Expectation, Pain Outcomes, and Pain Medication Following Oncology Abdominal Surgery: A Cohort Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
This study includes participants undergoing major hepatic surgery, surgery in the esophagus or stomach, or major surgery on the pancreas performed at Copenhagen University Hospital, Rigshospitalet. The aims of the study 1: To record patients' level of catastrophizing preoperatively and pain perioperatively, and pain treatment, as well as related side effects. Furthermore, to investigate whether it is possible to assign the task of rating pain scores to the patient.
2\. To investigate patients' expectations preoperatively and the fulfillment of these expectations 30 days after, and the development of chronic pain after 6 months. 3. To record patients' pre- and postoperatively rated health and daily quality of recovery during the seven days of admission. Furthermore, patients' symptoms, levels of pain, and use of analgesics will be assessed 30 days and six months after discharge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients > 18 years undergoing elective surgical treatment in the liver, esophagus/cardia, or pancreas, according to the protocol with curative intent.
Patients who can read and understand the Danish language.
Disqualifiers
None
Trial population
Patients who have undergone surgery in the pancreas, hepar or esophagus/cardia at Copenhagen University Hospital, Rigshospitalet
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
cancer surgery
Procedure/SurgeryAll surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Surgery, liver1 intervention
Group B: Surgery, esophagus or stomach1 intervention
Group C: Surgery, pancreas1 intervention
Trial outcomes
Primary outcomes
1
Median use of analgesics and opioids from the day of surgery until day seven after surgery
All analgesics provided from the day of surgery until seven days after surgery, calculated in median/means for the different surgical groups
Time frame
7 daysSecondary outcomes
1
Patients' preoperative expectations
Patients' preoperative expectations evaluated by the treatment expectation questionnaire (TEX-Q. The questionnaire contains 15 questions where the patient can rate their expectations from 0 to ten. 0 is no relief, no benefit or no improvement, and ten represents the opposite. Maximum score is 130 indicating very high expectations.
Time frame
At inclusion2
Daily pain measured by the patients
Patients will be asked to measure pain during rest and mobilisation, and the location of the pain. Pain will be rated by the Numeric Rating Scale from 0 to ten. 0 is no pain and ten is the worst imaginable pain
Time frame
From the day of surgery until the seventh day after surgery3
Fulfillment of patients´ expecations
Explore in which terms the patients´ expectations were fulfilled by interviewing the patients. We will use a semi-structured interview guide for this purpose.
Time frame
30 days after admission4
The development of chronic pain
We will interview the patients by phone and ask them to rate their pain and if they are still using analgesics. The pain will be rated by the Numeric Rating Scale from 0 to ten. 0 is no pain and ten is the worst imaginable pain. The analgesics will be mapped according to name and frequency used
Time frame
Six months after admissionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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