Trial Title:
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes
NCT ID:
NCT05518643
Condition:
ERAS
Pancreas Cancer
Pancreas; Fistula
Delayed Gastric Emptying
Surgery-Complications
Pancreatic Hemorrhage
PROMs
Conditions: Official terms:
Pancreatic Neoplasms
Gastroparesis
Pancreatic Fistula
Hemorrhage
Fistula
Conditions: Keywords:
ERAS
Pancreas Cancer
PROMs
Stress response to surgery
Surgery-Complications
PLR
NLR
Quality of Life
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
ERAS protocol
Description:
ERAS protocol as described above
Summary:
The purpose of this study is to evaluate the impact of compliance with enhanced recovery
after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific
outcomes and stress response after pancreatic surgery.
This prospective observational study will include all consecutive patients undergoing
pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely
University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be
prospectively enrolled after written informed consent. Data will be collected on patient
characteristics, surgical and anaesthetic techniques, complications, and length of stay.
Quality of life questionnaires will be administered to patients preoperatively, on the
fith postoperative day, first follow-up after discharge, one month and six months after
the operation. The stress response will be assessed by measuring the
Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively,
and on the first five postoperative days. Data will be collected on pancreatic
surgery-specific complications such as delayed gastric emptying (DGE),
post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF)
formation. Anonymised data will be uploaded by the principal investigator on a protected
excel spreadsheet for analysis.
Detailed description:
In this study the ERAS program is applied to patients undergoing pancreatic surgery.This
is a prospective observational cohort study.The study will take place in two hospitals,
the University General Hospital of Larissa (academic center), and IASO Thessalias
(largest private general hospital in Thessaly). The study period is three years between
May 2022 and April 2025. All patients undergoing pancreatic surgery during this period
will be invited to participate in the study. Recruitment will take place at the first
appointment with the surgeon when the patient is listed for surgery. The patient will be
provided with detailed information about the program which also includes an information
leaflet. A written consent form will be signed by patients willing to participate in the
study.
Enrolled patients will follow the ERAS pathway for pancreatic surgery during the
preoperative, intraoperative, and postoperative period. The ERAS protocol is based on
ERAS society recommendations for enhanced recovery after pancreatoduodenectomy.
The ERAS protocol consists of the following items:
First appointment preoperative:
- Patient education about the program
- Prehabilitation with advice on physical exercise and nutritional support
- Advice to stop smoking and alcohol consumption
- Plan for optimisation of comorbidities
- Completion of quality of life questionnaire
Day before surgery:
- Discussion about the program to address any patient concerns and anxieties
- Light meal and carbohydrate drink before bedtime
- Anti-clotting injection 12 hours before surgery
Day of surgery:
- Carbohydrate drink and painkillers 3 hours before surgery
- Clear fluids allowed up to 3 hours before surgery
- Antibiotics within 1 hour before surgical incision
Intraoperative
- Epidural catheter is sited before general anaesthesia
- Multimodal and opioid-sparing analgesia
- Nausea and vomiting prophylaxis
- Goal directed fluid therapy
- Active warming to avoid hypothermia
- Monitoring of blood glucose to maintain normoglycaemia
- Bile culture
- Repeat antibiotics if surgery lasts more than 4 hours
Postoperative:
- Removal of nasogastric tube by postoperative day 1
- Removal of drains by postoperative day 3
- Multimodal analgesia, epidural catheter for 3 days, minimisation of opioids
- Early and scheduled mobilisation and respiratory physiotherapy protocol
- Diet protocol with nutritional drinks and gradual progression from light to solid
diet by postoperative day 5
- Removal of urinary catheter when patients able to mobilise on their own, by
postoperative day 5
- Cessation of intravenous fluids when patients able to drink 1.5 liters of water, by
postoperative day 5
- Regular gastrokinetic medication and gum chewing
- Glycaemic control protocol
- Cessation of antibiotics if bile culture negative and no other indication to
continue
The study group will use a checklist with ERAS criteria to follow for each patient and
data will be collected on adherence rates to these criteria.
