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Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy

Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06494839
Enrollment
110
Registered
2024-07-10
Start date
2023-11-01
Completion date
2024-04-30
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillitis

Brief 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. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.

Interventions

PROCEDUREBipolar electrocautery tonsillectomy technique

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.

PROCEDURECold steel dissection technique

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 The tonsil was retracted medially with a tonsil holding forceps, and in the upper pole, the mucosal incision was made.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.

Sponsors

RESnTEC, Institute of Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Operative time1 hourOperative time was measured from the anterior pillar incision to the removal of the mouth gag.
Blood lossup to 24 hoursIntraoperative 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 pain24 hoursPostoperative 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).

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026