NCT05511194

Brief Summary

Complicated appendicitis in pediatrics is frequent, potentially serious and complex to manage. The implementation of a ERAS model would allow optimizing perioperative care, offering a shorter hospital stay, reducing complications associated with medical care and costs, although adequate multidisciplinary management is necessary. The objective of the study is to evaluate the safety and efficacy of the application of a ERAS therapeutic protocol and compare them with the safety and efficacy of conventional management in children with complicated appendicitis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 16, 2022

Last Update Submit

August 19, 2022

Conditions

Enhanced Recovery After SurgeryAppendicitisChildren, Only

Keywords

Enhanced Recovery After SurgeryAppendicitis complicatedAppendectomyChildrenPerioperative period

Outcome Measures

Primary Outcomes (2)

  • Hospitalary stay

    Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.

    120 days

  • Complications

    Adverse events presented as a consequence of the evolution of a disease or a medical intervention. Indicator of safety of the intervention carried out.

    120 days

Secondary Outcomes (1)

  • Hospital costs

    120 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).

Other: Enhanced Recovery After Surgery therapeutic protocol

Control Group

OTHER

Control Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).

Other: Conventional management

Interventions

Enhanced Recovery After Surgery therapeutic protocolOTHER

Feeding and early ambulation, double short IV antibiotic regimen.

Experimental Group
Conventional managementOTHER

Delayed feeding and ambulation, triple short IV antibiotic regimen.

Control Group

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients between the ages of 1 and 17, who underwent surgery at the UMAE Hospital de Pediatría CMNO and who at the time of surgery are determined to be in a gangrenous or perforated phase.

You may not qualify if:

  • Patients who, prior to surgery, present symptoms of intestinal obstruction, abdominal sepsis, or suffer from any underlying disease.
  • Patients who require placement of a nasogastric tube or abdominal drainage during the intervention.
  • Patients who were operated in another unit and enter the service for follow-up.
  • Patients whose legal guardians do not agree to sign consent to participate in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (33)

  • Omling E, Salo M, Saluja S, Bergbrant S, Olsson L, Persson A, Bjork J, Hagander L. Nationwide study of appendicitis in children. Br J Surg. 2019 Nov;106(12):1623-1631. doi: 10.1002/bjs.11298. Epub 2019 Aug 6.

    PMID: 31386195RESULT

  • Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.

    PMID: 2239906RESULT

  • Garst GC, Moore EE, Banerjee MN, Leopold DK, Burlew CC, Bensard DD, Biffl WL, Barnett CC, Johnson JL, Sauaia A. Acute appendicitis: a disease severity score for the acute care surgeon. J Trauma Acute Care Surg. 2013 Jan;74(1):32-6. doi: 10.1097/TA.0b013e318278934a.

    PMID: 23271074RESULT

  • Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.

    PMID: 26460662RESULT

  • Bonadio W, Rebillot K, Ukwuoma O, Saracino C, Iskhakov A. Management of Pediatric Perforated Appendicitis: Comparing Outcomes Using Early Appendectomy Versus Solely Medical Management. Pediatr Infect Dis J. 2017 Oct;36(10):937-941. doi: 10.1097/INF.0000000000001025.

    PMID: 26669739RESULT

  • Bolmers MD, van Rossem CC, Gorter RR, Bemelman WA, van Geloven AAW, Heij HA; Snapshot Appendicitis Collaborative Study group. Imaging in pediatric appendicitis is key to a low normal appendix percentage: a national audit on the outcome of appendectomy for appendicitis in children. Pediatr Surg Int. 2018 May;34(5):543-551. doi: 10.1007/s00383-018-4244-2. Epub 2018 Mar 9.

    PMID: 29523946RESULT

  • Fujishiro J, Watanabe E, Hirahara N, Terui K, Tomita H, Ishimaru T, Miyata H. Laparoscopic Versus Open Appendectomy for Acute Appendicitis in Children: a Nationwide Retrospective Study on Postoperative Outcomes. J Gastrointest Surg. 2021 Apr;25(4):1036-1044. doi: 10.1007/s11605-020-04544-3. Epub 2020 Mar 3.

    PMID: 32128682RESULT

  • Knaapen M, van Amstel P, van Amstel T, The SML, Bakx R, van Heurn ELWE, Gorter RR. Outcomes after appendectomy in children with acute appendicitis treated at a tertiary paediatric centre: results from a retrospective cohort study. Langenbecks Arch Surg. 2021 Feb;406(1):163-169. doi: 10.1007/s00423-020-01976-y. Epub 2020 Aug 28.

