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ERASNCT05465499

Preliminary Survey in Preparation for the Implementation of ERAS at Dr Soetomo Hospital

An observational study of ERAS, run by Dr. Soetomo General Hospital at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to analyze the readiness of the team that will support the ERAS application at Regional General Academic Hospital Dr Soetomo. Read more about this study

Who is it for?
Any age
Conditions the study is for
ERAS
What is being tested?
ERAS
Type of treatment
Surgery or procedure
How many people
207 participants
Where
1 siteIndonesia
Study dates
23 Mar 2022to 14 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who come to the anesthesiology polyclinic to prepare for SC surgery, simple urology, and simple orthopaedics.

Who may be able to join

  • Patients with elective cesarean, urology, and simple orthopaedic surgery plans
  • Patient with PS ASA 1-2

Who cannot join

  • Patients with communication disorders / mental disorders
  • Patients with outpatient surgery plans

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Dr Soetomo General Hospital

    Surabaya, East Java, 60286

Other trials in Indonesia

About this study

This study aims to analyze the readiness of the team that will support the ERAS application at Regional General Academic Hospital Dr Soetomo.

Read the detailed description

This is an observational analytic study with a cross-sectional design using a questionnaire. Patient baseline data were taken from the examination at the anesthesiology outpatient clinic. The patient's level of understanding was assessed by two investigators and rated on a scale of 1 to 5. Primary data and assessment of understanding of doctors and medical personnel were filled in independently by research subjects on online forms and rated on a scale of 1 to 5.

Conditions
ERAS
Being tested
ERAS
Keywords
ERAS, Intraoperative care, Perioperative care, Preoperative care, Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERASProcedure or surgery

    This study is a cross-sectional observational study by distributing questionnaires regarding the readiness to implement ERAS at Dr Soetomo General Hospital to the subjects, so there is no treatment whatsoever on the subjects.

Study groups in NCT05465499
Study groupRoleWhat they receive
PatientPatient baseline data were taken from the examination at the anesthesiology outpatient clinic. (N=41)
Receives: Procedure: ERAS
DoctorConsists of specialist and resident anesthesiology, orthopaedic surgery and traumatology, obstetrics and gynaecology, urology. (N=110)
Healthcare workerConsists of nutritionists, pharmacists, surgical nurses, anesthesiologists, and recovery room nurses.(N=56)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of understanding (using questionnaire)

    This outcome is reported by a score on a scale. The minimum value is one, and the maximum value is five. Higher scores mean better outcomes.

    Scale title:

    1. Strongly don't understand
    2. Don't understand
    3. Neutral
    4. Understand
    5. Strongly understand

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start23 Mar 2022
  3. Primary completion14 Apr 2022
  4. Study completion14 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05465499
Sponsor's protocol ID
0815/LOE/301.4.2/III/2022
Status last verified
Jul 2022
First submitted
12 Jul 2022
Last updated
19 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD able to be shared with other researchers with permission

Publications

  • Pache B, Hübner M, Martin D, Addor V, Ljungqvist O, Demartines N, et al. Requirements for a successful Enhanced Recovery After Surgery (ERAS) program: a multicenter international survey among ERAS nurses. Eur Surg - Acta Chir Austriaca 2021;53:246-50. https://doi.org/10.1007/s10353-021-00698-9.

  • Pedziwiatr M, Kisialeuski M, Wierdak M, Stanek M, Natkaniec M, Matlok M, Major P, Malczak P, Budzynski A. Early implementation of Enhanced Recovery After Surgery (ERAS(R)) protocol - Compliance improves outcomes: A prospective cohort study. Int J Surg. 2015 Sep;21:75-81. doi: 10.1016/j.ijsu.2015.06.087. Epub 2015 Jul 29.

    PubMed 26231994

  • Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30.

    PubMed 26514824

  • Geltzeiler CB, Rotramel A, Wilson C, Deng L, Whiteford MH, Frankhouse J. Prospective study of colorectal enhanced recovery after surgery in a community hospital. JAMA Surg. 2014 Sep;149(9):955-61. doi: 10.1001/jamasurg.2014.675.

    PubMed 25054315

  • Melnyk M, Casey RG, Black P, Koupparis AJ. Enhanced recovery after surgery (ERAS) protocols: Time to change practice? Can Urol Assoc J. 2011 Oct;5(5):342-8. doi: 10.5489/cuaj.11002.

