Appendicitis Clinical Trial
— ASIOfficial title:
Randomized Clinical Trial to Test the Efficacy and Safety of Outpatient Clinical Management of Urgent Laparoscopic Appendectomy in Uncomplicated Acute Appendicitis
NCT number | NCT05401188 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | January 1, 2022 |
Verified date | May 2022 |
Source | HJ23 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the safety and efficacy of outpatient management of uncomplicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.
Status | Completed |
Enrollment | 120 |
Est. completion date | January 1, 2022 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients over 18 years old - meet at least 4 over 5 Saint Antoine criteria - ASA classification (American Society of Anesthesiologists) less than or equal to 3 - patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital and an adequate cognitive capacity. Exclusion Criteria: - pregnancy or breastfeeding - complicated Acute Appendicitis - surgical management performed in more 90 minutes. |
Country | Name | City | State |
---|---|---|---|
Spain | Jordi Elvira Lopez | Tarragona |
Lead Sponsor | Collaborator |
---|---|
HJ23 | Hospital Universitari Joan XXIII de Tarragona. |
Spain,
Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. — View Citation
Aubry A, Saget A, Manceau G, Faron M, Wagner M, Tresallet C, Riou B, Lucidarme O, le Saché F, Karoui M. Outpatient Appendectomy in an Emergency Outpatient Surgery Unit 24 h a Day: An Intention-to-Treat Analysis of 194 Patients. World J Surg. 2017 Oct;41(1 — View Citation
Cash CL, Frazee RC, Abernathy SW, Childs EW, Davis ML, Hendricks JC, Smith RW. A prospective treatment protocol for outpatient laparoscopic appendectomy for acute appendicitis. J Am Coll Surg. 2012 Jul;215(1):101-5; discussion 105-6. doi: 10.1016/j.jamcol — View Citation
Cash CL, Frazee RC, Smith RW, Davis ML, Hendricks JC, Childs EW, Abernathy SW. Outpatient laparoscopic appendectomy for acute appendicitis. Am Surg. 2012 Feb;78(2):213-5. — View Citation
Di Saverio S, Podda M, De Simone B, Ceresoli M, Augustin G, Gori A, Boermeester M, Sartelli M, Coccolini F, Tarasconi A, De' Angelis N, Weber DG, Tolonen M, Birindelli A, Biffl W, Moore EE, Kelly M, Soreide K, Kashuk J, Ten Broek R, Gomes CA, Sugrue M, Da — View Citation
Frazee RC, Roberts JW, Symmonds RE, Snyder SK, Hendricks JC, Smith RW, Custer MD 3rd, Harrison JB. A prospective randomized trial comparing open versus laparoscopic appendectomy. Ann Surg. 1994 Jun;219(6):725-8; discussion 728-31. — View Citation
Lefrancois M, Lefevre JH, Chafai N, Pitel S, Kerger L, Agostini J, Canard G, Tiret E. Management of Acute Appendicitis in Ambulatory Surgery: Is It Possible? How to Select Patients? Ann Surg. 2015 Jun;261(6):1167-72. doi: 10.1097/SLA.0000000000000795. — View Citation
Paudel GR, Agrawal CS, Regmi R, Agrawal S. Conservative treatment in acute appendicitis. JNMA J Nepal Med Assoc. 2010 Oct-Dec;50(180):295-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | length of hospital stay (LHS) | The length of hospital stay (LHS) was calculated from the date and time of urgent appendectomy surgery to the date and time of hospital discharge, based on the hours of hospital stay (assessed up to 5 days) | up to 5 days | |
Secondary | failures of the outpatient management | Once the patients were discharged home, they were evaluated for emergency room visit. From the date of hospital discharge to the day of emergency room visit. The presence of a emergency room visit is considered as a Failure of the outpatient management. | assessed up to 30 days | |
Secondary | readmissions | Once the patients were discharged home, they were evaluated for readmission to the hospital ward. From the date of hospital discharge to the day of readmission to the hospital ward. The re-admission to the hospitalization ward was considered a readmission. | assessed up to 30 days | |
Secondary | hospitals cost | The economic costs of both clinical managements were evaluated until the end of the study, a mean of 1 year. For the study, the direct and indirect costs of laparoscopic surgery, consumable material, economic expenses in the hospital ward, and the cost of the price of the emergency room visit were evaluated. The hospital's economic department was contacted and they calculated the cost in euros per patient. Each group was evaluated separately and a comparison was made. | through study completion, an average of 1 year |
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