    PMID: 32860108RESULT

  • Martinez-Perez A, Paya-Llorente C, Santarrufina-Martinez S, Sebastian-Tomas JC, Martinez-Lopez E, de'Angelis N. Predictors for prolonged length of stay after laparoscopic appendectomy for complicated acute appendicitis in adults. Surg Endosc. 2021 Jul;35(7):3628-3635. doi: 10.1007/s00464-020-07841-9. Epub 2020 Aug 7.

    PMID: 32767147RESULT

  • Howell EC, Dubina ED, Lee SL. Perforation risk in pediatric appendicitis: assessment and management. Pediatric Health Med Ther. 2018 Oct 26;9:135-145. doi: 10.2147/PHMT.S155302. eCollection 2018.

    PMID: 30464677RESULT

  • Zavras N, Vaos G. Management of complicated acute appendicitis in children: Still an existing controversy. World J Gastrointest Surg. 2020 Apr 27;12(4):129-137. doi: 10.4240/wjgs.v12.i4.129.

    PMID: 32426092RESULT

  • Zani A, Hall NJ, Rahman A, Morini F, Pini Prato A, Friedmacher F, Koivusalo A, van Heurn E, Pierro A. European Paediatric Surgeons' Association Survey on the Management of Pediatric Appendicitis. Eur J Pediatr Surg. 2019 Feb;29(1):53-61. doi: 10.1055/s-0038-1668139. Epub 2018 Aug 15.

    PMID: 30112745RESULT

  • Yousef Y, Youssef F, Homsy M, Dinh T, Pandya K, Stagg H, Baird R, Laberge JM, Poenaru D, Puligandla P, Shaw K, Emil S. Standardization of care for pediatric perforated appendicitis improves outcomes. J Pediatr Surg. 2017 Dec;52(12):1916-1920. doi: 10.1016/j.jpedsurg.2017.08.054. Epub 2017 Sep 5.

    PMID: 28935397RESULT

  • Lam JY, Beaudry P, Simms BA, Brindle ME. Impact of implementing a fast-track protocol and standardized guideline for the management of pediatric appendicitis. Can J Surg. 2021 Jul 5;64(4):E364-E370. doi: 10.1503/cjs.005420.

    PMID: 34223740RESULT

  • Do-Wyeld M, Cundy TP, Court-Kowalski S, Dandie L, Cooper C, Burgoyne L, Cooksey R, Khurana S. Improving quality and efficiency of care for advanced appendicitis in children. ANZ J Surg. 2021 Jul;91(7-8):1497-1503. doi: 10.1111/ans.16929. Epub 2021 May 20.

    PMID: 34013543RESULT

  • Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.

    PMID: 11222424RESULT

  • Taurchini M, Del Naja C, Tancredi A. Enhanced Recovery After Surgery: a patient centered process. J Vis Surg. 2018 Feb 27;4:40. doi: 10.21037/jovs.2018.01.20. eCollection 2018.

    PMID: 29552522RESULT

  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PMID: 28097305RESULT

  • Kehlet H. [Fast-track surgery: the facts and the challenges]. Cir Esp. 2006 Oct;80(4):187-8. doi: 10.1016/s0009-739x(06)70955-1. No abstract available. Spanish.

    PMID: 17040666RESULT

  • Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.

    PMID: 21468643RESULT

  • Brindle ME, Heiss K, Scott MJ, Herndon CA, Ljungqvist O, Koyle MA; on behalf Pediatric ERAS (Enhanced Recovery After Surgery) Society. Embracing change: the era for pediatric ERAS is here. Pediatr Surg Int. 2019 Jun;35(6):631-634. doi: 10.1007/s00383-019-04476-3. Epub 2019 Apr 25.

    PMID: 31025092RESULT

  • Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.

    PMID: 15635603RESULT

  • Roberts K, Brindle M, McLuckie D. Enhanced recovery after surgery in paediatrics: a review of the literature. BJA Educ. 2020 Jul;20(7):235-241. doi: 10.1016/j.bjae.2020.03.004. Epub 2020 May 6. No abstract available.

