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Study to evaluate safety of BEST surgery in complex fistula

A Prospective Non-comparative Study to evaluate the efficacy and safety of BEST Balloon Expansion and Separation Technique Surgery by using special tube drain called as BEST device in all types of complex fistula in ano

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041736
Enrollment
50
Registered
2022-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: K605- Anorectal fistula

Interventions

Intervention1: BEST Device: Balloon Expansion & Seperator Technique used.Balloon kept for 2-3 weeks. Control Intervention1: NIL: NIL

Sponsors

Healing Hands Clinic
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18-80 years Patients with all types of complex fistula fistula associated with multiple tracts horse shoe fistulas Recurrent fistulas anterior fistulas in females fistula with long tracts Fistula with supralevator blind extension fistula where internal opening cannot be localised fistula associated with abscess or pus collection

Exclusion criteria

Exclusion criteria: Uncomplicated fistula cured by simple fistulotomy history of inflammatory bowel disease Chronic immunosuppresive treatment untreated cancer or cancer treated or dignosed within 6 months Incompetent subject pregnancy any clinical condition,according to the investigator which does not allow safe fulfillment of the study protocol

Design outcomes

Primary

MeasureTime frame
Evaluate the time to heal anal fistula Evaluate and compare VAS pain score To evaluate anal fistula recurrence rate Timepoint: 6 months

Secondary

MeasureTime frame
To correlate preoperative endoscopic findings with intraoperative findings To determine length of hospital stay To determine incidence of postoperative complicationsTimepoint: 7 day,15 day,1 month,3 month,6 months,12 month

Countries

India

Contacts

Public ContactDr Ashwin Porwal

Healing Hands Clinic

drashwinporwal@gmail.com9822347770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026