Clinical trial NCT04464382: Evaluating the Safety and Efficacy of a Outpatient Appendectomy
Official title: A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendicitis Acute
Appendectomy
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 291
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide.

Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions.

At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization.

There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA.

There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rates of ambulatory appendectomy patients that have ambulatory surgery
timeFrame: 20 months
measure: Rates of readmission of appendectomy patients that had ambulatory surgery
timeFrame: 20 months
Secondary outcomes:
measure: Prevalence of ambulatory appendectomy patients
timeFrame: 20 months
measure: Media of time until the total incorporation to the activities of the daily life after appendectomy
timeFrame: 20 months
measure: Rates of satisfaction
timeFrame: 20 months
measure: Costs of the outpatient regimen versus the hospitalization of patients
timeFrame: 20 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Hospital Universitario Virgen del Rocio
name: Pareja C Felipe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen del Rocio
name: Padillo R Javier, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Virgen del Rocio
name: Durán MC Virginia María, MD
role: STUDY_CHAIR
References:
citation: 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.
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: 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.
citation: 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.
citation: 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.
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.