    PubMed 22031616

  • Abeles A, Kwasnicki RM, Darzi A. Enhanced recovery after surgery: Current research insights and future direction. World J Gastrointest Surg. 2017 Feb 27;9(2):37-45. doi: 10.4240/wjgs.v9.i2.37.

    PubMed 28289508

  • Springer JE, Doumouras AG, Lethbridge S, Forbes S, Eskicioglu C. A Provincial Assessment of the Barriers and Utilization of Enhanced Recovery After Colorectal Surgery. J Surg Res. 2019 Mar;235:521-528. doi: 10.1016/j.jss.2018.10.047. Epub 2018 Nov 26.

    PubMed 30691838

  • Wang D, Liu Z, Zhou J, Yang J, Chen X, Chang C, Liu C, Li K, Hu J. Barriers to implementation of enhanced recovery after surgery (ERAS) by a multidisciplinary team in China: a multicentre qualitative study. BMJ Open. 2022 Mar 14;12(3):e053687. doi: 10.1136/bmjopen-2021-053687.

    PubMed 35288383

  • Polle SW, Wind J, Fuhring JW, Hofland J, Gouma DJ, Bemelman WA. Implementation of a fast-track perioperative care program: what are the difficulties? Dig Surg. 2007;24(6):441-9. doi: 10.1159/000108327. Epub 2007 Sep 13.

    PubMed 17851238

  • Ananda P, Semedi BP, Waloejo CS, Utariani A. Opioid-Sparring and Multimodal Analgesia as Parts of Enhanced Recovery After Surgery (ERAS) Applied In The Ksatria Airlangga Floating Hospital. Indones J Anesthesiol Reanim 2021;3:17. https://doi.org/10.20473/ijar.v3i12021.17-21.

  • Gramlich LM, Sheppard CE, Wasylak T, Gilmour LE, Ljungqvist O, Basualdo-Hammond C, Nelson G. Implementation of Enhanced Recovery After Surgery: a strategy to transform surgical care across a health system. Implement Sci. 2017 May 19;12(1):67. doi: 10.1186/s13012-017-0597-5.

    PubMed 28526041

  • Zychowicz A, Pisarska M, Laskawska A, Czyz M, Witowski J, Kisielewski M, Kulawik J, Budzynski A, Pedziwiatr M. Patients' opinions on enhanced recovery after surgery perioperative care principles: a questionnaire study. Wideochir Inne Tech Maloinwazyjne. 2019 Jan;14(1):27-37. doi: 10.5114/wiitm.2018.77261. Epub 2018 Jul 24.

    PubMed 30766626

  • Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

    PubMed 30426190

  • Feng J, Li K, Xu R, Feng H, Han Q, Ye H, Li F. Association between compliance with enhanced recovery after surgery (ERAS) protocols and postoperative outcome in patients with primary liver cancer undergoing hepatic resection. J Cancer Res Clin Oncol. 2022 Nov;148(11):3047-3059. doi: 10.1007/s00432-021-03891-1. Epub 2022 Jan 25.

    PubMed 35075571

  • Rodriguez-Laiz GP, Melgar-Requena P, Alcazar-Lopez CF, Franco-Campello M, Villodre-Tudela C, Pascual-Bartolome S, Bellot-Garcia P, Rodriguez-Soler M, Miralles-Macia CF, Mas-Serrano P, Navarro-Martinez JA, Martinez-Adsuar FJ, Gomez-Salinas L, Jaime-Sanchez FA, Perdiguero-Gil M, Diaz-Cuevas M, Palazon-Azorin JM, Such-Ronda J, Lluis-Casajuana F, Ramia-Angel JM. Fast-Track Liver Transplantation: Six-year Prospective Cohort Study with an Enhanced Recovery After Surgery (ERAS) Protocol. World J Surg. 2021 May;45(5):1262-1271. doi: 10.1007/s00268-021-05963-2. Epub 2021 Feb 23.

    PubMed 33620540

Questions about this trial

What is this clinical trial studying?

An observational study of ERAS, run by Dr. Soetomo General Hospital at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of understanding (using questionnaire) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05465499, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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