Silastic Versus Conventional Drain in Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. The investigators designed a prospective randomized trial to compare the draining properties of the two types of drains following various resections in thoracic surgery.

Detailed Description
-----------------
Following the Institutional Review Board permission (permission no: 2009/27) the investigators started to recruit patients for the study in June 2009. Pneumonectomy, decortication, and diaphragm plication patients were not included in this study. The patients were consecutively placed in one of the two groups. In Group I, an apical 28FR size CD, and a basal 19FR SD were placed following surgery. In Group II, the apical drain was 28FR, and the basal drain was 32FR CDs. Basal drains were removed out when daily serous fluid drainage became 200 ml or less, and the apical were removed 48-72 hours following the cessation of air leak. The patients were discharged on the day after drain removal. The data concerning gender, age, diagnosis, operation side, type of operation, amount of fluid drainage, duration of fluid and air drainage, length of hospital stay, and complications if any, were noted.

Official Title
-----------------
Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.

Conditions
-----------------
Air Leak From Lung, Post Procedural Persistent Drain Fluid

Intervention / Treatment
-----------------
* Procedure: Silastic vs conventional drain in thoracic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form. Exclusion Criteria: Pneumonectomy, diaphragm plication, and decortication candidates

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silastic drain<br>Placement of 19FR silastic drain as basal drain | Procedure: Silastic vs conventional drain in thoracic surgery<br>* Apical drains will be identical in size and material, and the basal drains will be different in groups. The patients will be followed for daily amounts of fluid drainage, duration of air leaks and fluid drainage, and duration of hospitalization, and the results will be compared statistically to asses any possible relationships with the outcome and the type of basal drain used.<br>|
| Active Comparator: Conventional drain<br>Placement of 32FR conventional drain as basal drain | Procedure: Silastic vs conventional drain in thoracic surgery<br>* Apical drains will be identical in size and material, and the basal drains will be different in groups. The patients will be followed for daily amounts of fluid drainage, duration of air leaks and fluid drainage, and duration of hospitalization, and the results will be compared statistically to asses any possible relationships with the outcome and the type of basal drain used.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | Duration of hospital stay will be noted on the study datasheet and will be measured in days. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily amount of fluid drainage | Daily amount of fluid drainage will be measured in mililiters during the daily rounds everyday, and will be noted on the datasheet. | 3 years | 
| Duration of fluid drainage | Everyday the drains will be checked for fluid drainage and the day without any drainage will be noted on the datasheet. Duration of fluid drainage will be measured in days since the postoperative day 1. | 3 years | 
| Duration of air leak | Everyday the drains will be checked for air leaks and the day without any air leak will be noted on the datasheet. Duration of air leak will be measured in days since the postoperative day 1. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silastic drains, thoracic surgery, conventional drains