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. 2020 Apr 7;2020(4):CD012309. doi: 10.1002/14651858.CD012309.pub2

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
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
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
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora

  • postoperative patency using sac syringing under endoscopic vision

  • ostium size on nasal endoscopy postoperatively


Adverse events: immediate postoperative orbital emphysema, synechiae formation, granulation formation in a stoma site
Identification Author name: Shrinivas‐Shripatrao Chavan
Institution: Grant Medical College And Sir Jj Group Of Hospitals
Email: shrinivasc77@hotmail.com
Notes Funding source: not reported
Declarations of interest: not reported
Trial registration number: not reported
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'.