## Protocol Section
### Identification Module
**NCT ID:** NCT06425601

**Brief Title:** A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy

**Official Title:** The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains

#### Organization Study ID Info
**ID:** 0120-445/2019/8
#### Organization
**Class:** OTHER
**Full Name:** University Medical Centre Ljubljana
### Status Module
#### Completion Date
**Date:** 2023-08-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-08-10

**Type:** ACTUAL

#### Start Date
**Date:** 2020-09-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Medical Centre Ljubljana

#### Responsible Party

**Investigator Affiliation:** University Medical Centre Ljubljana

**Investigator Full Name:** Boris Greif, MD

**Investigator Title:** Head of Thoracic Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Postoperative Pain

- Postoperative Complications

**Keywords:**

- VATS

- lung lobectomy

- postoperative pain

- chest drain

- analgesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Device: SIL drain

**Label:** Silicone (SIL) group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Device: PVC drain

**Label:** PVC group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Silicone (SIL) group

**Description:** Silicone chest tube used for pleural space drainage after VATS lobectomy

**Name:** SIL drain

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- PVC group

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

**Name:** PVC drain

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.

**Measure:** Analgesics consumption

**Time Frame:** 2 days

**Description:** Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.

**Measure:** Need for peroral analgesia after the chest tube removal

**Time Frame:** 2 days

**Description:** Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.

**Measure:** Maximal inspiratory pressure

**Time Frame:** 2 days

**Description:** Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.

**Measure:** Maximal expiratory pressure

**Time Frame:** 2 days

**Description:** Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.

**Measure:** Visual analogue scale

**Time Frame:** 2 days

#### Secondary Outcomes

**Description:** The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome.

**Measure:** Duration of chest drainage

**Time Frame:** 1 month

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.

**Measure:** Pneumothorax rate on the day of surgery

**Time Frame:** First day

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.

**Measure:** Pneumothorax rate after chest tube removal

**Time Frame:** 1 month

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.

**Measure:** Pleural effusion rate on the day of surgery

**Time Frame:** First day

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.

**Measure:** Pleural effusion rate after chest tube removal

**Time Frame:** 1 month

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome.

**Measure:** Subcutaneous emphysema rate

**Time Frame:** 1 month

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome.

**Measure:** Prolonged air leak rate

**Time Frame:** 1 month

**Description:** The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome.

**Measure:** Reintervention rate

**Time Frame:** 1 month

**Description:** Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome.

**Measure:** Duration of hospital stay

**Time Frame:** 1 month

**Description:** Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome.

**Measure:** Respiratory complication rate

**Time Frame:** 1 month

**Description:** Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome.

**Measure:** Readmission rate

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ljubljana

**Country:** Slovenia

**Facility:** University Medical Centre Ljubljana

**Zip:** 1000

#### Overall Officials

**Official 1:**

**Affiliation:** UMC Ljubljana

**Name:** Boris Greif

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: HIGH

- As Found: Postoperative Complications

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

- ID: D000011183

- Term: Postoperative Complications

### Misc Info Module

- Version Holder: 2024-05-31
