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

Primary Purpose

Lung Neoplasms, Thoracic Surgery, Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Subxiphoid uniportal VATS
Intercostal uniportal VATS
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Lung cancer, Pain, Quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Subxiphoid uniportal VATS

Intercostal uniportal VATS

Arm Description

Standard Subxiphoid single-port video assisted thoracic surgery, no use of rib-spreader.

Standard Intercostal single-port video assisted thoracic surgery, no use of rib-spreader.

Outcomes

Primary Outcome Measures

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 ".

Secondary Outcome Measures

Quality of life
SF-MPQ-2 questionnaire is used.

Full Information

First Posted
November 1, 2017
Last Updated
February 28, 2020
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03331588
Brief Title
Comparison of Post-operative Pain and Quality of Life Between Subxiphoid and Intercostal VATS for Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Thoracic Surgery, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Carcinoma, Bronchogenic, Thoracic Neoplasm
Keywords
Lung cancer, Pain, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subxiphoid uniportal VATS
Arm Type
Active Comparator
Arm Description
Standard Subxiphoid single-port video assisted thoracic surgery, no use of rib-spreader.
Arm Title
Intercostal uniportal VATS
Arm Type
Active Comparator
Arm Description
Standard Intercostal single-port video assisted thoracic surgery, no use of rib-spreader.
Intervention Type
Procedure
Intervention Name(s)
Subxiphoid uniportal VATS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Intercostal uniportal VATS
Intervention Description
The surgical procedures followed principles of pulmonary resections
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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 ".
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
SF-MPQ-2 questionnaire is used.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27076952
Citation
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.
Results Reference
background
PubMed Identifier
27401700
Citation
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.
Results Reference
background
PubMed Identifier
27014471
Citation
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.
Results Reference
background
PubMed Identifier
35579360
Citation
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.
Results Reference
derived

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

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