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Clinical trial
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)
  1. Berta Díaz-Feijoo1,2,3,
  2. Nuria Agusti1,3,
  3. Raquel Sebio1,4,
  4. Marina Sisó1,5,
  5. Núria Carreras-Dieguez1,3,
  6. Santiago Domingo6,
  7. Oscar Díaz-Cambronero7,
  8. Aureli Torne1,2,3,
  9. Graciela Martinez-Palli1,8 and
  10. Ma José Arguís1,8
  1. 1Hospital Clinic de Barcelona, Barcelona, Spain
  2. 2Universitat de Barcelona, Barcelona, Spain
  3. 3Department of Gynecologic Oncology, Hospital Clinic de Barcelona, Barcelona, Spain
  4. 4Department of Rehabilitation, Hospital Clinic de Barcelona, Barcelona, Spain
  5. 5Nutrition and Clinical Dietetics, Hospital Clinic de Barcelona, Barcelona, Spain
  6. 6Gynaecology, Hospital Politécnico y Universitario La Fe, Valencia, Spain
  7. 7Department of Anesthesiology and Critical Care, Hospital Universitari i Politecnic La Fe, Valencia, Spain
  8. 8Anaesthesiology and Intensive Care, Hospital Clinic de Barcelona, Barcelona, Spain
  1. Correspondence to Dr Berta Díaz-Feijoo, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain; bdiazfe{at}clinic.cat

Abstract

Background Multimodal prehabilitation programs that combine exercise training, nutritional support, and optimize psychological status have demonstrated efficacy in reducing post-operative complications in non-gynecological abdominal surgeries; however, the benefit in advanced ovarian cancer is unclear.

Primary Objective To compare the post-operative complications of a multimodal prehabilitation program in patients undergoing cytoreductive surgery for advanced ovarian cancer with standard pre-operative care.

Study Hypothesis Multimodal prehabilitation reduces post-operative complications in patients undergoing cytoreductive surgery for advanced ovarian cancer and subsequently reduces the length of hospital stay and time to initiation of adjuvant therapy.

Trial Design This prospective, multi-institutional, randomized clinical trial will randomize candidates for surgery to either the standard of care or multimodal prehabilitation consisting of (1) 2- or 3-weekly supervised high-intensity resistance training sessions and promotion of physical activity through a mobile phone application; (2) respiratory physiotherapy; (3) nutrition counseling with supplementation as needed; and (4) weekly psychological and cognitive behavioral sessions. Baseline, pre-operative and 1 month post-operative data will be collected. An independent blinded evaluator will collect intra- and post-operative surgical data.

Major Inclusion/Exclusion Criteria Women with advanced ovarian cancer International Federation of Gynecology and Obstetrics (2014) stage III or IV scheduled to undergo primary debulking surgery, interval debulking surgery,or secondary or tertiary cytoreductive surgery will be included. Women are eligible if they are able to undergo a minimum of 2 weeks of prehabilitation prior to surgery. Patients with <75% adherence to the total program will be excluded.

Primary Endpoint Post-operative complications in patients with advanced ovarian cancer undergoing cytoreductive surgery according to the Comprehensive Complication Index.

Sample Size 146 patients will be included, 73 in each group.

Estimated Dates for Completing Accrual and Presenting Results Accrual should be completed in December 2024 with results reported soon thereafter.

Trial Registration Number NCT04862325.

  • ovarian cancer
  • cytoreduction surgical procedures
  • postoperative complications
  • preoperative care
  • postoperative care

Data availability statement

Data are available upon request.

https://doi.org/10.1136/ijgc-2022-003652

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    Data availability statement

    Data are available upon request.

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    Footnotes

    • BD-F and NA are joint first authors.

    • BD-F and NA contributed equally.

    • Correction notice This article has been corrected since it was first published to indicate joint first authorship.

    • Collaborators Hospital Clínic de Barcelona Prehabilitation Group: Graciela Martínez-Pallí, Marta Ubré, Raquel Risco, Manuel López-Baamonde, Antonio López, María José Arguis, Ricard Navarro-Ripoll, Mar Montané-Muntané, Marina Sisó, Raquel Sebio, Monique Messaggi-Sartor, Fernando Dana, David Capitán, Amaya Peláez Sainz-Rasines, Beatriz Tena, Betina Campero, Bárbara Romano-Andrioni, Silvia Terés, Elena Gimeno-Santos, Eurídice Álvaro and Juan M Perdomo.

    • Contributors BD-F: Guarantor, conceptualization, project development, data collection, data analysis, investigation, project administration and writting revision. NA:Guarantor, conceptualization, project development, data collection, data analysis, project administration and manuscript writing. SD, NC-D, AT: Project development and data collection. RS and AL: Physical activity program conceptualization and project supervision. MS: Nutritional program conceptualitzation and supervision. OD-C: Physical activity program conceptualization, project development and data collection. GM-P and MJA: Physical activity program conceptualization, project development and data collection. All authors provided critical feedback and helped shape the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Commissioned; internally peer reviewed.