Clinical trial NCT05489419: Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
Official title: Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Anesthesia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery.

Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients.

Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include:

1. Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT).
2. Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
3. Treatment of anxiety and depression.

Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period.

Analysis:

The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.


Eligibility criteria: Inclusion Criteria:

* Adult patients eligible for pancreatic surgery (PD) who are considered high risk based on the findings of the CPET (anaerobic threshold, AU \<11ml/kg/min) (Older P et al. Crit Care. 2004;8:369-72) and accepted as candidates for said surgery by the multidisciplinary committee of our Institution.

Exclusion Criteria:

* Non-elective surgery;
* Palliative surgery;
* Unstable respiratory or cardiac disease;
* Locomotor or cognitive limitations that prevent adherence to the program;
* Refusal to participate in the study.

Primary outcomes:
measure: Efficacy of a multimodal prehabilitation
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation of the adherence to the program
timeFrame: 30 days
measure: Evaluation of sarcopenia after prehabilitation
timeFrame: 4 weeks
measure: Evaluation of the impact on perceived quality of life
timeFrame: 4 weeks
measure: Evaluation of the impact on the inflammatory response after the intervention
timeFrame: 30 days
measure: Evaluation of the impact on the incidence of postoperative complications
timeFrame: 30 days
measure: Evaluation of complications severity
timeFrame: 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References: