NCT04464382

Brief Summary

This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

January 13, 2021

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

February 11, 2020

Last Update Submit

January 12, 2021

Conditions

Appendicitis AcuteAppendectomy

Outcome Measures

Primary Outcomes (2)

  • Rates of ambulatory appendectomy patients that have ambulatory surgery

    Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery

    20 months

  • Rates of readmission of appendectomy patients that had ambulatory surgery

    Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery

    20 months

Secondary Outcomes (4)

  • Prevalence of ambulatory appendectomy patients

    20 months

  • Media of time until the total incorporation to the activities of the daily life after appendectomy

    20 months

  • Rates of satisfaction

    20 months

  • Costs of the outpatient regimen versus the hospitalization of patients

    20 months

Study Arms (2)

Outpatient appendectomy

EXPERIMENTAL

Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.

Procedure: Outpatient (OA)

Hospitalization appendectomy

ACTIVE COMPARATOR

Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.

Procedure: Hospitalization appendectomy (HA)

Interventions

Outpatient (OA)PROCEDURE

Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission.

Outpatient appendectomy
Hospitalization appendectomy (HA)PROCEDURE

Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds.

Hospitalization appendectomy

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 14 years of age and who provide informed consent to participate in the study.
  • Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision)
  • Negative appendicectomy.

You may not qualify if:

  • Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis)
  • Need to place intraoperative drainage.
  • Patients with American Society of Anesthesiologists (ASA) \>IV.
  • Immunosuppressed patients.
  • Pregnant.
  • Possibility of inflammatory bowel disease.
  • No family support.
  • No informed consent signature.
  • Impossibility to comply with the established follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Related Publications (6)

  • Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.

    PMID: 27437029BACKGROUND

  • 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: 22609030BACKGROUND

  • Aguayo P, Alemayehu H, Desai AA, Fraser JD, St Peter SD. Initial experience with same day discharge after laparoscopic appendectomy for nonperforated appendicitis. J Surg Res. 2014 Jul;190(1):93-7. doi: 10.1016/j.jss.2014.03.012. Epub 2014 Mar 12.

    PMID: 24725679BACKGROUND

  • Frazee RC, Abernathy SW, Isbell CL, Isbell T, Regner JL, Smith RD. Outpatient Laparoscopic Appendectomy: Is It Time to End the Discussion? J Am Coll Surg. 2016 Apr;222(4):473-7. doi: 10.1016/j.jamcollsurg.2015.12.053. Epub 2016 Jan 14.

    PMID: 26920990BACKGROUND

  • Frazee R, Burlew CC, Regner J, McIntyre R, Peltz E, Cribari C, Dunn J, Butler L, Reckard P, Dissanaike S, Karimi K, Behnfield C, Melo N, Margulies D. Discussion of: "Outpatient laparoscopic appendectomy can be successfully performed for uncomplicated appendicitis: A Southwestern Surgical Congress multicenter trial". Am J Surg. 2017 Dec;214(6):1010-1011. doi: 10.1016/j.amjsurg.2017.10.003. Epub 2017 Oct 5. No abstract available.

    PMID: 29079020BACKGROUND

  • 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.

    PMID: 31273450BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Pareja C Felipe, PhD

    Hospital Universitario Virgen del Rocio

    PRINCIPAL INVESTIGATOR

  • Padillo R Javier, PhD

    Hospital Universitario Virgen del Rocio

    STUDY DIRECTOR

  • Durán MC Virginia María, MD

    Hospital Universitario Virgen del Rocio

    STUDY CHAIR

Central Study Contacts

Pareja C Felipe, PhD

CONTACT

+34630962443felipe.pareja67@gmail.com

Durán MC Virginia María, MD

CONTACT

+34630962443virginia.dm.87@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

July 9, 2020

Study Start

April 28, 2019

Primary Completion

April 28, 2021

Study Completion

October 28, 2021

Last Updated

January 13, 2021

Record last verified: 2020-07

Locations

ES(1)