Clinical Trial for a Outpatient Clinical Management of Urgent Laparoscopic Appendectomy

NCT05401188 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute; Appendicitis

Keywords

outpatient management; Laparoscopic appendicectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• failures of the outpatient management

  assessed up to 30 days

• readmissions

  assessed up to 30 days

• hospitals cost

  through study completion, an average of 1 year

Study Arms (2)

hospitalization group

ACTIVE COMPARATOR

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.

Other: hospitalization

outpatient group

EXPERIMENTAL

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.

Other: Outpatient

Interventions

Outpatient OTHER

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.

outpatient group

hospitalization OTHER

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.

hospitalization group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: patients over 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy or breastfeeding
• complicated Acute Appendicitis
• surgical management performed in more 90 minutes.

Sponsors & Collaborators

• HJ23: lead
• Hospital Universitari Joan XXIII de Tarragona.: collaborator

Study Sites (1)

Jordi Elvira Lopez

Tarragona, 43005, Spain

Location

Related Publications (9)

• 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.

  PMID: 24950287 RESULT

• 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.

  PMID: 22049894 RESULT

• 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 RESULT

• 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.

  PMID: 8203983 RESULT

• 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.

  PMID: 22369831 RESULT

• 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.

  PMID: 28474273 RESULT

• 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.

  PMID: 22609030 RESULT

• 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.

  PMID: 32295644 RESULT

• 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.

  PMID: 36419071 DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jordi Elvira Lopez, MD

  HJ23

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)