Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries

January 27, 2022 updated by: Al-Quds University
Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post lung resection patients (via Uniportal VATS only)
  • Over the age of 18
  • indicated chest tube

Exclusion Criteria:

  • Under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clamping
This arm will undergo chest drain clamping after a certain criteria has been met. Four hours post clamping a chest x-ray will be made, and the presence of pneumothorax will be assessed. The chest drain will be removed only in the absence of pneumothorax, if pneumothorax persists patients will stay attached to the underwater seal
Other: Clamping
Clamping of chest tube
Active Comparator: Urine bag
The second arm will be attached to a urine bag, and bag inflation will be measured after a certain criteria has been met. bag inflation will be assessed four hours after its attachment. Bag inflation indicates the persistence of an air leak, thus the absence of bag inflation indicates the removal of the chest drain
Other: Urine bag
Attachment of a urine bag to chest tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cost
Time Frame: 5 to 6 days
The overall cost of the patient's hospital stay
5 to 6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag
Time Frame: up to 5 days
An important side effect to be studied
up to 5 days
total number of days with chest drain inserted
Time Frame: up to 5 days
Number of days chest drain remained inserted
up to 5 days
Number of chest x-rays
Time Frame: up to 5 days
Total number of chest x-rays
up to 5 days
Number of participants that faced other intervention associated side effects
Time Frame: up to 5 days
Subcutaneous emphysema, tension pneumothorax and others
up to 5 days
Number of participants with chest tube re-insertion
Time Frame: up to 5 days
An important side effect
up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Quds University

Collaborators

Assiut University
Tanta University
European Institute of Oncology

Investigators

  • Principal Investigator: Firas Abuakar, MD, Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine
  • Study Chair: Osama Darras, MD candidate, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
  • Study Chair: Hadeel Abedalhameed, MD candidate, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
  • Study Director: Rami Alaraj, MD candidate, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
  • Study Chair: Rania Attiyeh, MD candidate, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

November 25, 2022

Study Completion (Anticipated)

December 25, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/REC-CT/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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