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The goal of this clinical trial is to compare two surgical procedures in endoscopic adenoidectomy including Coblation and Suction diathermy
. The main questions it aims to answer are: Does the Coblation device have less time, less pain, less postoperative crustation and bad odor, less intraoperative bleeding, and less recurrence?
Participants will:
will undergo both procedures every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients who underwent the adenoidectomy using suction diathermy | Active Comparator | One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine. |
|
| patients who underwent the adenoidectomy using coblation | Experimental | One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATORâ„¢ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adenoidectomy using coblatioion | Procedure | One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATORâ„¢ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative duration | The procedure, from the initial insertion of the Bowel-Davis mouth gag to the complete removal of the adenoid and the gag, was timed in minutes. | During the procedure |
| Intraopertive blood loss | Boezaart surgical field grading scale was used to evaluate the intraoperative bleeding | during the procedures |
| Postopertaive Pain | The Wong-Baker Pain Scale consists of 6 faces depicting different levels of pain. Face 1 represents no pain, Face 2 indicates a little bit of hurt, Face 3 indicates a little more hurt, Face 4 indicates even more hurt, Face 5 indicates a whole lot of hurt, and Face 6 indicates the worst possible hurt, with pain scores ranging from 0 to 10. Both the children and their parents were informed about the purpose of the questionnaires and how to fill them out before the surgery | Patients reported their pain levels every day before taking any pain medication during the 7 days after their surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Development of bad breath | frequency of Children who presented with bad breath | from the end of operation till 2 weeks post operation |
| recovery time | time which was talken for the patients to resume their normal social routines |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alazhar university Hopital in Assiut | Asyut | Egypt |
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|
| adenoidectomy by Suction diathermy | Procedure | One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine. |
|
| three months post opertaive |
| secondary bleeding | frequency of Children who presented with bleeding that occurred after 24 hrs of operation | up to one month surgery |
| Pre- and post-adenoid size grading | The Parikh grading system (1-4) is used to assess the extent of adenoid tissue contact with surrounding structures: Grade 1 - adenoid tissue not in contact, Grade 2 - adenoid tissue in contact with Eustachian tube cushions, Grade 3 - adenoid tissue in contact with vomer, Grade 4 - adenoid tissue in contact with soft palate | preintervention (one day before opertaion ) and postintervention (up to three months) |