Evaluating the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

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

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

Study Overview

• Status: Unknown
• Conditions: Appendicitis Acute; Appendectomy
• Intervention / Treatment: Procedure: Outpatient (OA); Procedure: Hospitalization appendectomy (HA)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 291
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pareja C Felipe, PhD; Phone Number: +34630962443; Email: felipe.pareja67@gmail.com
• Study Contact Backup: Name: Durán MC Virginia María, MD; Phone Number: +34630962443; Email: virginia.dm.87@gmail.com

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Contact: Pareja C Felipe, PhD; Phone Number: +34630962443; Email: felipe.pareja67@gmail.com
    • Contact: Durán MC Virginia, MD; Phone Number: +34620073024; Email: virginia.dm.87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient appendectomy; 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); 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.
Active Comparator: Hospitalization appendectomy; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rates of satisfaction	Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.	20 months
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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: Pareja C Felipe, PhD, Hospital Universitario Virgen del Rocio; Study Director: Padillo R Javier, PhD, Hospital Universitario Virgen del Rocio; Study Chair: Durán MC Virginia María, MD, Hospital Universitario Virgen del Rocio

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2019
• Primary Completion (Anticipated): April 28, 2021
• Study Completion (Anticipated): October 28, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: PENDI_CSI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No