Study Comparing Harmonic Scalpel and Conventional Cold Steel Tonsil Removal Surgery in Children Requiring Tonsillectomy
Comparison of Harmonic Scalpel Versus Cold Steel Dissection Tonsillectomy in Children
This clinical trial aims to compare two commonly used methods of tonsil removal surgery (tonsillectomy) in children and adults with chronic tonsillitis. Chronic tonsillitis refers to repeated episodes of tonsil infection that occur frequently over several years and require surgical removal of the tonsils.
The main question this study aims to answer is:
Does tonsillectomy performed with a harmonic scalpel result in less pain three days after surgery compared with the conventional cold steel dissection technique?
Researchers will also compare:
How long the surgery takes to perform How much blood is lost during the operation The level of pain experienced three days after surgery
A total of 66 participants aged 5 to 45 years who are scheduled for tonsillectomy because of chronic tonsillitis will take part in the study. Participants will be randomly assigned to undergo either conventional cold steel dissection tonsillectomy or harmonic scalpel tonsillectomy.
All surgeries will be performed by experienced ENT surgeons following standard hospital procedures. After surgery, participants will receive routine medications and instructions for home care. They will be followed for three days and then return to the ENT clinic for assessment of pain and examination of the healing of the surgical site.
The study hypothesis is that patients undergoing harmonic scalpel tonsillectomy will experience less pain three days after surgery than those undergoing conventional cold steel dissection tonsillectomy.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Punjab Province
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Dera Ghazi Khan, Punjab Province, Pakistan, 32200
- Allama Iqbal Teaching Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- chronic tonsillitis and planned for tonsillectomy
Exclusion Criteria:
- Upper respiratory tract infection within preceding three weeks
- Peritonsillar abscess or history of quinsy
- Known bleeding disorder (hemophilia, thrombocytopenia) or on anticoagulant therapy
- Craniofacial anomalies or syndromic conditions affecting airway or surgical anatomy
- Uncontrolled diabetes, severe cardiopulmonary disease
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Cold Steel Dissection Tonsillectomy
Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy.
|
The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol.
|
|
Experimentell: Harmonic Scalpel Tonsillectomy
Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel
|
A harmonic scalpel with a curved blade (Ethicon Endosurgery, Johnson & Johnson, USA) will be used for dissection and hemostasis (using ultrasonic energy) during tonsil removal.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Pain Score
Tidsram: From surgery (day of tonsillectomy) to three (03) days postoperatively
|
Postoperative pain will be assessed three days after tonsillectomy using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst tolerable pain.
Mean VAS scores will be compared between the harmonic scalpel and cold steel dissection groups.
|
From surgery (day of tonsillectomy) to three (03) days postoperatively
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Operative Time
Tidsram: During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
|
Duration of surgery measured in minutes from the start of tonsil dissection to completion of surgery and achievement of hemostasis.
|
During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
|
|
Intraoperative Blood Loss
Tidsram: During the surgical procedure (from start of dissection to completion of hemostasis).
|
Blood loss measured in milliliters using suction canister and pre-weighed sponges (1 g increase = 1 mL blood).
|
During the surgical procedure (from start of dissection to completion of hemostasis).
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Sharbaz H Khosa, FCPS, Allama Iqbal Teaching Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- U1111-1342-4276
Plan för individuella deltagardata (IPD)
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