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

NCT07176052 | Not Yet Recruiting DMC

• 1 other identifier: AEG-abdominalpain-2025
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer, Hepatic; Cancer, Esophagus; Cancer, Pancreas

Keywords

Acute pain; patient expectations; Cancer in the upper abdominal; analgesics; patients self-rating

Outcome Measures

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

  7 days

Secondary Outcomes (8)

• Patients' preoperative expectations

  At inclusion

• Daily pain measured by the patients

  From the day of surgery until the seventh day after surgery

• Fulfillment of patients´ expecations

  30 days after admission

• The development of chronic pain

  Six months after admission

• Postoperative quality of recovery

  The day of surgery until the seventh day after surgery

Study Arms (3)

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

Interventions

cancer surgery PROCEDURE

All surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark

Surgery, esophagus or stomach; Surgery, liver; Surgery, pancreas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone surgery in the pancreas, hepar or esophagus/cardia at Copenhagen University Hospital, Rigshospitalet

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Publications (17)

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  BACKGROUND

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MeSH Terms

Conditions

Liver Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms; Acute Pain

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anja Geisler, phd

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Geisler, phD

CONTACT

+4523318446; anja.edith.geisler@regionh.dk

Eva Jørgensen, RN

CONTACT

eva.maria.bjerg.joergensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Nursing

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share