Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries

NCT ID: NCT05230420

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-25

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumothorax and Air Leak Pneumothorax Pleura Injury Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Clamping

Intervention Type OTHER

Clamping of chest tube

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

Group Type ACTIVE_COMPARATOR

Urine bag

Intervention Type OTHER

Attachment of a urine bag to chest tube

Interventions

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Clamping

Clamping of chest tube

Intervention Type OTHER

Urine bag

Attachment of a urine bag to chest tube

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role collaborator

European Institute of Oncology

OTHER

Sponsor Role collaborator

Al-Quds University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Firas Abuakar, MD

Role: PRINCIPAL_INVESTIGATOR

Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine

Osama Darras, MD candidate

Role: STUDY_CHAIR

Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

Hadeel Abedalhameed, MD candidate

Role: STUDY_CHAIR

Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

Rami Alaraj, MD candidate

Role: STUDY_DIRECTOR

Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

Rania Attiyeh, MD candidate

Role: STUDY_CHAIR

Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

Locations

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Assiut University

Asyut, , Egypt

Site Status NOT_YET_RECRUITING

Tanta University

Tanta, , Egypt

Site Status NOT_YET_RECRUITING

European Institute of Oncology

Milan, , Italy

Site Status NOT_YET_RECRUITING

Makassed Hospital

East Jerusalem, , Palestinian Territories

Site Status RECRUITING

Countries

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Egypt Italy Palestinian Territories

Central Contacts

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Firas Abuakar, MD

Role: CONTACT

052220068 ext. +972

Rami Alaraj, MD candidate

Role: CONTACT

0598488897 ext. +970

Facility Contacts

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Hussein Elkhayat, MD

Role: primary

Ahmed Elkholy, MD

Role: primary

Luca Bertolaccini, MD

Role: primary

Rami Alaraj, MD Candidate

Role: primary

0598488897 ext. 970

Other Identifiers

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02/REC-CT/2021

Identifier Type: -

Identifier Source: org_study_id

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