Clinical trial · Interventional
Prehabilitation in Esophageal Surgery (PRESS)
Evaluation of a Multimodal Program of Prehabilitation in Patients Undergoing Esophagectomy Within an ERAS Pathway
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated prematurely due to slow recruitment.
Summary
Brief summary (as posted)
Despite important clinical improvements, esophageal cancer surgery is still associated to a high rate of postoperative complications. Recent ERAS (Enhanced Recovery After Surgery) Society guidelines underline the possible role of prehabilitations' programs in reducing postoperative morbidity. In this trial, 200 patients, scheduled for esophageal cancer resection, will be randomly assigned to two groups (100 patients for each group). In both groups, patients will perform a basal evaluation with a physiotherapist, a nutritionist and a psychologist. In the treatment group, each patient will receive a tailored prehabilitative program and, during the 4 weeks before surgery, will be monitored constantly by each single specialist. A preoperative revaluation (the day before surgery) and follow up visits at 3 and 6 months will be performed for all patients. The incidence of postoperative complications, the length of hospital stay, and the reach of discharge criteria will be registered.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation program
- description
- The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient. The program will have a duration of, at least, 4 weeks.
- interventionNames
- Other: Prehabilitation
- type
- NO_INTERVENTION
- label
- Control
- description
- The patients included in this group will, also, receive a basal evaluation by a physiotherapist, a nutritionist and a psychologist. These patients will not receive a tailored prehabilitation program and will be revaluated the day before surgery.
Primary outcomes (1)
- measure
- Post-operative complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent; * Patients scheduled for Esophageal cancer resection with Ivor-lewis technique; * Previous CT/RT neoadjuvant treatment; * Possibility to perform a prehabilitation treatment of, at least, 4 weeks. Exclusion Criteria: * Patient refusal * Comorbid medical, physical, and mental conditions that contraindicate exercise or oral nutrition.
References
Publications (6)
- BACKGROUNDLow DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4. PMID 30276441
- BACKGROUNDMinnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645. PMID 30193337
- BACKGROUNDMinnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30. PMID 29754828
- BACKGROUNDStratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258. PMID 15533269
- BACKGROUNDMohri Y, Inoue Y, Tanaka K, Hiro J, Uchida K, Kusunoki M. Prognostic nutritional index predicts postoperative outcome in colorectal cancer. World J Surg. 2013 Nov;37(11):2688-92. doi: 10.1007/s00268-013-2156-9. PMID 23884382
- BACKGROUNDArends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. PMID 27637832