Chavan 2018.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 150 total, 50 per group Number of arms: 3 Enrollment start year: 2014 Length of follow‐up: 150 days Sample size calculations: not reported Losses to follow‐up: 20 in Group 1, 5 in Group 2, 12 in Group 3 |
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Participants |
Country: India Age (mean (SD)): not reported Females (n (%)): 98 (65.3) total Inclusion criteria: aged 6 to 70 years, acquired nasolacrimal duct obstruction with or without mucopurulent discharge, delayed regurgitation with or without mucopurulent discharge from the opposite punctum on sac syringing examination Exclusion criteria: other causes of epiphora (e.g. eyelid malposition, entropion), sac syringing examination confirming common canalicular block, revision endonasal DCR, secondary nasolacrimal duct block due to nasolacrimal duct trauma or total maxillectomy Study group differences: not reported |
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Interventions |
Intervention 1: Group 1: endonasal DCR with MMC application at the stoma site Intervention 2: Group 2: endonasal DCR with silicon tubing to keep the stoma site patent for a period of 6 weeks Comparison intervention: conventional endonasal DCR leaving the wide neo‐ostium unchanged |
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Outcomes |
Measured outcomes:
Adverse events: immediate postoperative orbital emphysema, synechiae formation, granulation formation in a stoma site |
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Identification |
Author name: Shrinivas‐Shripatrao Chavan Institution: Grant Medical College And Sir Jj Group Of Hospitals Email: shrinivasc77@hotmail.com |
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Notes |
Funding source: not reported Declarations of interest: not reported Trial registration number: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization method was not reported. Although the authors state that "patients were randomly divided into three groups of 50 patients each based on a colored chit allocation", there is no indication of how participants were assigned colored chits. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment mechanism is unclear. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study personnel were not masked to the intervention since they had to perform different surgical techniques. Unclear whether participants were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether outcome assessors were masked to the intervention. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing data were not balanced across intervention arms. Reasons for missing data are not explained. |
Selective reporting (reporting bias) | Unclear risk | No trial or protocol registration available for comparison to ascertain selective outcome reporting. |
Other bias | Unclear risk | There was insufficient information to permit a judgement of 'low risk' or 'high risk'. |