: 18399336 BACKGROUND

• Erdem H, Cetinkunar S, Das K, Reyhan E, Deger C, Aziret M, Bozkurt H, Uzun S, Sozen S, Irkorucu O. Alvarado, Eskelinen, Ohhmann and Raja Isteri Pengiran Anak Saleha Appendicitis scores for diagnosis of acute appendicitis. World J Gastroenterol. 2013 Dec 21;19(47):9057-62. doi: 10.3748/wjg.v19.i47.9057.

  PMID: 24379631 BACKGROUND

• Frountzas M, Stergios K, Kopsini D, Schizas D, Kontzoglou K, Toutouzas K. Alvarado or RIPASA score for diagnosis of acute appendicitis? A meta-analysis of randomized trials. Int J Surg. 2018 Aug;56:307-314. doi: 10.1016/j.ijsu.2018.07.003. Epub 2018 Jul 12.

  PMID: 30017607 BACKGROUND

• Tanrikulu CS, Karamercan MA, Tanrikulu Y, Ozturk M, Yuzbasioglu Y, Coskun F. The predictive value of Alvarado score, inflammatory parameters and ultrasound imaging in the diagnosis of acute appendicitis. Ulus Cerrahi Derg. 2015 Jun 1;32(2):115-21. doi: 10.5152/UCD.2015.3103. eCollection 2016.

  PMID: 27436936 BACKGROUND

• Dueholm S, Bagi P, Bud M. Laboratory aid in the diagnosis of acute appendicitis. A blinded, prospective trial concerning diagnostic value of leukocyte count, neutrophil differential count, and C-reactive protein. Dis Colon Rectum. 1989 Oct;32(10):855-9. doi: 10.1007/BF02554555.

  PMID: 2676422 BACKGROUND

• Chong CF, Adi MI, Thien A, Suyoi A, Mackie AJ, Tin AS, Tripathi S, Jaman NH, Tan KK, Kok KY, Mathew VV, Paw O, Chua HB, Yapp SK. Development of the RIPASA score: a new appendicitis scoring system for the diagnosis of acute appendicitis. Singapore Med J. 2010 Mar;51(3):220-5.

  PMID: 20428744 BACKGROUND

• Khalil OA (2013) Using of the modified RIPAS score in diagnosis of acute appendicitis to decrease use of abdominal computed tomography. Egyptian J Surg 32:86-90.

  BACKGROUND

• Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.

  PMID: 3963537 BACKGROUND

• Shelton JA, Brown JJ, Young JA. Preoperative C-reactive protein predicts the severity and likelihood of complications following appendicectomy. Ann R Coll Surg Engl. 2014 Jul;96(5):369-72. doi: 10.1308/003588414X13946184901722.

  PMID: 24992421 BACKGROUND

• Gronroos JM, Gronroos P. Leucocyte count and C-reactive protein in the diagnosis of acute appendicitis. Br J Surg. 1999 Apr;86(4):501-4. doi: 10.1046/j.1365-2168.1999.01063.x.

  PMID: 10215824 BACKGROUND

• Msolli MA, Beltaief K, Bouida W, Jerbi N, Grissa MH, Boubaker H, Boukef R, Nouira S. Value of early change of serum C reactive protein combined to modified Alvarado score in the diagnosis of acute appendicitis. BMC Emerg Med. 2018 May 24;18(1):15. doi: 10.1186/s12873-018-0166-5.

  PMID: 29793425 BACKGROUND

• Palazon-Bru A, Folgado-de la Rosa DM, Cortes-Castell E, Lopez-Cascales MT, Gil-Guillen VF. Sample size calculation to externally validate scoring systems based on logistic regression models. PLoS One. 2017 May 1;12(5):e0176726. doi: 10.1371/journal.pone.0176726. eCollection 2017.

  PMID: 28459847 BACKGROUND

• Kong VY, Bulajic B, Allorto NL, Handley J, Clarke DL. Acute appendicitis in a developing country. World J Surg. 2012 Sep;36(9):2068-73. doi: 10.1007/s00268-012-1626-9.

  PMID: 22562453 BACKGROUND

• Kong VY, van der Linde S, Aldous C, Handley JJ, Clarke DL. The accuracy of the Alvarado score in predicting acute appendicitis in the black South African population needs to be validated. Can J Surg. 2014 Aug;57(4):E121-5. doi: 10.1503/cjs.023013.

  PMID: 25078937 BACKGROUND

• Scarborough JE, Bennett KM, Pappas TN. Racial disparities in outcomes after appendectomy for acute appendicitis. Am J Surg. 2012 Jul;204(1):11-7. doi: 10.1016/j.amjsurg.2011.05.020. Epub 2011 Dec 7.

  PMID: 22154135 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hytham KS Hamid, MRCSEd

  Soba University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: November 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

PA (5); ES (8); SU (2); ME (10); IN (5); NG (7)