NCT03886519

Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 886 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.

Detailed description

The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.

Conditions

• Trichiasis
• Surgery

Interventions

Type	Name	Description
PROCEDURE	BRAP (Bevel/rotate/advance procedure)	Trichiasis surgery using the BRAP procedure
PROCEDURE	Trabut	Trichiasis surgery using the Trabut procedure

Timeline

• Start date: 2019-04-13
• Primary completion: 2022-10-22
• Completion: 2022-10-22
• First posted: 2019-03-22
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

1 site across 1 country: Ethiopia