Data will be collected on patient demographics such as sex, age, Body Mass Index (BMI),
American Society of Anaesthesiologists (ASA) physical status, and co-morbidities. Data
will also be collected on surgical approach and technique, and tumour stage (pTNM). Data
will be collected on complications including cardiovascular and respiratory
complications, infectious complications (surgical site infection, chest infection,
urinary tract infection, intra-abdominal abscess, sepsis), anaesthetic complications
(severe pain, delirium, cognitive decline), functional complications (functional decline,
new mobility aid use, pressure ulcer, discharge to nursing or rehabilitation facility),
renal failure, ileus, return to theatre, readmission, and death. Data will be collected
on length of stay and pancreatic surgery-specific complications such as DGE, PPH and POPF
formation. International consensus guidelines will be used for definition and grading of
these complications.
Quality of life will be assessed by Patient Reported Outcome Measures (PROMS). The stress
response will be assessed by measuring NLR and PLR. After anonymization, all data will be
prospectively uploaded by local investigators on a protected database and incorporated
into a spreadsheet for data analysis.
The data will be analyzed using PROMs, NLR and PLR ratios, postoperative complications,
length of hospital stay and cancer recurrence rates as the main outcome variables.The
influence of the following factors will be assessed: age, BMI, sex, surgical technique,
pTNM stage, preoperative comorbidity, ASA classification, previous SARS-CoV-2 infection,
and compliance to the ERAS protocol (<50%, 50-70%, 70-90%, >90%). Adherence will be
calculated as the number of interventions fulfilled/20 (total number of preoperative and
perioperative interventions).
The statistical model will be multivariate regression analysis. Sample size guidelines
for observational studies with regression analysis are based on simulation studies and
suggest that the minimum number of events per variable (EPV) should be 10. According to
these guidelines the minimum sample size is calculated at 90. To account for 25% loss to
follow-up the investigators aim for a total enrollment goal of 120 participants. IBM®
SPSS 26 software will be used for statistical analysis. Continuous variables will be
compared with One-Way ANOVA or Student's t test for parametric data and with a
non-parametric test (Mann-Whitney U test or Kruskal-Wallis test), as indicated.
Categorical data will be analysed by using the chi squared or Fisher's exact test where
indicated. Quantitative values will be expressed as mean ± standard deviation (SD),
median and range, categorical data with percentage frequencies. The odds ratio (OR) will
be presented followed by 95% confidence interval (95% CI). Differences in survival and
complications between different degrees of compliance will be assessed by the application
of log rank test. P < 0.05 will be considered statistically significant.
Criteria for eligibility:
Study pop:
All consecutive community patients presented for pancreatic surgery
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- all pancreatic surgery patients
- above the age of 18
- fluent greek speakers
- without communication barriers
Exclusion Criteria:
- younger than 18 years-old
- unable or unwilling to participate
- other surgical procedures
- communication barriers
- lost to follow-up
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Thessaly
Address:
City:
Larissa
Zip:
45100
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Despoina Liotiri, Consultant
Phone:
00306947941422
Email:
deppieliotiri@gmail.com
Investigator:
Last name:
Alexandros Diamantis, Consultant
Email:
Sub-Investigator
Investigator:
Last name:
Eleni Siwka, Consultant
Email:
Sub-Investigator
Investigator:
Last name:
Ismini Paraskeva, Trainee
Email:
Sub-Investigator
Start date:
July 15, 2022
Completion date:
August 2026
Lead sponsor:
Agency:
University of Thessaly
Agency class:
Other
Collaborator:
Agency:
IASO Thessalias
Agency class:
Other
Collaborator:
Agency:
Larissa University Hospital
Agency class:
Other
Source:
University of Thessaly
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518643
