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Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
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 (ERASĀ®) guidelines will be applied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation + Enhanced Recovery After Surgery | Experimental | Patients 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 Comparator | Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERASĀ®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation Program + Enhanced Recovery After Surgery | Other | Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications and Adverse Effects | Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017 | Up to 30 postoperative days |
| Readmissions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre Lopes, MD | Contact | +551134744242 | andrelopes.cirurgia@gmail.com | |
| Alayne Yamada, PhD | Contact | +551134744242 | alayne.pesquisa@ibcc-mooca.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Andre Lopes, MD | Instituto Brasileiro de Controle do Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Brasileiro de Controle do Cancer - IBCC | Recruiting | SĆ£o Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25076007 | Background | 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. | |
| 24439570 | Background |
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After publication of the results
After study enrollment
Public
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Single-Blind (surgeons and anesthesiologists)
|
| Enhanced Recovery After Surgery | Other | ERAS |
|
|
Readmission to the Hospital Facilities
| Up to 30 postoperative days |
| Intensive Care Unit admission rates | Postoperative Intensive Care Unit admission and stay | Up to 30 postoperative days |
| Health-related Quality of Life | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 |
| Compliance to the ERASĀ® program guideline | Compliance to ERASĀ® protocol and implementation of the program | Up to 30 postoperative days |
| Changes in anxiety and depression from baseline | Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological. | At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 |
| Changes in functional capacity from baseline | Patients will perform a 6-Minute Walk Test | At Baseline, the week before surgery, then at postoperative days 30 and 60 |
| Change in muscle strength | Muscle strength is measured by using an dynamometer | At Baseline, the week before surgery, then at postoperative days 30 and 60 |
| Change in body mass | Body mass is measured by using a bioelectrical impedance analysis | At Baseline, the week before surgery, then at postoperative days 30 and 60 |
| Hospital stay | Days from surgical procedure to hospital discharge | Up to 30 days |
| Use of opioids in acute postoperative pain | Use and dosage of opioids in the postoperative period | Up to 30 days |
| 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. |
| 28489682 | Background | 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. |
| 26603969 | Background | 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. |
| 26757238 | Background | 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. |
| 30877144 | Background | 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. |
| 14555665 | Background | 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. |
| 25535730 | Background | 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. |
| 31473663 | Background | 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. |
| 34750197 | Derived | 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. |
| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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