Expectation, Pain Outcomes, and Analgesic Efficacy Following Oncology Abdominal Surgery: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Median use of analgesics and opioids from the day of surgery until day seven after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Median use of analgesics and opioids from the day of surgery until day seven after surgery
时间窗: 7 days
All analgesics provided from the day of surgery until seven days after surgery, calculated in median/means for the different surgical groups
次要结局
- 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)
- Health-related quality of life(Preoperatively and 30 days and six months after discharge)
- Level of Pain Catastrophizing(preoperatively)
- Patient's perceived quality of recovery(The day of surgery until day seven after surgery)
研究者
Anja Edith Geisler
Head of Research Nursing
Rigshospitalet, Denmark