TonsillitisNCT06494839
Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy
A study testing Bipolar electrocautery tonsillectomy technique and Cold steel dissection technique in people with Tonsillitis, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Bipolar electrocautery tonsillectomy technique and Cold steel dissection technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of 5-13 years of age
- Both genders
- With a history of recurrent episodes of tonsillitis in the last year
- Children who had bilaterally enlarged tonsils
- No history of fever or sore throat in the last 4 weeks
Who cannot join
- Patients who had enlarged adenoids and required adenotonsillectomy
- Patients who underwent tonsillectomy after quinsy
- With a history of bleeding disorders
- Patients who showed an international normalized ratio (INR) ≥ 1.5
Trial locations and contacts
1 site in 1 country.
About this study
It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.
- Conditions
- Tonsillitis
- Being tested
- Bipolar electrocautery tonsillectomy technique, Cold steel dissection technique
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar electrocautery tonsillectomy techniqueProcedure or surgery
The BED tonsillectomy procedures were done under general anesthesia, and the patient's position was the same as in the other method. The bipolar machine was adjusted to 30 watts, and a mucosal incision was cauterized with a single straight or stepped bipolar forceps. After carefully cauterizing the tissue, the palatine tonsil was located and removed from the superior to the inferior pole. Most of the identifiable vessels supplying the tonsil were cauterized before being separated from the tonsil. Point coagulation was used to maintain hemostasis. By using point coagulation, hemostasis was maintained. To avoid bias stemming from competence, consultants performed all of these tonsillectomies.
Cold steel dissection techniqueProcedure or surgery
The cold steel blunt dissection tonsillectomy was carried out under general anesthesia while the patient was in the Rose position and had an endotracheal intubation. The tonsil was retracted medially with a tonsil holding forceps, and in the upper pole, the mucosal incision was made. To protect the tonsillar pillars, a delicate dissection was performed, and the suction tip was used to stop the hemorrhage. The tonsillar fossa was packed with swabs. The other palatine tonsil was then similarly removed. Hemostasis was secured by silk ligation and bipolar electrocautery.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar electrocautery tonsillectomy group | Experimental | Not described Receives: Procedure: Bipolar electrocautery tonsillectomy technique |
| Cold steel dissection group | Experimental | Not described Receives: Procedure: Cold steel dissection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time was measured from the anterior pillar incision to the removal of the mouth gag.
Measured: 1 hour
Blood loss
Intraoperative blood loss was measured by reading the levels given in the suction bottle at the end of surgery. The weight of dry gauze was subtracted from the wet, considering 1g=1ml.
Measured: up to 24 hours
Postoperative pain
Postoperative pain was measured at regular intervals (6-hourly till 24 hours) using the Wong-Baker faces pain rating scale.12 The Wong-Baker faces pain rating scale graded pain as mild (1-3), moderate (4-6), or severe (>6).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494839
- Sponsor's protocol ID
- TonsillectomyLHR
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy
- ClinicalTrials.gov ID
- NCT06494839
- Acronym / sponsor ID
- TonsillectomyLHR
- Conditions
- Tonsillitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar electrocautery tonsillectomy group | Experimental | Procedure: Bipolar electrocautery tonsillectomy technique |
| Cold steel dissection group | Experimental | Procedure: Cold steel dissection technique |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients of 5-13 years of age
- Both genders
- With a history of recurrent episodes of tonsillitis in the last year
- Children who had bilaterally enlarged tonsils
- No history of fever or sore throat in the last 4 weeks
Key exclusion criteria (4 listed)
- Patients who had enlarged adenoids and required adenotonsillectomy
- Patients who underwent tonsillectomy after quinsy
- With a history of bleeding disorders
- Patients who showed an international normalized ratio (INR) ≥ 1.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar electrocautery tonsillectomy techniqueThe BED tonsillectomy procedures were done under general anesthesia, and the patient's position was the same as in the other method. The bipolar machine was adjusted to 30 watts, and a mucosal incision was cauterized with a single straight or stepped bipolar forceps. After carefully cauterizing the tissue, the palatine tonsil was located and removed from the superior to the inferior pole. Most of the identifiable vessels supplying the tonsil were cauterized before being separated from the tonsil. Point coagulation was used to maintain hemostasis. By using point coagulation, hemostasis was maintained. To avoid bias stemming from competence, consultants performed all of these tonsillectomies. | Procedure or surgery | Bipolar electrocautery tonsillectomy group |
| Cold steel dissection techniqueThe cold steel blunt dissection tonsillectomy was carried out under general anesthesia while the patient was in the Rose position and had an endotracheal intubation. The tonsil was retracted medially with a tonsil holding forceps, and in the upper pole, the mucosal incision was made. To protect the tonsillar pillars, a delicate dissection was performed, and the suction tip was used to stop the hemorrhage. The tonsillar fossa was packed with swabs. The other palatine tonsil was then similarly removed. Hemostasis was secured by silk ligation and bipolar electrocautery. | Procedure or surgery | Cold steel dissection group |
Primary outcome
Operative time
Time frame: 1 hour
Operative time was measured from the anterior pillar incision to the removal of the mouth gag.
Blood loss
Time frame: up to 24 hours
Intraoperative blood loss was measured by reading the levels given in the suction bottle at the end of surgery. The weight of dry gauze was subtracted from the wet, considering 1g=1ml.
Postoperative pain
Time frame: 24 hours
Postoperative pain was measured at regular intervals (6-hourly till 24 hours) using the Wong-Baker faces pain rating scale.12 The Wong-Baker faces pain rating scale graded pain as mild (1-3), moderate (4-6), or severe (>6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar electrocautery tonsillectomy technique and Cold steel dissection technique in people with Tonsillitis, run by RESnTEC, Institute of Research at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.