Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

384

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

January 1, 2018

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed

Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

March 13, 2020

Last Update Submit

March 13, 2020

Conditions

Anal Fistula LIFT-plug Healing Rate Anal Function

Keywords

anorectal fistulaLIFT-plugcomplications of treatmenthealing rateanal function

Outcome Measures

Primary Outcomes (2)

Healing rate
the healing rate of two groups in 6 months postoperatively
6 months postoperatively
healing time
the wound healing time from operation to healing
6 months postoperatively

Secondary Outcomes (2)

anal function
5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
pain score postoperatively
5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively

Study Arms (2)

LIFT-plug

EXPERIMENTAL

The LIFT-plug procedure was performed as followings. A portion of the fistula tract was excised from ei¬ther end within the intersphincteric space. One porcine 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.

Procedure: LIFT-plug technique

LIFT

EXPERIMENTAL

The LIFT procedure was performe as followings. The curvilinear incision and dissection of the intersphincteric tract were made as in the LIFT-plug technique. After the tract was isolated, the tract was doubly-ligated and suture-ligated with absorbable sutures as close as possible to the lateral margin of the internal anal sphincter and the medial margin of the external anal sphincter. The tract was then divided between the two sutures. A portion of the fistula tract was excised after ligation of ei¬ther end within the intersphincteric space. The medial ligature was very close to the internal opening, and nearly obliterated the internal opening. The external opening was then enlarged to allow adequate drainage. The internal and external sphincters were then re-approximated, and the skin was closed loosely with interrupted 3/0 absorbable suture.

Procedure: LIFT-plug technique

Interventions

LIFT-plug techniquePROCEDURE

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

LIFTLIFT-plug

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

High transsphincteric fistula (involving \> 30% of the external anal sphincter)
Age between 18 and 70 years
Chronic anal fistula with fistula tracts no more than 2
No active sepsis or abscess

You may not qualify if:

Fistulas with active inflammation or purulence
Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome
Poorly controlled diabetes with fasting blood-glucose \> 8mmol/L
Preexisting incontinence
Multiple fistula tracts \> 2
Fasting blood-glucose ≥ 8mmol/L
Allergic or contraindication for the use of animal protein
Pregnant women
Expected life less than 6 months
With anorectal abscess
Serious liver (Child-Pugh C) and chronic kidney disease (CKD) stage 3

Contact the study team to confirm eligibility.