Clinical trial NCT06551766: The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy
Official title: The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy for the Anastomosis of Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Dacryocystitis
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of Photosensitive hydrogel used for suture free anastomosis of lacrimal cyst and nasal mucoperiosteal flap in endoscopic nasal dacryocystostomy, and evaluate its adhesion to lacrimal cyst and nasal mucoperiosteal flap, promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and shortening operation time. Twenty patients with chronic dacryocystitis were randomly divided into photosensitive hydrogel group and suture group.Symptoms and nasal endoscopy were followed up 2, 6, and 12 weeks after surgery for both groups. And also adverse events were recorded at each follow-up.

Detailed description: After endoscopic dacryocystonasal anastomosis, granulation and/or cicatricial adhesion are the main reasons for surgical failure. How to achieve the ideal fit between the lacrimal sac flap and the nasal mucoperiosteal flap and avoid the proliferation of granulation and cicatricial adhesion is very important for the success of the operation. In this study, "photocoupling reaction" technology was used to achieve seamless integration and strong adhesion of photosensitive hydrogel materials to the wound, and the photohydrogel was applied to suture free adhesion and wound repair of the lacrimal cyst mucosal flap and nasal mucosal flap in endoscopic nasal Dacryocystostomy (En-DCR), and its feasibility, safety and effectiveness were evaluated.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate in this clinical study and sign the informed consent;
2. Gender is not limited, age 18-75 years old;
3. The patient had symptoms and signs of chronic dacryocystitis, and the results of lacrimal passage irrigation suggested that the lower rush and return or upper rush and lower return, accompanied by mucous or purulent discharge reflux;
4. Lacrimal duct angiography suggests nasolacrimal duct obstruction without lacrimal canaliculi and/or duct obstruction.

Exclusion Criteria:

1. Age \< 18 or \> 75 years old;
2. Previous history of dacryocystonasal anastomosis;
3. Abnormal coagulation function;
4. Tumors of lacrimal passage, especially in patients with papilloma or malignant tumors;
5. in the acute dacryocystitis attack stage;
6. obvious scar constitution;
7. Complicated with serious nasal diseases, such as severe allergic rhinitis, chronic rhinosinusitis and nasal polyps, acute suppurative rhinosinusitis, severe atrophic rhinitis, and severe deviation of nasal septum;
8. Have serious heart, liver, kidney, lung and other basic diseases, can not tolerate general anesthesia;
9. Distance from the hospital, postoperative review is not convenient;
10. Participated in other clinical trials within the last 3 months;
11. Any medical history that the investigator determines may interfere with the test results or increase the patient's risk.

Primary outcomes:
measure: Anastomotic opening rate
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Remission rate of tearing symptoms
timeFrame: 2, 6 and 12 weeks after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
Study officials:
References: