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2025-10-01
2026-10-01
2027-08-01
200
NCT07176052
Rigshospitalet, Denmark
Rigshospitalet, Denmark
OBSERVATIONAL
Expectation, Pain Outcomes, and Pain Medication Following Oncology Abdominal Surgery: A Cohort Study
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.
This study includes one main study and two sub-studies. The main study and sub-study 1a are both prospective observational cohort studies. Study 1b is a qualitative study that includes semi-structured interviews with the included patients. No formal sample size calculation was performed, as the study method is exploratory. Location of the study This study will be conducted at the Department of Transplantation and Organ Surgery at Copenhagen University Hospital, Rigshospitalet, Denmark, from October 1, 2025, to October 1, 2026. Study 1b will be performed by phone. Participants The participants will include patients undergoing major hepatic surgery, surgery in the esophagus or cardia, or major surgery on the pancreas performed at Rigshospitalet. Inclusion criteria Patients must meet the following criteria to be suitable for inclusion in the study. Patients > 18 years undergoing elective primary surgical treatment according to the protocol with curative intent. Patients who can read and understand the Danish language. Exclusion criteria Patients meeting one or more of the following criteria are ineligible for inclusion in this study. Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator. Procedure for patients who withdraw from the trial In accordance with the Declaration of Helsinki 24, patients have the right to withdraw from the study at any time for any reason, but the reason must be recorded in the patient's Case Report Form if the cause is known.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-08-25 | N/A | 2025-09-09 |
2025-09-09 | N/A | 2025-09-16 |
2025-09-16 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Surgery, liver Located in the liver | PROCEDURE: cancer surgery
|
| : Surgery, esophagus or stomach Located in the esophagus or stomach | PROCEDURE: cancer surgery
|
| : Surgery, pancreas Located in the pancreas | PROCEDURE: cancer surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | At inclusion |
| 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 | From the day of surgery until the seventh day after surgery |
| 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. | 30 days after admission |
| 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 | Six months after admission |
| Postoperative quality of recovery | The patients will be asked to fill out the QoR-15D questionnaire to rate their postoperative quality of recovery. The questionnaire contains 15 questions with a part A which rates every question from 0 indicating at no point to 10 all the time. Part B is the opposite. A high score indicates a good recovery and the score ranges from 0 to 150. | The day of surgery until the seventh day after surgery |
| Health-related quality of life | The patients will be asked to fill out the questionnaire EQ-5D-5L to measure health-related quality of life. The questionnaire contains five areas; ability to move, personal care, activities, pain and anxiety/depression. Every arera can be rated in five different ways differing from no problems to it is not possible to perform activities, extreme pain or anxiety. Finally the questionnaire includes a scale from 0 indicating the worst health you can imagine to 100 indicating the very best. The patient should place an X on the number indicating the self-evaluated health | Preoperatively and 30 days and six months after discharge |
| Level of Pain Catastrophizing | The PCS (Pain Catastrophizing Scale) will be used for this purpose. The PCS is a 13-item self-report questionnaire designed to measure catastrophic thinking related to pain. Each item is rated on a 5-point scale: 0: Not at all, 1: To a slight degree, 2: To a moderate degree, 3: To a great degree, 4: All the time. The total PCS score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. Scores ≥30 are considered to reflect a clinically relevant level of catastrophizing and correspond to the 75th percentile in chronic pain clinic populations. Scores between the 50th and 75th percentile (typically 20-29) indicate moderate risk, while scores above 30 suggest high risk for persistent pain and disability. | preoperatively |
| Patient's perceived quality of recovery | The patient's perceived quality of recovery will be monitored using the QoR-15D. The score ranges from 0 to 15025,26. An excellent quality will be considered for numbers from 136-150. Good quality for 122-135. Moderate quality: 90-121; poor quality: 0-89. Health-related quality of life will be collected preoperatively and at 30 days (+/-7 days) postoperatively using the EQ-5D-5L. The EQ-5D-5L uses five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels: 1. No problems. 2. Slight problems. 3. Moderate problems. 4. Severe problems. 5. Extreme problems (or unable to do). | The day of surgery until day seven after surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Anja Geisler, phD Phone Number: +4523318446 Email: anja.edith.geisler@regionh.dk |
Study Contact Backup Name: Eva Jørgensen, RN Phone Number: Email: eva.maria.bjerg.joergensen@regionh.dk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
