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Cancer, HepaticNCT07176052

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

An observational study of Cancer, Hepatic and Cancer, Esophagus, run by Copenhagen University Hospital, Rigshospitalet.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cancer surgery
Type of treatment
Surgery or procedure
How many people
200 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Aug 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Expectation, Pain Outcomes, and Analgesic Efficacy 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.

  1. 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.
Read the 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.

Being tested
cancer surgery
Keywords
Acute pain, patient expectations, Cancer in the upper abdominal, analgesics, patients self-rating
Medical subject headings
Liver Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cancer surgeryProcedure or surgery

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

Study groups in NCT07176052
Study groupRoleWhat they receive
Surgery, liverLocated in the liver
Receives: Procedure: cancer surgery
Surgery, esophagus or stomachLocated in the esophagus or stomach
Receives: Procedure: cancer surgery
Surgery, pancreasLocated in the pancreas
Receives: Procedure: cancer surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days

Secondary outcomes (8)
  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.

    Measured: At inclusion

  2. 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

    Measured: From the day of surgery until the seventh day after surgery

  3. 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.

    Measured: 30 days after admission

  4. 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

    Measured: Six months after admission

  5. 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.

    Measured: The day of surgery until the seventh day after surgery

  6. 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

    Measured: Preoperatively and 30 days and six months after discharge

  7. 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.

    Measured: preoperatively

  8. 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).

    Measured: The day of surgery until day seven after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176052
Sponsor's protocol ID
AEG-abdominalpain-2025
Status last verified
Sep 2025
First submitted
25 Aug 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I do not need to share the IPD with other researchers

Publications

  • Hanley C, Ladha KS, Clarke HA, Cuthbertson BC, Wijeysundera DN; METS Study Investigators. Association of postoperative complications with persistent post-surgical pain: a multicentre prospective cohort study. Br J Anaesth. 2022 Feb;128(2):311-320. doi: 10.1016/j.bja.2021.10.027. Epub 2021 Dec 3.

    PubMed 34872718
  • Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

    PubMed 29397134
  • Kleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand. 2015 Aug;59(7):912-20. doi: 10.1111/aas.12525. Epub 2015 Apr 13.

    PubMed 25867135
  • Fantola G, Brunaud L, Nguyen-Thi PL, Germain A, Ayav A, Bresler L. Risk factors for postoperative complications in robotic general surgery. Updates Surg. 2017 Mar;69(1):45-54. doi: 10.1007/s13304-016-0398-4. Epub 2016 Sep 30.

    PubMed 27696276
  • Angelica MD, Fong Y. Patient Expectations and Patient-Reported Outcomes. October 2008; 141: 520-9.

  • Hawker GA, Conner-Spady BL, Bohm E, Dunbar MJ, Jones CA, Ravi B, Noseworthy T, Dick D, Powell J, Paul P, Marshall DA; BEST-Knee Study Team. Patients' Preoperative Expectations of Total Knee Arthroplasty and Satisfaction With Outcomes at One Year: A Prospective Cohort Study. Arthritis Rheumatol. 2021 Feb;73(2):223-231. doi: 10.1002/art.41510. Epub 2020 Dec 26.

    PubMed 32892511
  • Filbay SR, Judge A, Delmestri A, Arden NK, Altman D, Beard D, Carr A, Cooper C, Culliford D, Griffin T, Javaid K, Latham J, Murray D, Pinedo-Villanueva R, Price A, Prieto-Alhambra D, Frisaldi E, Shaibani A, Benedetti F, Waljee J, Mcglinn EP, Sears ED, Chung KC, Roine R, Ohinmaa A, Hailey D, Rief W, Shedden-mora MC, Laferton JAC, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R, Younger J, Gandhi V, Hubbard E, Mackey S, Arrow K, Burgoyne LL, Rainville P, Jumma W, Mohamed M, Joseph L, Canby G, Paungmali A, Sitilertpisan P, Pirunsan U, Verbeek J. Evaluating Patients' Expectations From a Novel Patient-Centered Perspective Predicts Knee Arthroplasty Outcome. Pain Ther 2017; 6: 2146-2152.e4.

  • Visser E, Marsman M, van Rossum PSN, Cheong E, Al-Naimi K, van Klei WA, Ruurda JP, van Hillegersberg R. Postoperative pain management after esophagectomy: a systematic review and meta-analysis. Dis Esophagus. 2017 Oct 1;30(10):1-11. doi: 10.1093/dote/dox052.

    PubMed 28859388
  • Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.

    PubMed 35803751
  • Desai N, El-Boghdadly K, Albrecht E. Epidural vs. transversus abdominis plane block for abdominal surgery - a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2021 Jan;76(1):101-117. doi: 10.1111/anae.15068. Epub 2020 May 8.

    PubMed 32385856
  • Hemmerling TM. Pain management in abdominal surgery. Langenbecks Arch Surg. 2018 Nov;403(7):791-803. doi: 10.1007/s00423-018-1705-y. Epub 2018 Oct 3.

    PubMed 30284029
  • Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

    PubMed 24237004
  • Arnold M, Abnet CC, Neale RE, Vignat J, Giovannucci EL, McGlynn KA, Bray F. Global Burden of 5 Major Types of Gastrointestinal Cancer. Gastroenterology. 2020 Jul;159(1):335-349.e15. doi: 10.1053/j.gastro.2020.02.068. Epub 2020 Apr 2.

    PubMed 32247694
  • Deo SVS, Sharma J, Kumar S. GLOBOCAN 2020 Report on Global Cancer Burden: Challenges and Opportunities for Surgical Oncologists. Ann Surg Oncol. 2022 Oct;29(11):6497-6500. doi: 10.1245/s10434-022-12151-6. Epub 2022 Jul 15.

    PubMed 35838905
  • Sullivan R, Alatise OI, Anderson BO, Audisio R, Autier P, Aggarwal A, Balch C, Brennan MF, Dare A, D'Cruz A, Eggermont AM, Fleming K, Gueye SM, Hagander L, Herrera CA, Holmer H, Ilbawi AM, Jarnheimer A, Ji JF, Kingham TP, Liberman J, Leather AJ, Meara JG, Mukhopadhyay S, Murthy SS, Omar S, Parham GP, Pramesh CS, Riviello R, Rodin D, Santini L, Shrikhande SV, Shrime M, Thomas R, Tsunoda AT, van de Velde C, Veronesi U, Vijaykumar DK, Watters D, Wang S, Wu YL, Zeiton M, Purushotham A. Global cancer surgery: delivering safe, affordable, and timely cancer surgery. Lancet Oncol. 2015 Sep;16(11):1193-224. doi: 10.1016/S1470-2045(15)00223-5.

    PubMed 26427363

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, Hepatic and Cancer, Esophagus, run by Copenhagen University Hospital, Rigshospitalet.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anja Geisler, phD (+4523318446, anja.edith.geisler@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median use of analgesics and opioids from the day of surgery until day seven after surgery (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176052, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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