    PMID: 33456956RESULT

  • Bailey K, Choynowski M, Kabir SMU, Lawler J, Badrin A, Sugrue M. Meta-analysis of unplanned readmission to hospital post-appendectomy: an opportunity for a new benchmark. ANZ J Surg. 2019 Nov;89(11):1386-1391. doi: 10.1111/ans.15362. Epub 2019 Jul 30.

    PMID: 31364257RESULT

  • Hajibandeh S, Hajibandeh S, Bill V, Satyadas T. Meta-analysis of Enhanced Recovery After Surgery (ERAS) Protocols in Emergency Abdominal Surgery. World J Surg. 2020 May;44(5):1336-1348. doi: 10.1007/s00268-019-05357-5.

    PMID: 31897698RESULT

  • Sazhin AV, Nechay TV, Titkova SM, Tyagunov AE, Anurov MV, Melnikov-Makarchuk KY, Tyagunov AA, Ermakov IV, Glagolev NS, Kurashinova LS, Ivanova EA, Nechay VS, Karpov AV, Mirzoyan AT, Ivakhov GB, Balakirev YS. [Comparison of standard and fast track rehabilitation in patients with acute appendicitis. Intermediate results of multicenter prospective randomized trial]. Khirurgiia (Mosk). 2018;(9):15-23. doi: 10.17116/hirurgia2018090115. Russian.

    PMID: 30307416RESULT

  • Trejo-Avila ME, Romero-Loera S, Cardenas-Lailson E, Blas-Franco M, Delano-Alonso R, Valenzuela-Salazar C, Moreno-Portillo M. Enhanced recovery after surgery protocol allows ambulatory laparoscopic appendectomy in uncomplicated acute appendicitis: a prospective, randomized trial. Surg Endosc. 2019 Feb;33(2):429-436. doi: 10.1007/s00464-018-6315-9. Epub 2018 Jul 9.

    PMID: 29987566RESULT

  • 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: 31273450RESULT

  • Tlacuilo-Parra A, Lopez-Valenzuela SP, Ambriz-Gonzalez G, Guevara-Gutierrez E. [Seguridad y eficacia del modelo de atencion fast-track vs. atencion convencional en apendicitis no complicada del paciente pediatrico]. Cir Cir. 2018;86(5):412-416. doi: 10.24875/CIRU.18000189. Spanish.

    PMID: 30226494RESULT

  • Yu YR, Smith CM, Ceyanes KK, Naik-Mathuria BJ, Shah SR, Vogel AM, Carberry KE, Nuchtern JG, Lopez ME. A prospective same day discharge protocol for pediatric appendicitis: Adding value to a common surgical condition. J Pediatr Surg. 2017 Oct 9:S0022-3468(17)30633-4. doi: 10.1016/j.jpedsurg.2017.10.011. Online ahead of print.

    PMID: 29103787RESULT

  • Frazee R, Abernathy S, Davis M, Isbell T, Regner J, Smith R. Fast track pathway for perforated appendicitis. Am J Surg. 2017 Apr;213(4):739-741. doi: 10.1016/j.amjsurg.2016.08.006. Epub 2016 Oct 20.

    PMID: 27816201RESULT

  • Shbat L, Emil S, Elkady S, Baird R, Laberge JM, Puligandla P, Shaw K. Benefits of an abridged antibiotic protocol for treatment of gangrenous appendicitis. J Pediatr Surg. 2014 Dec;49(12):1723-5. doi: 10.1016/j.jpedsurg.2014.09.039. Epub 2014 Oct 11.

    PMID: 25487469RESULT

  • Lasso Betancor CE, Ruiz Hierro C, Vargas Cruz V, Orti Rodriguez RJ, Vazquez Rueda F, Paredes Esteban RM. [Implementation of "fast-track" treatment in paediatric complicated appendicitis]. Cir Pediatr. 2013 Apr;26(2):63-8. Spanish.

    PMID: 24228355RESULT

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Gabriela Ambriz, MD

    UMAE Pediatric Hospital CMNO IMSS

    STUDY DIRECTOR

Central Study Contacts

Ana Calderón, MD

CONTACT

6673152519anabe_calderon@hotmail.com

Gabriela Ambriz, MD

CONTACT

3339053703ggaby03@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient will be assigned to a control group or an experimental group based on simple random probabilistic sampling, using software (OxMaR: Oxford Minimization and Randomization, 2019) for minimization and randomization of clinical studies, single blind. A different postoperative treatment scheme will be applied for each of the groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial, single blind.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 22, 2022

Study Start

October 1, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Not required