Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Duration of hospital stay
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Duration of hospital stay
Time Frame: 3 years
Duration of hospital stay will be noted on the study datasheet and will be measured in days.
Secondary Outcomes
- Daily amount of fluid drainage(3 years)
- Duration of fluid drainage(3 years)
- Duration of air leak(3 years)
Investigators
Serhat Yalcinkaya,MD
Assist. Prof. of Thoracic Surgery
T.C. Dumlupınar Üniversitesi