Comparison of Post-operative Pain and Quality of Life Between Subxiphoid and Intercostal VATS for Lung Cancer
|ClinicalTrials.gov Identifier: NCT03331588|
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Thoracic Surgery Carcinoma, Non-Small-Cell Lung Lung Diseases Carcinoma, Bronchogenic Thoracic Neoplasm||Procedure: Subxiphoid uniportal VATS Procedure: Intercostal uniportal VATS||Phase 3|
Is subxiphoid route VATS surgery better than Intercostal VATS surgery for lung cancer?
Video assisted thoracoscopic surgery for lung cancer (VATS) is less traumatic than traditional open surgery for lung cancer. A novel uniportal VATS technique involving a subxiphoid route for thoracic surgery has been occured. It is reported that subxiphoid route VATS surgery is better than Intercostal VATS surgery in post-operative pain and quality of life, but this has never been documented in a randomized trial. Some surgeons hesitate to use subxiphoid VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world, while Shanghai pulmonary Hospital is one of the best to perform subxiphoid VATS. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year.
The investigators include patients with stage I lung cancer, and randomize between subxiphoid VATS and Intercostal VATS in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 1 time daily and followed 6 months using the VAS-score, life quality is evaluated continuously during the first 6 months using SF-MPQ-2 questionnaires.
200 patients will be asked to participate in each study at shanghai pulmonary Hospital,china in collaboration with surgeons from department of thoracic surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||In the operating room a dressing will be placed so that it covers the entire hemithorax whereby the incision is hidden. This is done identically regardless of surgical technique. This dressing is left in place until discharge. If changing of the dressing is needed, either the project-nurse or a nurse for another team will assist.|
|Official Title:||Comparison Study of Post-operative Pain and Quality of Life Between Subxiphoid and Intercostal Vedio-assisted Thoracic Surgery for Radical Lung Cancer Resection|
|Actual Study Start Date :||November 10, 2017|
|Actual Primary Completion Date :||February 28, 2020|
|Actual Study Completion Date :||February 28, 2020|
Active Comparator: Subxiphoid uniportal VATS
Standard Subxiphoid single-port video assisted thoracic surgery, no use of rib-spreader.
Procedure: Subxiphoid uniportal VATS
Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections
Active Comparator: Intercostal uniportal VATS
Standard Intercostal single-port video assisted thoracic surgery, no use of rib-spreader.
Procedure: Intercostal uniportal VATS
The surgical procedures followed principles of pulmonary resections
- Postoperative pain [ Time Frame: 6 months ]visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
- Quality of life [ Time Frame: 6 months ]SF-MPQ-2 questionnaire is used.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331588
|Shanghai Pulmonary Hospital|
|Shanghai, Shanghai, China, 200433|