Evaluating the Safety and Efficacy of a Outpatient Appendectomy

Appendicitis Acute Clinical Trial

— PENDI_CSI  

Official title:

A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464382
• Other study ID #: PENDI_CSI
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2019
• Est. completion date: October 28, 2021

Study information

• Verified date: July 2020
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Pareja C Felipe, PhD
• Phone: +34630962443
• Email: felipe.pareja67[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 291
• Est. completion date: October 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendectomy
• Appendicitis
• Appendicitis Acute

Intervention

Procedure:
• Outpatient (OA)
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.
• Hospitalization appendectomy (HA)
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Del Rocio	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Trejo-Avila M, Cárdenas-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of ambulatory appendectomy patients that have ambulatory surgery	Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery	20 months
Primary	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	Prevalence of ambulatory appendectomy patients	Measure the percentage of ambulatory surgery and uncomplicated acute appendicitis vs the percentage of ambulatory surgery in failure patients with the same pathology e.g.; Uncontrolled abdominal pain with analgesia.; Upper airway discomfort related to intubation that is not controlled with medication.; Pain in the back or shoulders in relation to the pneumoperitoneum that are in patients with not controlled with the medication.; Hemodynamically abnormal. Uncontrolled bleeding at the level of any of the wounds. Need for reoperation. Need to re-enter or consult the Emergency Service No spontaneous urination.; Nausea / vomiting.; Oral intolerance.; No wandering.; Insecurity or fear of the patient at discharge.	20 months
Secondary	Media of time until the total incorporation to the activities of the daily life after appendectomy	To value the time until the total incorporation to the activities of the daily life after appendectomy.	20 months
Secondary	Rates of satisfaction	Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.	20 months
Secondary	Costs of the outpatient regimen versus the hospitalization of patients	Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis).	20 months