NCT00636402

Brief Summary

This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 11, 2008

Status Verified

December 1, 2008

Enrollment Period

9 months

First QC Date

March 7, 2008

Last Update Submit

December 10, 2008

Conditions

TonsillitisObstructive Sleep Apnea

Keywords

Vessel Sealing SystemCold KnifeTonsillectomyPainPostoperative

Outcome Measures

Primary Outcomes (3)

  • Intra-operative time

    1 day

  • Intra-operative blood loss

    1 day

  • Pain, postoperative

    14 days

Secondary Outcomes (1)

  • Postoperative bleeding and other adverse effects

    14 days

Study Arms (2)

1

EXPERIMENTAL

Vessel Sealing System Tonsillectomy (VSST)

Procedure: Vessel Sealing System Tonsillectomy

2

ACTIVE COMPARATOR

Cold Knife Tonsillectomy (CKT)

Procedure: Cold Knife Tonsillectomy

Interventions

Cold Knife TonsillectomyPROCEDURE

Cold Knife Tonsillectomy (CKT) will be done on the other side.

Also known as: CKT
2
Vessel Sealing System TonsillectomyPROCEDURE

Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.

Also known as: VSST
1

Eligibility Criteria

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

You may qualify if:

  • Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea
  • Written informed consent form is given from patient or patient's parents (in case of pediatric patient)

You may not qualify if:

  • Pregnancy
  • History of bleeding disorders
  • Unilateral tonsillectomy
  • Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study)
  • Patient unable to understand evaluation method
  • Patient unable to be contacted via telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (5)

  • Lachanas VA, Hajiioannou JK, Karatzias GT, Filios D, Koutsias S, Mourgelas C. Comparison of LigaSure vessel sealing system, harmonic scalpel, and cold knife tonsillectomy. Otolaryngol Head Neck Surg. 2007 Sep;137(3):385-9. doi: 10.1016/j.otohns.2007.05.012.

    PMID: 17765762RESULT

  • Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. doi: 10.1097/01.mlg.0000172044.57285.b6.

    PMID: 16148700RESULT

  • Prokopakis EP, Lachanas VA, Benakis AA, Helidonis ES, Velegrakis GA. Tonsillectomy using the Ligasure vessel sealing system. A preliminary report. Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1183-6. doi: 10.1016/j.ijporl.2005.03.042.

    PMID: 15961165RESULT

  • Lister MT, Cunningham MJ, Benjamin B, Williams M, Tirrell A, Schaumberg DA, Hartnick CJ. Microdebrider tonsillotomy vs electrosurgical tonsillectomy: a randomized, double-blind, paired control study of postoperative pain. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):599-604. doi: 10.1001/archotol.132.6.599.

    PMID: 16785404RESULT

  • Newman CJ, Lolekha R, Limkittikul K, Luangxay K, Chotpitayasunondh T, Chanthavanich P. A comparison of pain scales in Thai children. Arch Dis Child. 2005 Mar;90(3):269-70. doi: 10.1136/adc.2003.044404.

    PMID: 15723913RESULT

MeSH Terms

Conditions

TonsillitisSleep Apnea, ObstructivePain

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prakobkiat Hirunwiwatkul, M.D.

    Faculty of Medicine, Chulalongkorn University, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 11, 2008

Record last verified: 2008-12

Locations

TH(1)