An interventional study of Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery in Gynecologic Surgical Procedures and Enhanced Recovery After Surgery, sponsored by Instituto Brasileiro de Controle do Cancer. Withdrawn at 1 site in Brazil. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Instituto Brasileiro de Controle do Cancer · Not applicable, Interventional, and Treatment
Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
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 (ERAS®) guidelines will be applied.
Instituto Brasileiro de Controle do Cancer is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
Other: Prehabilitation Program + Enhanced Recovery After Surgery
Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
Other: Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Also known as: Prehabilitation + ERAS
ERAS protocol
Also known as: ERAS
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
Time frame: Up to 30 postoperative days
Complications
Clavien-Dindo Classification, Grades I-V
Time frame: Up to 30 postoperative days
Readmissions
Readmission to the Hospital Facilities
Time frame: Up to 30 postoperative days
Intensive Care Unit admission rates
Postoperative Intensive Care Unit admission and stay
Time frame: 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)
Time frame: At Baseline, then at 30 and 60 days postoperatively
Compliance to the ERAS® program guidelines
Compliance to ERAS® protocol and implementation of the program
Time frame: Through study completion, an average of 1 year
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.
Time frame: Baseline and postoperatively at 30 and 60 days
Changes in functional capacity from baseline
Patients will perform a 6-Minute Walk Test
Time frame: Baseline and postoperatively at 30 and 60 days
Change in muscle strength
Muscle strength is measured by using an dynamometer
Time frame: Baseline and postoperatively at 30 and 60 days
Change in body mass
Body mass is measured by using a bioelectrical impedance analysis
Time frame: Baseline and postoperatively at 30 and 60 days
Hospital stay
Days from surgical procedure to hospital discharge
Time frame: Up to 30 days
Plan to share: Yes — After publication of the results
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Instituto Brasileiro de Controle do Cancer