Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subxiphoid uniportal VATS | Active Comparator | Standard Subxiphoid single-port video assisted thoracic surgery, no use of rib-spreader. |
|
| Intercostal uniportal VATS | Active Comparator | Standard Intercostal single-port video assisted thoracic surgery, no use of rib-spreader. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subxiphoid uniportal VATS | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | 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 ". | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | SF-MPQ-2 questionnaire is used. | 6 months |
Not provided
Inclusion Criteria:
Elective surgery (surgery planed > 2 days).
Accepts randomization.
Age 18 or above.
Exclusion Criteria:
Any type of chronic pain, requiring daily use of analgetics.
pregnant.
Breast feeding.
contraindications to NSAID.
Chemo- and/or radiotherapy in connection to present admission.
Major surgery planned in connection to this admission.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27076952 | Background | Gonzalez-Rivas D, Yang Y, Lei J, Hernandez L, Jiang G. Subxiphoid uniportal video-assisted thoracoscopic middle lobectomy and anterior anatomic segmentectomy (S3). J Thorac Dis. 2016 Mar;8(3):540-3. doi: 10.21037/jtd.2016.02.63. | |
| 27401700 | Background | Hernandez-Arenas LA, Lin L, Yang Y, Liu M, Guido W, Gonzalez-Rivas D, Jiang G, Jiang L. Initial experience in uniportal subxiphoid video-assisted thoracoscopic surgery for major lung resections. Eur J Cardiothorac Surg. 2016 Dec;50(6):1060-1066. doi: 10.1093/ejcts/ezw189. Epub 2016 Jul 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Parallel Assignment
Not provided
Not provided
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.
| Intercostal uniportal VATS | Procedure | The surgical procedures followed principles of pulmonary resections |
|
| 27014471 | Background | Song N, Zhao DP, Jiang L, Bao Y, Jiang GN, Zhu YM, Ding JA. Subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for lobectomy: a report of 105 cases. J Thorac Dis. 2016 Mar;8(Suppl 3):S251-7. doi: 10.3978/j.issn.2072-1439.2016.02.32. |
| 35579360 | Derived | Chen Z, Jiang L, Zheng H, Zhang W, Lv X, Abdellateef A. Early postoperative pain after subxiphoid uniportal thoracoscopic major lung resection: a prospective, single- blinded, randomized controlled trial. Interact Cardiovasc Thorac Surg. 2022 Jun 15;35(1):ivac133. doi: 10.1093/icvts/ivac133. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008171 | Lung Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D013899 | Thoracic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D001984 | Bronchial Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided