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The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.
Main objective: To determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer).
Design: Multicenter randomized controlled clinical trial. Subjects: 146 patients: 73 in the intervention group and 73 in the control group.
Intervention group: PreHAB intervention consists on:
Measures: Aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Control group will follow the standard preoperative measures "Enhanced Recovery After Surgery" (ERAS®) established in the protocols of our hospital. Standard preoperative measures: recommendation of nutritional and physical activity and advice to stop smoking and reduce alcohol intake; optimization of preoperative pathologies including anaemia. An information document on ERAS® measures in our center will be attached to all of them. | |
| Multimodal prehabilitation | Experimental | Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Prehabilitation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative complications | Any deviation from the normal postoperative course and according its severity to the Clavien-Dindo classification, will be considered a complication. A comprehensive complication index (CCI) scale will be used which assigns a value to each Clavein-Dindo level so a weighted average of the severity of complications can be calculated not only in a qualitatively way, but also numerically. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital and ICU (intensive care unit) length of stay | postoperative 30 days | |
| Compliance to the ERAS program. | Percentage of items of ERAS program that were completed. Key aspects of this protocol include prevention of prolonged fasting allowing oral intake of clear fluids up to 2 hours before induction of anaesthesia, carbohydrate loading, avoidance of mechanical bowel preparation except if a bowel resection is scheduled, thromboprophylaxis; pre-, intra-, and post-operative euvolemia via goal directed fluid therapy, maintenance of normothermia, intraoperative and postoperative opioid-sparing multi-modal analgesia, avoidance the use of surgical drains, early removal of the urine catheter, and an emphasis on early ambulation and feeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berta Diaz-Feijoo, MD PHD | Hospital Clinic of Barcelona | Principal Investigator |
| M Jose Arguis, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Barcelona | Barcelona | Barcelona | 08036 | Spain | ||
| Biomedical Research Institute la Fe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 35793862 | Derived |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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|
| postoperative 30 days |
| Interval of days between surgery and the start of chemotherapy | From date of surgery up to 6 months |
| Preoperative and postoperative aerobic capacity | Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise. | baseline, 1 and 3 month post intervention |
| Cost-effectiveness | Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery. | Baseline up to 30 days after surgery |
| Health Related Quality of Life assesed by EORTC QLC-C30 | Baseline and 1 month postoperative |
| Incidence of cognitive deficit | Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition) | Baseline and 1 month postoperative |
| Overall and disease-free survival of the study groups | 5 years |
| Nutritional status | GLIM (includes hand-grip) | Baseline and 1 month postoperative |
| Valencia |
| Valencia |
| 46026 |
| Spain |
| Diaz-Feijoo B, Agusti N, Sebio R, Siso M, Carreras-Dieguez N, Domingo S, Diaz-Cambronero O, Torne A, Martinez-Palli G, Arguis MJ. A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE). Int J Gynecol Cancer. 2022 Nov 7;32(11):1463-1468. doi: 10.1136/ijgc-2022-003652. |