An interventional study of Bipolar electrocautery tonsillectomy technique and Cold steel dissection technique in Tonsillitis, sponsored by RESnTEC, Institute of Research. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by RESnTEC, Institute of Research · Not applicable, Interventional, and Treatment
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 110 is close to the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →RESnTEC, Institute of Research is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Bipolar electrocautery tonsillectomy technique
Procedure: Cold steel dissection 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.
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.
Operative time
Operative time was measured from the anterior pillar incision to the removal of the mouth gag.
Time frame: 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.
Time frame: 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).
Time frame: 24 hours
Plan to share: No — Data can be shared with other researchers on a reasonable request.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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RESnTEC, Institute of Research