LIFT-plug vs LIFT, a RCT Trial (LIFT 02)
Anal Fistula, LIFT-plug, Healing Rate
About this trial
This is an interventional treatment trial for Anal Fistula focused on measuring anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Anorectal HospitalRecruiting
- Beijing Luhe HospitalRecruiting
- Beijing shunyi district hospitalRecruiting
- Peking University Third HospitalRecruiting
- Rocket force general hospitalRecruiting
- Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
- Beijing daxing district people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
LIFT-plug
LIFT
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.
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.