Silastic Versus Conventional Drain in Thoracic Surgery

Not Applicable

Completed

• Conditions: Air Leak From Lung; Post Procedural Persistent Drain Fluid
• Interventions: Procedure: Silastic vs conventional drain in thoracic surgery

• Registration Number: NCT03056716
• Lead Sponsor: T.C. Dumlupınar Üniversitesi

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-16
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silastic drain	Silastic vs conventional drain in thoracic surgery	Placement of 19FR silastic drain as basal drain
Conventional drain	Silastic vs conventional drain in thoracic surgery	Placement of 32FR conventional drain as basal drain

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	3 years	Duration of hospital stay will be noted on the study datasheet and will be measured in days.

Secondary Outcome Measures

Name	Time	Method
Daily amount of fluid drainage	3 years	Daily amount of fluid drainage will be measured in mililiters during the daily rounds everyday, and will be noted on the datasheet.
Duration of fluid drainage	3 years	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.
Duration of air leak	3 years	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.

Trial Locations

Locations (1)

Bursa Yuksek Ihtisas Research and Education Hospital; 🇹🇷 Bursa, Yildirim, Turkey