A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2023-08-10

Brief Summary

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The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.

The main questions it aims to answer are:

* silicone chest drains are less painful compared to standard PVC drains?
* is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.

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Detailed Description

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Conditions

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Postoperative Pain Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Silicone (SIL) group

For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used

Group Type EXPERIMENTAL

SIL drain

Intervention Type DEVICE

Silicone chest tube used for pleural space drainage after VATS lobectomy

PVC group

For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used

Group Type ACTIVE_COMPARATOR

PVC drain

Intervention Type DEVICE

Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy

Interventions

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SIL drain

Silicone chest tube used for pleural space drainage after VATS lobectomy

Intervention Type DEVICE

PVC drain

Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* primary lung cancer eligible for VATS lobectomy by tumor board meeting

Exclusion Criteria

* age under 18 years
* high risk of post-operative complications (ASA \> 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) \< 15 ml/kg/min)
* tumors growing in parietal pleura
* extended lung resection diffuse
* previous surgery in the same hemithorax
* chronic pain
* chronic use of analgesics or sedatives
* surgical revision
* inability to participate in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No