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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Median use of analgesics and opioids from the day of surgery until day seven after surgery [Срок оценки: 7 days]

Вторичные конечные точки (8)

• Patients' preoperative expectations [Срок оценки: At inclusion]
• Daily pain measured by the patients [Срок оценки: From the day of surgery until the seventh day after surgery]
• Fulfillment of patients´ expecations [Срок оценки: 30 days after admission]
• The development of chronic pain [Срок оценки: Six months after admission]
• Postoperative quality of recovery [Срок оценки: The day of surgery until the seventh day after surgery]
• Health-related quality of life [Срок оценки: Preoperatively and 30 days and six months after discharge]
• Level of Pain Catastrophizing [Срок оценки: preoperatively]
• Patient's perceived quality of recovery [Срок оценки: The day of surgery until day seven after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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,
• 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. PMID 28859388

Идентификаторы

NCT: NCT07176052 · AEG-abdominalpain-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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