Clinical trial NCT05401188: Clinical Trial for a Outpatient Clinical Management of Urgent Laparoscopic Appendectomy
Official title: Randomized Clinical Trial to Test the Efficacy and Safety of Outpatient Clinical Management of Urgent Laparoscopic Appendectomy in Uncomplicated Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis Acute
Appendicitis
Keywords: outpatient management
Laparoscopic appendicectomy
Lead sponsor: HJ23
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitari Joan XXIII de Tarragona.
First posted: 2022-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in uncomplicated acute appendicitis.

This was a single center randomized controlled clinical trial consisting in 2 treatment groups. Patients were recruited in University Hospital of Tarragona Joan XXIII of Spain.

All patients admitted in the emergency department at University Hospital of Tarragona Joan XXIII with acute appendicitis diagnosis were likely to enter in the study. All patients who accomplished at least 4 over 5 of the Saint-Antoine criteria were included. The 5 criteria were: Leukocytosis lower than 15.000; C-Reactive protein lower than 30mg; Body mass index lower than 30kg/m2; appendicular diameter lower than 10mm and no radiological sign of complication.

All patients who met the inclusion criteria and none of the exclusion criteria were admitted to the study for emergency surgery.

In order to avoid the biases a unique anesthetic and surgical protocol were established for both groups.

Once Laparoscopic appendicectomy was performed the patients were randomly assigned to the hospitalization group or outpatient group.

Patients in the hospitalization group were admitted in the hospitalization ward. Patients in the outpatient group were referred to the day-surgery unit where they were discharged according to ALDRETE criteria.

The primary endpoint was the length of hospital stay (LHS). The length of hospital stay was calculated from the day and hour of admission in the surgical area to the day and hour of discharge, based on the hours of hospital stay. Secondary endpoints included the failures of the outpatient management, readmissions and the hospitals cost.

Eligibility criteria: 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.

Primary outcomes:
measure: length of hospital stay (LHS)
timeFrame: up to 5 days
Secondary outcomes:
measure: failures of the outpatient management
timeFrame: assessed up to 30 days
measure: readmissions
timeFrame: assessed up to 30 days
measure: hospitals cost
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Jordi Elvira Lopez
Study officials:
affiliation: HJ23
name: Jordi Elvira Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.jamcollsurg.2012.02.024. Epub 2012 May 19.
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, Davies RJ, Damaskos D, Leppaniemi A, Kirkpatrick A, Peitzman AB, Fraga GP, Maier RV, Coimbra R, Chiarugi M, Sganga G, Pisanu A, De' Angelis GL, Tan E, Van Goor H, Pata F, Di Carlo I, Chiara O, Litvin A, Campanile FC, Sakakushev B, Tomadze G, Demetrashvili Z, Latifi R, Abu-Zidan F, Romeo O, Segovia-Lohse H, Baiocchi G, Costa D, Rizoli S, Balogh ZJ, Bendinelli C, Scalea T, Ivatury R, Velmahos G, Andersson R, Kluger Y, Ansaloni L, Catena F. Diagnosis and treatment of acute appendicitis: 2020 update of the WSES Jerusalem guidelines. World J Emerg Surg. 2020 Apr 15;15(1):27. doi: 10.1186/s13017-020-00306-3.