Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
Primary Purpose
Pancreatic Neoplasms, Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multimodal Prehabilitation
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Neoplasms
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.
Sites / Locations
- Hospital Clinic de BarcelonaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prehabilitation
Arm Description
Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery.
Outcomes
Primary Outcome Measures
Efficacy of a multimodal prehabilitation
To evaluate the efficacy of a multimodal prehabilitation program in high risk surgical patients undergoing oncological resection of the pancreas in terms of improvement in aerobic capacity (peak oxygen consumption, anaerobic threshold) measured through a CPET.
Secondary Outcome Measures
Evaluation of the adherence to the program
Assess the % of sessions that the patient has completed
Evaluation of sarcopenia after prehabilitation
Sarcopenia analyzed objectively with a CT scan.
Evaluation of the impact on perceived quality of life
Evaluation of the impact of the program in patient quality of life according EuroQol (Qual Life Res. 1999 ;8:303-10)
Evaluation of the impact on the inflammatory response after the intervention
Presence or abscence of Systemic Inflammatory Response Syndrome (SIRS) during the preoperative period. SIRS defined by two of the following criteria: Body temperature over 38 or under 36 degrees Celsius.
Heart rate greater than 90 beats/minute Respiratory rate greater than 20 breaths/minute or partial pressure of CO2 less than 32 mmHg Leucocyte count greater than 12000 or less than 4000 /microliters or over 10% immature forms or bands.
Evaluation of the impact on the incidence of postoperative complications
Incidence of complications
Evaluation of complications severity
Complications according Clavien-Dindo Classification
Full Information
NCT ID
NCT05489419
First Posted
July 4, 2022
Last Updated
August 3, 2022
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT05489419
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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).
Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal Prehabilitation
Intervention Description
Physical and cardiopulmonary training, personalized nutrition and treatment of anxiety and depression.
Primary Outcome Measure Information:
Title
Efficacy of a multimodal prehabilitation
Description
To evaluate the efficacy of a multimodal prehabilitation program in high risk surgical patients undergoing oncological resection of the pancreas in terms of improvement in aerobic capacity (peak oxygen consumption, anaerobic threshold) measured through a CPET.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the adherence to the program
Description
Assess the % of sessions that the patient has completed
Time Frame
30 days
Title
Evaluation of sarcopenia after prehabilitation
Description
Sarcopenia analyzed objectively with a CT scan.
Time Frame
4 weeks
Title
Evaluation of the impact on perceived quality of life
Description
Evaluation of the impact of the program in patient quality of life according EuroQol (Qual Life Res. 1999 ;8:303-10)
Time Frame
4 weeks
Title
Evaluation of the impact on the inflammatory response after the intervention
Description
Presence or abscence of Systemic Inflammatory Response Syndrome (SIRS) during the preoperative period. SIRS defined by two of the following criteria: Body temperature over 38 or under 36 degrees Celsius.
Heart rate greater than 90 beats/minute Respiratory rate greater than 20 breaths/minute or partial pressure of CO2 less than 32 mmHg Leucocyte count greater than 12000 or less than 4000 /microliters or over 10% immature forms or bands.
Time Frame
30 days
Title
Evaluation of the impact on the incidence of postoperative complications
Description
Incidence of complications
Time Frame
30 days
Title
Evaluation of complications severity
Description
Complications according Clavien-Dindo Classification
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol González, MD
Phone
+34638725100
Email
carol.gonzaleza@gmail.com
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol González, MD
Phone
+34638725100
Email
carol.gonzaleza@clinic.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
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