NCT03915093

Brief Summary

video-assisted thoracic surgery (VATS) is a new approach used in cardio thoracic surgery department instead of thoracotomy to treat several diseases.patients underwent thoracoscopic surgery without organized educational protocol either before or after the procedure. Therefore, this study will be the first clinical research which will increase patients' knowledge about thoracoscopy and decrease its complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

April 10, 2019

Last Update Submit

April 11, 2019

Conditions

Keywords

ThoracoscopyEducational nursing protocolQuality of life

Outcome Measures

Primary Outcomes (1)

  • Effect of prehabilitation on quality of life after thoracoscopic surgery

    WHOQOL developed by WHO (2004). It contains 5 broad domains of QOL within which 18 facets are covered to determine the quality of life. These 5 domains include physical, social, psychological, environmental and perceived QOL. Within each domain several sub domains (facets) of QOL Summarize that particular domain of QOL.The scoring of these variables, a 3-point lickert scale on tables was adopted for the answer low QOL=0-3, moderate QOL=4-6, and high QOL =7-9.

    after one month postoperative

Secondary Outcomes (1)

  • effect of prehabilitation on duration of hospital stay after thoracoscopic surgery

    immediate post operative

Study Arms (2)

study group

EXPERIMENTAL

receive educational nursing protocol

Other: Educational nursing protocolOther: Routine hospital care

control group

ACTIVE COMPARATOR

receive routine hospital care

Other: Routine hospital care

Interventions

It is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions

study group

The routine care given by physicians and nurses after thoracoscopic surgery

control groupstudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergoing thoracoscopic surgery
  • Age 18-65 year
  • patients who agree to participate in the study

You may not qualify if:

  • converting to thoracotomy
  • patients refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut U

Asyut, Egypt

Location

Related Publications (2)

  • Yeung WW. Post-operative care to promote recovery for thoracic surgical patients: a nursing perspective. J Thorac Dis. 2016 Feb;8(Suppl 1):S71-7. doi: 10.3978/j.issn.2072-1439.2015.10.68.

    PMID: 26941973BACKGROUND
  • Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.

    PMID: 26273399BACKGROUND

Study Officials

  • Hussein El Khayat

    faculty of medicine

    STUDY DIRECTOR
  • Sahra Azer

    faculty of nursing

    STUDY DIRECTOR
  • Magda Mohamed

    faculty of nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 16, 2019

Study Start

October 4, 2017

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations