Health Condition 1: K649- Unspecified hemorrhoids
Conditions
Interventions
Intervention1: NIl: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants aged 18 years or older, regardless of gender who undergo surgical treatment of hemorrhoidal disease throughout the anal canal using the Mirus• Hemorrhoidal Circular Stapler. 2.Participants who are able to give voluntary, written informed consent to participate in this PMCF and from whom consent has been obtained.
Exclusion criteria
Exclusion criteria: 1.Participants who are unwilling or unable to sign the Informed Consent Document. 2.Participants with compressed tissue thickness less than 0.75 mm or greater than 1.5 mm. 3.Participants whose rectum internal diameter will not accommodate the instrument and accessories. 4.Participants with anal stenosis, severe mucosal edema, and severe fibrosis of hemorrhoidal tissue 5.Participants with necrotic or friable tissues and tissues having altered integrity. 6.Participants whose hemorrhoidal tissue has undergone multiple injections of hardening agents. 7.Participants currently undergoing anticoagulation therapy. 8.Participants with any anatomical or pathological condition that would compromise safe stapler placement or function. 9.Participants unable to achieve adequate tissue compression within the specified thickness parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Recurrence Rate 2. Stapled Hemorrhoidopexy ComplicationsTimepoint: 1. Time Frame: 3 months ± 7 days, 6 months ± 7 days, and 1 year ± 30 days. 2.Time Frame: Intra-operative, Discharge, 3 months ± 7 days, 6 months ± 7 days, 1 year ± 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of Life 2.Pain 3.Operative Time 4. Length of Hospital Stay 5. Adverse eventsTimepoint: 1. Time Frame: Baseline, 3 months ± 7 days, 6 months ± 7 days, and 1 year ± 30 days. 2.Time Frame: Baseline, Discharge, 3 months ± 7 days, 6 months ± 7 days, and 1 year ± 30 days 3.Time Frame: Intra-operative 4.Time Frame: Discharge 5.Time Frame: Discharge, 3 months ± 7 days, 6 months ± 7 days, and 1 year ± 30 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed