Comparison of Post-operative Pain and Quality of Life Between Subxiphoid and Intercostal VATS for Lung Cancer
Condition: Lung Neoplasms; Thoracic Surgery; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Carcinoma, Bronchogenic; Thoracic Neoplasm
MeSH terms: Carcinoma; Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Thoracic Neoplasms; Carcinoma, Bronchogenic; Lung Diseases; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      One-thirds of patients underwent video-assisted thorascopic surgery (VATS) still have severe
      pain.Uniportal lobectomy or segmentectomies emerged as a promising and exciting approach for
      minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies
      have been performed via the intercostal route, and chest wall trauma has still occurred.
      Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route
      for pulmonary lobectomies or segmentectomies.We would like to evaluate the post-operative
      pain and quality of life between Subxiphoid and Intercostal VATS for Lung Cancer.
    

Detailed description: 
      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.
    

Intervention name(s): Subxiphoid uniportal VATS; Intercostal uniportal VATS
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; The surgical procedures followed principles of pulmonary resections
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Lung cancer; Pain; Quality of life