Endoscopic Coblation Versus Suction Diathermy in Pediatric Adenoidectomy: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Operative duration
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients aged 2 to 18 years
- •patients who had isolated adenoid hypertrophy
- •patients' hemoglobin levels above 10 mg/dl
排除标准
- •those with recent upper respiratory tract infections, evidence of bleeding disorders, serous otitis media, chronic tonsillitis
- •those advised against undergoing adenoidectomy after consulting a phoniatrist
- •patients with atrophic rhinitis those with nasal obstruction caused by other nasal or paranasal conditions such as inferior turbinate hypertrophy, Choanal atresia, deviated nasal septum, antrochoanal polyps, and other causes of nasal obstruction in children.
研究组 & 干预措施
patients who underwent the adenoidectomy using suction diathermy
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.
干预措施: adenoidectomy by Suction diathermy (Procedure)
patients who underwent the adenoidectomy using coblation
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 COBLATOR™ 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.
干预措施: adenoidectomy using coblatioion (Procedure)
结局指标
主要结局
Operative duration
时间窗: During the procedure
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.
Intraopertive blood loss
时间窗: during the procedures
Boezaart surgical field grading scale was used to evaluate the intraoperative bleeding
Postopertaive Pain
时间窗: Patients reported their pain levels every day before taking any pain medication during the 7 days after their surgery
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
次要结局
- Development of bad breath(from the end of operation till 2 weeks post operation)
- recovery time(three months post opertaive)
- secondary bleeding(up to one month surgery)
- Pre- and post-adenoid size grading(preintervention (one day before opertaion ) and postintervention (up to three months))
研究者
Ahmed Nabil Selim
Resident doctor of otorhinolanrgology at alazhar univeristy hopsital in assiut
Al-Azhar University