Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04886440

Acronym

SIAGLA

Enrollment

138

Registered

2021-05-14

Start date

2021-01-01

Completion date

2021-03-25

Last updated

2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lithiasis

Keywords

sialendoscopy, submandibular gland, classification

Brief summary

Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland. The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure. Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patient * Patient treated in CHR Metz-Thionville between 2013 and 2020 * With a pathological impairment (suspected or confirmed) of a salivary gland * With sialendoscopy indication for diagnosis and/or treatment

Exclusion criteria

* Opposed to use data * Without sialendoscopy indication * Without lithiasis salivary gland disorder * With parotid gland lithiasis

Design outcomes

Primary

Measure	Time frame	Description
Recurrence of symptom	Month 6	Absence or presence of symptoms associated to lithiasis

Secondary

Measure	Time frame	Description
Number of clinical signs	Day 1	number of clinical signs of the clinical suspicion
Number of intraoperative complications	Day 1	number of intraoperative complications
Number of post-operative complications	Day 1	Number of post-operative complications

Countries

France

Outcome results