External Versus Powered Endoscopic Dacryocystorhinostomy, Both With Intraoperative Mitomycin C, for Primary Acquired Nasolacrimal Duct Obstruction: A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anatomical Patency of the Rhinostomy
研究概览
简要总结
Primary acquired nasolacrimal duct obstruction causes persistent tearing because tears cannot drain normally from the eye into the nose. The purpose of this randomized study was to compare two operations used to restore tear drainage: external dacryocystorhinostomy, performed through a small skin incision near the inner corner of the eye, and powered endoscopic dacryocystorhinostomy, performed through the nose using an endoscope and powered instruments, with mitomycin C applied during surgery to reduce scar formation.
Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in each group. Participants were followed for 12 months after surgery.
The main outcomes were whether the newly created tear drainage opening remained open and whether tearing symptoms improved. Additional assessments included postoperative symptom severity, patient satisfaction, surgical complications, cosmetic concerns related to the external scar, and willingness to undergo the same procedure again.
详细描述
This was a prospective, randomized, single-center clinical study involving patients with primary acquired nasolacrimal duct obstruction. The study compared external dacryocystorhinostomy with powered endoscopic dacryocystorhinostomy performed with intraoperative application of mitomycin C.
Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in the external dacryocystorhinostomy group and 30 participants in the powered endoscopic dacryocystorhinostomy group.
Participants were followed for 12 months after surgery. Anatomical success was defined as a patent rhinostomy opening confirmed by nasal endoscopic examination and lacrimal irrigation. Functional success was defined as a postoperative Munk score of 1 or lower. Overall surgical success required both anatomical and functional success.
Additional assessments included postoperative Munk score, complete resolution of tearing defined as a Munk score of 0, patient satisfaction, willingness to undergo the same procedure again, postoperative complications, and cosmetic concerns related to the external surgical scar.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Unilateral or bilateral pathological epiphora not expected to improve with conservative treatment.
- •Confirmed primary acquired obstruction at the level of the lacrimal sac or nasolacrimal duct, with an indication for dacryocystorhinostomy.
- •General health status permitting surgery under general anesthesia and participation in the 12-month follow-up.
- •Ability to understand the study requirements and comply with the scheduled study procedures and follow-up visits.
- •Written informed consent to participate in the study and undergo surgery.
排除标准
- •History of previous lacrimal drainage surgery, including external, endoscopic, or laser-assisted dacryocystorhinostomy.
- •Acute inflammation or infection of the lacrimal drainage system, nasal cavity, or paranasal sinuses.
- •Suspected neoplastic lesion of the lacrimal drainage system, nasal cavity, or paranasal sinuses.
- •Clinically significant abnormalities of the eyelids or ocular adnexa that could contribute to epiphora.
- •History of eyelid surgery.
- •Documented hypersensitivity to mitomycin C or any medication used during the preoperative, intraoperative, or postoperative procedures.
- •Cognitive impairment, psychiatric disorder, or emotional instability preventing valid informed consent or adherence to the study procedures.
- •Inability or unwillingness to comply with the scheduled examinations and follow-up visits.
- •General medical condition precluding surgery under general anesthesia.
- •Serious life-limiting disease or another medical condition preventing completion of the 12-month follow-up.
- •Pregnancy or breastfeeding.
- •Women of childbearing potential not using an accepted method of contraception.
研究组 & 干预措施
External Dacryocystorhinostomy With Mitomycin C
Participants assigned to this arm underwent external dacryocystorhinostomy with intraoperative application of mitomycin C.
干预措施: External Dacryocystorhinostomy (Procedure)
External Dacryocystorhinostomy With Mitomycin C
Participants assigned to this arm underwent external dacryocystorhinostomy with intraoperative application of mitomycin C.
干预措施: Mitomycin C 0.02% (Drug)
Powered Endoscopic Dacryocystorhinostomy With Mitomycin C
Participants assigned to this arm underwent powered endoscopic dacryocystorhinostomy with intraoperative application of mitomycin C.
干预措施: Powered Endoscopic Dacryocystorhinostomy (Procedure)
Powered Endoscopic Dacryocystorhinostomy With Mitomycin C
Participants assigned to this arm underwent powered endoscopic dacryocystorhinostomy with intraoperative application of mitomycin C.
干预措施: Mitomycin C 0.02% (Drug)
结局指标
主要结局
Anatomical Patency of the Rhinostomy
时间窗: 12 months after surgery
Number of participants with a patent rhinostomy ostium confirmed by both nasal endoscopic examination and lacrimal irrigation.
Epiphora Severity Assessed by the Munk Score
时间窗: 12 months after surgery
Epiphora severity was assessed using the Munk score ranging from 0 to 5. A score of 0 indicated no tearing, and a score of 5 indicated constant tearing requiring continuous wiping. Lower scores indicated less severe epiphora.
次要结局
- Patient-Reported Perceived Surgical Effectiveness(3 to 4 months after surgery)
- Patient-Reported Epiphora Burden(3 to 4 months after surgery)
- Fluorescein Dye Disappearance Test Score(3 to 4 months after surgery)
- Rhinostomy Ostium Width(12 months after surgery)
- Discomfort Associated With Crawford Tube Intubation(3 to 4 months after surgery)