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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photosensitive hydrogel | Experimental | The photosensitive hydrogel is composed of tetra-armed poly(ethylene glycol) (4aPEGNB)and methacrylate-modified hyaluronic acid (HAMA).The hydrogel can be rapidly photocured under light induction at 395nm. |
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| Suture fixation | Active Comparator | The suture is fixed with 6-0 absorbable thread. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photosensitive hydrogel | Device | In the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic opening rate | The opening of the anastomosis was observed by nasal endoscopy. | 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of tearing symptoms | The remission of tearing symptoms was assessed by VAS scale | 2, 6 and 12 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | 200031 | China |
We will publish the data in the form of a paper, and other researchers can obtain the required information with the permission of the principal investigator.
1 year
Other researchers can obtain the required information with the permission of the principal investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2023 | Jul 23, 2024 | Prot_000.pdf |
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| 6-0 absorbable stitches | Device | In the suture fixation group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by two stitches using 6-0 absorbable wire. |
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