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NCT Number: NCT03331588

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

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.

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Key information

Conditions

Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasm Thoracic Neoplasms Thoracic Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Intercostal uniportal VATS

Procedure

The surgical procedures followed principles of pulmonary resections

Primary outcomes

  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 outcomes

  1. Quality of life

    Time frame: 6 months

    SF-MPQ-2 questionnaire is used.

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Comparison Study of Post-operative Pain and Quality of Life Between Subxiphoid and Intercostal Vedio-assisted Thoracic Surgery for Radical Lung Cancer Resection

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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