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Comparison of Post-operative Pain and Quality of Life Between Subxiphoid and Intercostal VATS for Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331588
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ".


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months ]
    SF-MPQ-2 questionnaire is used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for surgery for lunge cancer.

Elective surgery (surgery planed > 2 days).

Accepts randomization.

Age 18 or above.

Exclusion Criteria:

  • Previous thoracic surgery.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331588


Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Publications:
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Responsible Party: Lei Jiang, associate chief physician, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03331588    
Other Study ID Numbers: leijiang
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China:
Lung cancer
Pain
Quality of life
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Thoracic Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Pain, Postoperative
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bronchial Neoplasms