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

Phase 3

Completed

• Conditions: Thoracic Surgery; Carcinoma, Bronchogenic; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Thoracic Neoplasm
• Interventions: Procedure: Subxiphoid uniportal VATS; Procedure: Intercostal uniportal VATS

• Registration Number: NCT03331588
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-06
• Study Start: 2017-11-10
• Status Verified: 2020-02
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subxiphoid uniportal VATS	Subxiphoid uniportal VATS	Standard Subxiphoid single-port video assisted thoracic surgery, no use of rib-spreader.
Intercostal uniportal VATS	Intercostal uniportal VATS	Standard Intercostal single-port video assisted thoracic surgery, no use of rib-spreader.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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

Name	Time	Method
Quality of life	6 months	SF-MPQ-2 questionnaire is used.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China