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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04505111
Other study ID # 08304219.8.0000.0072
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 23, 2020
Est. completion date October 1, 2020

Study information

Verified date April 2022
Source Instituto Brasileiro de Controle do Cancer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.


Description:

Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or suspicious gynaecological cancer, who will undergo gynaecological surgery. The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, the protocol and specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERASĀ®) guidelines will be applied.


Recruitment information / eligibility

Status Withdrawn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

Study Design


Intervention

Other:
Prehabilitation Program + Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Enhanced Recovery After Surgery
ERAS protocol

Locations

Country Name City State
Brazil IBCC - Instituto Brasileiro de Controle do Cancer São Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí 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

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — 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. — View Citation

Miralpeix E, Mancebo G, Gayete S, Corcoy M, Solé-Sedeño 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. Review. — 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®) 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

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. Review. — View Citation

Outcome

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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