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Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis (ASI2)

Primary Purpose

Acute Appendicitis, Appendicitis Perforated, Appendicitis Suppurative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hospitalization
Outpatient
Sponsored by
HJ23
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients over 18 years old 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    hospitalization group

    outpatient group

    Arm Description

    Patients in the hospitalization group, once the surgical intervention was finished, were transferred to the postoperative recovery unit and later they were discharged to the usual hospital ward. Patients received adequate intravenous fluid resuscitation based on their individual hemodynamic parameter and fluid balance, and they received analgesia according to personal requirement. In the hospital ward, the usual patient management protocols were followed until a complete recovery and consequently discharged according to the usual criteria

    Patients in the outpatient group , once operated, were transferred to the surgery unit without admission and were later discharged home if they met the ALDRETE criteria in less than 23 hours after the intervention (following the surgery criteria without admission stages). If the patient was operated during the night shift, following the advice of major outpatient surgery where overnight stays are allowed, the patient was admitted to the post-anesthetic recovery unit and discharged the next day, always in less than 23 hours. In case of being discharged after 23 hours or not meeting ALDRETE criteria, it was considered a failure of the outpatient treatment.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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.
    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.
    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

    Full Information

    First Posted
    September 23, 2023
    Last Updated
    September 23, 2023
    Sponsor
    HJ23
    Collaborators
    Hospital Universitari Joan XXIII de Tarragona.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06059365
    Brief Title
    Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis
    Acronym
    ASI2
    Official Title
    Randomized Clinical Trial to Test the Efficacy and Safety of Outpatient Clinical Management of Urgent Laparoscopic Appendectomy in Complicated Acute Appendicitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HJ23
    Collaborators
    Hospital Universitari Joan XXIII de Tarragona.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the safety and efficacy of outpatient management of complicated 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 complicated 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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Appendicitis, Appendicitis Perforated, Appendicitis Suppurative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hospitalization group
    Arm Type
    Active Comparator
    Arm Description
    Patients in the hospitalization group, once the surgical intervention was finished, were transferred to the postoperative recovery unit and later they were discharged to the usual hospital ward. Patients received adequate intravenous fluid resuscitation based on their individual hemodynamic parameter and fluid balance, and they received analgesia according to personal requirement. In the hospital ward, the usual patient management protocols were followed until a complete recovery and consequently discharged according to the usual criteria
    Arm Title
    outpatient group
    Arm Type
    Experimental
    Arm Description
    Patients in the outpatient group , once operated, were transferred to the surgery unit without admission and were later discharged home if they met the ALDRETE criteria in less than 23 hours after the intervention (following the surgery criteria without admission stages). If the patient was operated during the night shift, following the advice of major outpatient surgery where overnight stays are allowed, the patient was admitted to the post-anesthetic recovery unit and discharged the next day, always in less than 23 hours. In case of being discharged after 23 hours or not meeting ALDRETE criteria, it was considered a failure of the outpatient treatment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hospitalization
    Intervention Description
    Once the patient was operated and an uncomplicated appendicitis was confirmed, the patient was randomized to one of the two experimental branches: the hospitalization group (HG) or outpatient group (OG). In this group, were admitted in the hospitalization ward
    Intervention Type
    Behavioral
    Intervention Name(s)
    Outpatient
    Intervention Description
    Once the patient was operated and an uncomplicated appendicitis was confirmed, the patient was randomized to one of the two experimental branches: the hospitalization group (HG) or outpatient group (OG). Patients in the OG were referred to the day- surgery unit where they were discharged according to ALDRETE criteria.
    Primary Outcome Measure Information:
    Title
    length of hospital stay (LHS)
    Description
    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)
    Time Frame
    up to 5 days
    Secondary Outcome Measure Information:
    Title
    failures of the outpatient management
    Description
    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.
    Time Frame
    assessed up to 30 days
    Title
    readmissions
    Description
    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.
    Time Frame
    assessed up to 30 days
    Title
    hospitals cost
    Description
    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
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    patients over 18 years old
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients over 18 years old 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jordi Elvira Lopez, MD, PhD
    Phone
    0034686917760
    Email
    jelvira.hj23.ics@gencat.cat
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jordi Elvira Lopez, MD, PhD
    Organizational Affiliation
    HJ23
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24950287
    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.
    Results Reference
    background
    PubMed Identifier
    8203983
    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. doi: 10.1097/00000658-199406000-00017.
    Results Reference
    background
    PubMed Identifier
    22369831
    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.
    Results Reference
    background
    PubMed Identifier
    28474273
    Citation
    Aubry A, Saget A, Manceau G, Faron M, Wagner M, Tresallet C, Riou B, Lucidarme O, le Sache 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(10):2471-2479. doi: 10.1007/s00268-017-4034-3.
    Results Reference
    background
    PubMed Identifier
    32295644
    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.
    Results Reference
    background
    PubMed Identifier
    31273450
    Citation
    Trejo-Avila M, Cardenas-Lailson E, Valenzuela-Salazar C, Herrera-Esquivel J, Moreno-Portillo M. Ambulatory versus conventional laparoscopic appendectomy: a systematic review and meta-analysis. Int J Colorectal Dis. 2019 Aug;34(8):1359-1368. doi: 10.1007/s00384-019-03341-y. Epub 2019 Jul 5.
    Results Reference
    background
    PubMed Identifier
    36419071
    Citation
    Elvira Lopez J, Sales Mallafre R, Padilla Zegarra E, Carrillo Luna L, Ferreres Serafini J, Tully R, Memba Ikuga R, Jorba Martin R. Outpatient management of acute uncomplicated appendicitis after laparoscopic appendectomy: a randomized controlled trial. World J Emerg Surg. 2022 Nov 23;17(1):59. doi: 10.1186/s13017-022-00465-5.
    Results Reference
    background

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    Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis

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