Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial
PROPER
Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial
1 other identifier
interventional
194
1 country
1
Brief Summary
Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2020
Typical duration for phase_3
1 active site
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
October 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 31, 2023
October 1, 2023
3.9 years
October 18, 2020
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative recovery time
Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs
Up to 30 postoperative days
Secondary Outcomes (11)
Complications and Adverse Effects
Up to 30 postoperative days
Readmissions
Up to 30 postoperative days
Intensive Care Unit admission rates
Up to 30 postoperative days
Health-related Quality of Life
At Baseline, the week before surgery, then at postoperative days 7, 30 and 60
Compliance to the ERAS® program guideline
Up to 30 postoperative days
- +6 more secondary outcomes
Study Arms (2)
Prehabilitation + Enhanced Recovery After Surgery
EXPERIMENTALPatients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
Enhanced Recovery After Surgery
ACTIVE COMPARATORPatients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
Interventions
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Eligibility Criteria
You may qualify if:
- Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
- 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
You may not qualify if:
- Patients under 18 or older than 80 years old;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Brasileiro de Controle do Cancer - IBCC
São Paulo, Brazil
Related Publications (10)
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.
PMID: 25076007BACKGROUNDSanta 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.
PMID: 24439570BACKGROUNDBarberan-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.
PMID: 28489682BACKGROUNDNelson 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.
PMID: 26603969BACKGROUNDNelson 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.
PMID: 26757238BACKGROUNDNelson 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.
PMID: 30877144BACKGROUNDLauretani 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.
PMID: 14555665BACKGROUNDIyer 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.
PMID: 25535730BACKGROUNDMiralpeix 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.
PMID: 31473663BACKGROUNDLopes 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.
PMID: 34750197DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre Lopes, MD
Instituto Brasileiro de Controle do Cancer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Single-Blind (surgeons and anesthesiologists)
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 18, 2020
First Posted
October 22, 2020
Study Start
November 5, 2020
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After study enrollment
- Access Criteria
- Public
After publication of the results