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Anal Fistula Plug, a Retrospective Study

NCT04319861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2020-03-24

No results posted yet for this study

Summary

In this study, we retrospectively reviewed clinical data of patients who were treated with an anal fistula plug for trans-sphincteric anal fistulas, and evaluated the long-term therapeutic effect of an anal fistula plug and the risk factors impacting anal fistula healing. In addition, we assessed the effects of post-operative changes on anal function, as well as the risk factors affecting anal function.

Conditions

  • Healing Rate
  • Recurrence
  • Complication

Interventions

PROCEDURE

Anal fistula plug procedure

A fistula probe was used to identify fistula tracts, and internal and external openings. Gentle mechanical debridement was performed with a blunt curette to remove the necrotic tissue with care not to enlarge the track, then hydrogen peroxide and sterile saline were used to repeatedly to irrigate the fistula. The anal fistutla plug was filled into the fistula, and sutured with a figure-of-eight 2-to-0 Vicryl suture to ensure the plug was fixed in the internal opening of the fistula, avoiding the anal fistula plug being extruded. Trimming the plug at the external fistula and the external opening was left open to ensure adequate drainage.

Sponsors & Collaborators

  • Zhen Jun Wang

    lead OTHER

Principal Investigators

  • Jiagang Han · Beijing Chao Yang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-01
Primary Completion
2018-11-20
Completion
2019-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04319861 on ClinicalTrials.gov