NCT04108923

Brief Summary

To compare between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Status
unknown

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

First Submitted

Initial submission to the registry

September 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

September 24, 2019

Last Update Submit

January 6, 2020

Conditions

Thyroid Diseases

Keywords

ThyroidectomyLigasureVessel ligation

Outcome Measures

Primary Outcomes (4)

  • Intraoperative blood loss

    Measuring intraoperative blood loss using surgical towels and contents of suction. Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "

    Baseline

  • Post-operative blood loss

    Measuring postoperative blood loss by measuring contents of drains

    From skin closure until one week post operatively

  • Post-operative complications

    Including RLN palsy , hypocalcemia , hemorrhage wound infection

    Postoperatively from day of surgery until one week post operatively

  • Operation time

    From skin incision to skin closure

    Baseline

Secondary Outcomes (1)

  • Length of hospital stay

    Baseline up to two weeks

Study Arms (2)

Ligasure ( group A)

ACTIVE COMPARATOR
Device: Ligasure

Conventional vessel ligation (group B)

ACTIVE COMPARATOR
Procedure: Conventional vessel ligation

Interventions

LigasureDEVICE

the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall

Ligasure ( group A)
Conventional vessel ligationPROCEDURE

Conventional vessel ligation either tying and /or clipping of blood vessels

Conventional vessel ligation (group B)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
  • Any age

You may not qualify if:

  • patient undergoing re-do surgery " completion thyroidectomy "
  • patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Youssef T, Mahdy T, Farid M, Latif AA. Thyroid surgery: use of the LigaSure Vessel Sealing System versus conventional knot tying. Int J Surg. 2008 Aug;6(4):323-7. doi: 10.1016/j.ijsu.2008.05.005. Epub 2008 May 23.

    PMID: 18585113BACKGROUND

  • Vidal O, Saavedra-Perez D, Valentini M, Astudillo E, Fernandez-Cruz L, Garcia-Valdecasas JC. Surgical outcomes of total thyroidectomy using the LigaSure Small Jaw versus LigaSure Precise: A retrospective study of 2000 consecutive patients. Int J Surg. 2017 Jan;37:8-12. doi: 10.1016/j.ijsu.2016.08.241. Epub 2016 Aug 23.

    PMID: 27565244BACKGROUND

  • Luo Y, Li X, Dong J, Sun W. A comparison of surgical outcomes and complications between hemostatic devices for thyroid surgery: a network meta-analysis. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1269-1278. doi: 10.1007/s00405-016-4190-3. Epub 2016 Aug 1.

    PMID: 27481528BACKGROUND

  • Peker K, Dumanli Ozcan AT, Sahin M, Inal A, Kilic K, Ozcicek F. A comparison of total thyroidectomies carried out through LigaSure and Harmonic Scalpel: a retrospective study. Turk J Med Sci. 2014;44(2):255-60. doi: 10.3906/sag-1210-94.

    PMID: 25536733BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Central Study Contacts

Abadeer Rizallah

CONTACT

+201289028410dr.abadeermarsis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 30, 2019

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

January 7, 2020

Record last verified: 2020-01