Acute Appendicitis Clinical Trial
— MODRISOfficial title:
Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis Across Different Ethnic Populations (MODRIS): An International Multicentre Study
NCT number | NCT04207645 |
Other study ID # | 201903311 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | June 30, 2020 |
Verified date | March 2021 |
Source | Soba University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 240 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
India | Azeezia institute of medical sciences and research | Kollam | |
India | Baby memorial hospital | Kozhikode | |
India | Government Medical college and hospital | Kozhikode | |
India | Jubilee Mission Medical College and Research Institute | Thrissur | |
India | Believers church Medical college hospital | Tiruvalla | |
Mexico | Hospital General de Amecameca Valentin Gomez Farías | Amecameca | |
Mexico | Civil Hospital Culiacan | Culiacan | |
Mexico | General Hospital of Culiacan | Culiacan | |
Mexico | Hospital General de Culiacan "Dr. Bernardo J. Gastelum" | Culiacan | |
Mexico | ISSSTE Regional Hospital of Culiacan | Culiacan | |
Mexico | Hospital Civil de Guadalajara | Guadalajara | |
Mexico | Hospital General del estado de Sonora "Dr. Ernesto Ramos Bours" | Hermosillo | |
Mexico | Hospital General de Mexico | Mexico City | |
Mexico | Hospital General Dr. Manuel Gea Gonzalez | Mexico City | |
Mexico | Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | |
Nigeria | Ekiti State University Teaching Hospital | Ado-Ekiti | |
Nigeria | Federal Medical Centre | Birnin-Kebbi | |
Nigeria | Aminu Kano Teaching Hospital | Kano | |
Nigeria | Department of Surgery, Lagos University Teaching Hospital | Lagos | |
Nigeria | Fedral Medical Centre | Owerri | |
Nigeria | Department of Surgery, Port Harcourt University Hospital | Port Harcourt | |
Nigeria | Rivers State University Teaching Hospital | Port Harcourt | |
Pakistan | Department of Surgery, Pakistan Air Force Hospital | Lahore | |
Pakistan | Fatima Memorial Hospital | Lahore | |
Pakistan | Combined Military Hospital | Multan | |
Pakistan | Combined Military Hospital | Rawalpindi | |
Pakistan | Fauji Foundation Hospital | Rawalpindi | |
Spain | Santos Reyes Hospital | Aranda de Duero | |
Spain | Hospital General Mateu Orfila | Menorca | |
Spain | Digestive Surgery Department, Hospital Universitario Son Espases | Palma de Mallorca | |
Spain | Hospital Universitario Nuestra Señora de Valme | Sevilla | |
Spain | Hospital universitario Virgen Macarena | Sevilla | |
Spain | Department of General Surgery, Medina del Campo Hospital | Valladolid | |
Spain | Río Hortega University Hospital | Valladolid | |
Spain | University Clinical Hospital of Valladolid | Valladolid | |
Sudan | Al Mawada Hospital | Khartoum | |
Sudan | Ibrahim Malik Teaching Hospital | Khartoum |
Lead Sponsor | Collaborator |
---|---|
Soba University Hospital |
India, Mexico, Nigeria, Pakistan, Spain, Sudan,
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. Erratum in: Saudi Med J. 2005 Apr;26(4):693. — View Citation
Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Erdem H, Çetinkünar S, Das K, Reyhan E, Deger C, Aziret M, Bozkurt H, Uzun S, Sözen S, Irkörücü 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. — View Citation
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. Review. — View Citation
Grönroos JM, Grönroos P. Leucocyte count and C-reactive protein in the diagnosis of acute appendicitis. Br J Surg. 1999 Apr;86(4):501-4. — View Citation
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. — View Citation
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.
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Palazón-Bru A, Folgado-de la Rosa DM, Cortés-Castell E, López-Cascales MT, Gil-Guillén 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Tanrikulu CS, Karamercan MA, Tanrikulu Y, Öztürk M, Yüzbasioglu 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. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance of each clinical prediction rule (modified RIPASA, RIPASA, and Alvarado score) | Performance is discrimination between appendicitis and no appendicitis | 1 month | |
Secondary | sensitivity of each clinical prediction rule | the ability to diagnose acute appendicitis | 1 month | |
Secondary | specificity of each clinical prediction rule | the ability to diagnose non-appendicitis | 1 month | |
Secondary | Failure rate for each clinical prediction rule | defined as the proportion of patients stratified to the "low-risk" group who do have appendicitis (reciprocal of the negative predictive value) | 1 month | |
Secondary | Postoperative outcomes, including negative appendicectomy rate, in patients who are classified as "low-risk" by each clinical prediction rule | Postoperative outcomes include complications, reintervention, readmission and negative appendicectomy rates | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01697059 -
Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis
|
N/A | |
Completed |
NCT04387370 -
The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?
|
||
Completed |
NCT04649996 -
Variation in Acute Appendicitis During COVID-19 Pandemic in Italy
|
||
Completed |
NCT04030741 -
Non-operative Treatment of Acute Non-perforated Appendicitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04860570 -
Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?
|
||
Withdrawn |
NCT05724628 -
Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations
|
Phase 1 | |
Completed |
NCT01024439 -
Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy
|
N/A | |
Completed |
NCT02714023 -
Water And Saline Head-to-head In The Blinded Evaluation Study Trial
|
N/A | |
Active, not recruiting |
NCT03324165 -
Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis
|
N/A | |
Active, not recruiting |
NCT01022567 -
Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
|
N/A | |
Not yet recruiting |
NCT06059365 -
Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis
|
N/A | |
Not yet recruiting |
NCT06051825 -
Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis
|
||
Recruiting |
NCT04947748 -
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous
|
N/A | |
Completed |
NCT04615728 -
MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
|
||
Not yet recruiting |
NCT02789865 -
Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
|
Phase 2 | |
Completed |
NCT02731924 -
Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
|
||
Completed |
NCT05104346 -
Presentation and Outcomes of Acute Appendicitis During COVID Pandemic
|
N/A | |
Completed |
NCT03886896 -
Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
|
Phase 4 | |
Not yet recruiting |
NCT01720082 -
Laparoscopic Appendectomy by Multi-port vs Single Port.
|
Phase 3 | |
Completed |
NCT01348464 -
A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy
|
N/A |