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

NCT03331588 | Completed Phase 3 DMC

• 1 other identifier: leijiang
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Thoracic Surgery; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Carcinoma, Bronchogenic; Thoracic Neoplasm

Keywords

Lung cancer; Pain; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of life

  6 months

Study Arms (2)

Subxiphoid uniportal VATS

ACTIVE COMPARATOR

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

Procedure: Subxiphoid uniportal VATS

Intercostal uniportal VATS

ACTIVE COMPARATOR

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

Procedure: Intercostal uniportal VATS

Interventions

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

Subxiphoid uniportal VATS

Intercostal uniportal VATS PROCEDURE

The surgical procedures followed principles of pulmonary resections

Intercostal uniportal VATS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for surgery for lunge cancer.
• Elective surgery (surgery planed \> 2 days).
• Accepts randomization.
• Age 18 or above.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (4)

• 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.

  PMID: 27076952 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.

  PMID: 27401700 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.

  PMID: 27014471 BACKGROUND

• 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.

  PMID: 35579360 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Carcinoma, Bronchogenic; Thoracic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Bronchial Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: November 10, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)