Expectation, Pain Outcomes, and Pain Medication Following Oncology Abdominal Surgery: A Cohort Study

Not yet recruiting

• Conditions: Cancer, Hepatic; Cancer, Esophagus; Cancer, Pancreas

• Registration Number: NCT07176052
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.

In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median use of analgesics and opioids from the day of surgery until day seven after surgery	7 days	All analgesics provided from the day of surgery until seven days after surgery, calculated in median/means for the different surgical groups

Secondary Outcome Measures

Name	Time	Method
Patients' preoperative expectations	At inclusion	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.
Daily pain measured by the patients	From the day of surgery until the seventh day after surgery	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
Fulfillment of patients´ expecations	30 days after admission	Explore in which terms the patients´ expectations were fulfilled by interviewing the patients. We will use a semi-structured interview guide for this purpose.
The development of chronic pain	Six months after admission	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
Postoperative quality of recovery	The day of surgery until the seventh day after surgery	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.
Health-related quality of life	Preoperatively and 30 days and six months after discharge	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
Level of Pain Catastrophizing	preoperatively	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.
Patient's perceived quality of recovery	The day of surgery until day seven after surgery	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).