Enhanced Recovery After Surgery Clinical Trial
Official title:
Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery
Verified date | April 2022 |
Source | Instituto Brasileiro de Controle do Cancer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2020 |
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 locomotion 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; - Non-adherence of the patient in the intervention group to the preoperative prehabilitation program. - If surgery is performed 21 days after the last day of the prehabilitation program, for any reason |
Country | Name | City | State |
---|---|---|---|
Brazil | IBCC - Instituto Brasileiro de Controle do Cancer | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto Brasileiro de Controle do Cancer |
Brazil,
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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®) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. — 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®) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. — 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
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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 | Clavien-Dindo Classification, Grades I-V | 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, then at 30 and 60 days postoperatively | |
Secondary | Compliance to the ERAS® program guidelines | Compliance to ERASĀ® protocol and implementation of the program | Through study completion, an average of 1 year | |
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. | Baseline and postoperatively at 30 and 60 days | |
Secondary | Changes in functional capacity from baseline | Patients will perform a 6-Minute Walk Test | Baseline and postoperatively at 30 and 60 days | |
Secondary | Change in muscle strength | Muscle strength is measured by using an dynamometer | Baseline and postoperatively at 30 and 60 days | |
Secondary | Change in body mass | Body mass is measured by using a bioelectrical impedance analysis | Baseline and postoperatively at 30 and 60 days | |
Secondary | Hospital stay | Days from surgical procedure to hospital discharge | Up to 30 days |
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