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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05465499
Other study ID # 0815/LOE/301.4.2/III/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2022
Est. completion date April 14, 2022

Study information

Verified date July 2022
Source Dr. Soetomo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date April 14, 2022
Est. primary completion date April 14, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with elective cesarean, urology, and simple orthopaedic surgery plans - Patient with PS ASA 1-2 Exclusion Criteria: - Patients with communication disorders / mental disorders - Patients with outpatient surgery plans

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ERAS
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.

Locations

Country Name City State
Indonesia Dr Soetomo General Hospital Surabaya East Java

Sponsors (1)

Lead Sponsor Collaborator
Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (16)

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. Review. — View Citation

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.

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, Ytrebø 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. Review. — View Citation

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 Jan 25. doi: 10.1007/s00432-021-03891-1. [Epub ahead of print] — View Citation

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. — View Citation

Gillis C, Gill M, Marlett N, MacKean G, GermAnn K, Gilmour L, Nelson G, Wasylak T, Nguyen S, Araujo E, Zelinsky S, Gramlich L. Patients as partners in Enhanced Recovery After Surgery: A qualitative patient-led study. BMJ Open. 2017 Jun 24;7(6):e017002. doi: 10.1136/bmjopen-2017-017002. — View Citation

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. — View Citation

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(®)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y. Review. — View Citation

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. — View Citation

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®) 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. — View Citation

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. Epub 2007 Sep 13. — View Citation

Rodríguez-Laiz GP, Melgar-Requena P, Alcázar-López CF, Franco-Campello M, Villodre-Tudela C, Pascual-Bartolomé S, Bellot-García P, Rodríguez-Soler M, Miralles-Maciá CF, Más-Serrano P, Navarro-Martínez JA, Martínez-Adsuar FJ, Gómez-Salinas L, Jaime-Sánchez FA, Perdiguero-Gil M, Díaz-Cuevas M, Palazón-Azorín JM, Such-Ronda J, Lluís-Casajuana F, Ramia-Ángel 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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:
Strongly don't understand
Don't understand
Neutral
Understand
Strongly understand
1 month
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