Gynecologic Cancer Clinical Trial
— PROPEROfficial title:
Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial
Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Status | Recruiting |
Enrollment | 194 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Brasileiro de Controle do Cancer - IBCC | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto Brasileiro de Controle do Cancer |
Brazil,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Readmissions | Readmission to the Hospital Facilities | Up to 30 postoperative days | |
Secondary | Intensive Care Unit admission rates | Postoperative Intensive Care Unit admission and stay | Up to 30 postoperative days | |
Secondary | 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 | |
Secondary | Compliance to the ERAS® program guideline | Compliance to ERASĀ® protocol and implementation of the program | Up to 30 postoperative days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Hospital stay | Days from surgical procedure to hospital discharge | Up to 30 days | |
Secondary | Use of opioids in acute postoperative pain | Use and dosage of opioids in the postoperative period | Up to 30 days |
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