Expectation, Pain Outcomes, and Pain Medication Following Oncology Abdominal Surgery: A Cohort Study
NCT ID: NCT07176052
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2025-10-01
2027-08-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgery, liver
Located in the liver
cancer surgery
All surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark
Surgery, esophagus or stomach
Located in the esophagus or stomach
cancer surgery
All surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark
Surgery, pancreas
Located in the pancreas
cancer surgery
All surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark
Interventions
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cancer surgery
All surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark
Eligibility Criteria
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Inclusion Criteria
* Patients who can read and understand the Danish language.
Exclusion Criteria
In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Anja Edith Geisler
Head of Research Nursing
Principal Investigators
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Anja Geisler, phd
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Flam J. PERIOPERATIVE TREATMENT OF GASTRIC CANCER - SHORT REVIEW. 2021; 49: 103-7
Arnold M, Ferlay J, van Berge Henegouwen MI, Soerjomataram I. Global burden of oesophageal and gastric cancer by histology and subsite in 2018. Gut. 2020 Sep;69(9):1564-1571. doi: 10.1136/gutjnl-2020-321600. Epub 2020 Jun 30.
Other Identifiers
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AEG-abdominalpain-2025
Identifier Type: -
Identifier Source: org_study_id
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