Clinical trial NCT05473728: Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery
Official title: A Nationwide Multi-center Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Video-assisted thoracic surgery
Chronic post-surgical pain
Epidemiology study
risk factors
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Tianjin Medical University Cancer Institute and Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Xiangya Hospital of Central South University
name: Shanghai Chest Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The people's hospital of Xinjiang
name: Cancer hospital affiliated to Xinjiang Medical Universtity
name: Gansu provincial hospital of TCM
name: Tibet Autonomous Region People's Hospital
First posted: 2022-07-26
Enrollment: 886
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our research focuses on the incidence of CPSP after VATS in Chinese population. So, our target population will be all the Chinese patients receiving VATS in China. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month.

Therefore, the accessible population in our study is all the patients receiving VATS in Aug., 2022 at selected medical centers in all seven geographical subregions of China.

Brief summary: This study is a nationwide multi-center study to investigate the incidence and risk factors of chronic post-surgical pain (CPSP) after receiving video-assisted thoracic surgery (VATS). Patients receiving VATS in participating centers across China in Aug. 2022 will be assessed for eligibility, and all the enrolled patients will be followed up for at least 6 months. The study's primary outcome is the incidence of CPSP 6 months after VATS. Baseline demographic, psychological , surgical, anesthesia-related and pain-related characteristics will be evaluated for possible risk factors of CPSP after VATS.

Detailed description: Study Overview This is a multi-center perspective cohort study on the incidence and risk factors of CPSP after VATS.

Study aims

1. Investigate the incidence of chronic post-surgical pain in Chinese population who received video-assisted thoracic surgery by carrying out a multi-center, perspective cohort study
2. Perform regression analysis to evaluate the risk factors for chronic post-surgical pain in video-assisted thoracoscopic surgery.
3. Establish a risk-prediction model for CPSP after VATS

Time frame:

We plan to recruit patients from Aug 1st, 2022 to Sept 1st, 2022. And our follow-up will be performed at 1 month, 3 months and 6 months after the surgeries. After completing the follow-up of all patients, we are going to build a risk-prediction model and have it validated.

Study subjects Our research focuses on the incidence of CPSP after VATS in Chinese population. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month.

Plan for sampling As described before, our study plans to sample all the patients receiving VATS in participating medical centers across China for one month.

Plan for recruitment All patients receiving VATS in our participating centers will be examined for recruitment by the local coordinators according to our inclusion and exclusion criteria.

Plan for retaining subjects We are going to follow up the patients for at least 6 months after the surgery. At the pre-Op visit, the patient will be informed of the study time frame and he/she will be called by researcher in PUMCH during their follow-up. After their discharge, we will contact the patients and call them at 1, 3, 6 months after surgery.

Patient Registries We will use standard case report form (CRF) and electronic data capture (EDC) system for patient registries. All the data required in this study will be obtained by patient interview and medical records and recorded in our CRF and uploaded into EDC system. Researchers in participating centers will collect patient information by interview during their stay at the hospital. An SOP and interviewer training session will be developed for the study. The EDC system will help with data check, data dictionary. And our data monitoring board in PUMCH will check the uploaded data while follow-up telephoning the patients.

Statistical analysis plan Sample size Expected incidence: 30% Comment: the average reported incidence of CPSP after VATS Desired precision: 10% (total width) Confidence level: 95% Therefore, the estimated sample size with the above-mentioned parameters is 323 The risk factors will be analyzed by Logistics regression.

Eligibility criteria: Inclusion Criteria:

* In-patients at participating medical centers
* Scheduled for unilateral VATS during the study enrollment period

Exclusion Criteria:

* Emergency surgeries
* Patients with known pain sensory impairment
* Patients cannot express themselves so that an NRS score cannot be measured

Primary outcomes:
measure: post-surgical pain-6 month
timeFrame: 6 month after the VATS
Secondary outcomes:
measure: post-surgical pain-3 month
timeFrame: 3 month after the VATS
measure: Influence on quality of life
timeFrame: 3\6 month after the VATS
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Le Shen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: