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LIFT-plug vs LIFT, a RCT Trial

NCT04310800 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2020-03-17

No results posted yet for this study

Summary

To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers

Conditions

  • Anal Fistula
  • LIFT-plug
  • Healing Rate
  • Anal Function

Interventions

PROCEDURE

LIFT-plug technique

Small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures

Sponsors & Collaborators

  • The Second Artillery General Hospital

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • Beijing Anorectal Hospital

    collaborator OTHER

  • Beijing Luhe Hospital

    collaborator OTHER

  • Beijing Shuyi Hospital

    collaborator OTHER

  • People's Hospital of Beijing Daxing District

    collaborator OTHER

  • Zhen Jun Wang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT04310800 on ClinicalTrials.gov