Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial
NCT ID: NCT04596800
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
194 participants
INTERVENTIONAL
2020-11-05
2024-12-31
Brief Summary
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Detailed Description
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The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Prehabilitation + Enhanced Recovery After Surgery
Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
Prehabilitation Program + Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Enhanced Recovery After Surgery
Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
Enhanced Recovery After Surgery
ERAS
Interventions
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Prehabilitation Program + Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Enhanced Recovery After Surgery
ERAS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women aged between 18 and 80 years old;
* Gynecological surgery performed by laparotomy;
* Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
* Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks
Exclusion Criteria
* ECOG ≥3;
* Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
* Limitation of ambulation preventing the patient to perform physical exercises;
* Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
* Emergency or urgency surgeries;
* Surgeries by minimally invasive approach (laparoscopy or robotics);
* Vulvectomy or soft tissue surgery without abdominal approach;
* Minor gynaecological surgeries such as conizations;
* Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
* If surgery is performed 21 days after the last day of the prehabilitation program, for any reason
18 Years
80 Years
FEMALE
Yes
Sponsors
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Instituto Brasileiro de Controle do Cancer
OTHER
Responsible Party
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André Lopes
MD
Principal Investigators
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Andre Lopes, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Brasileiro de Controle do Cancer
Locations
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Instituto Brasileiro de Controle do Cancer - IBCC
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.
Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.
Lopes A, Yamada AMTD, Cardenas TC, Carvalho JN, Oliveira EA, Silva MERD, Andrade JFM, de Souza Neto E, Barros LADR, Costa RLR. PROPER-PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial. Int J Gynecol Cancer. 2022 Feb;32(2):195-197. doi: 10.1136/ijgc-2021-003170. Epub 2021 Nov 8.
Other Identifiers
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36924620.7.0000.0072
Identifier Type: -
Identifier Source: org_study_id
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