Anal Fistula, Anal Function, Healing Rate, LIFT-plug
Conditions
Keywords
anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function
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
Detailed description
The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment. The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively. The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers.
Interventions
PROCEDURELIFT-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
The Second Artillery General Hospital
Peking University Third Hospital
Beijing Anorectal Hospital
Beijing Luhe Hospital
Beijing Shuyi Hospital
People's Hospital of Beijing Daxing District
Zhen Jun Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomization was performed on the day before surgery through sealed opaque envelopes containing the surgical method. The study was approved by the institutional review boards of the 7 hospitals.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing rate | 6 months postoperatively | the healing rate of two groups in 6 months postoperatively |
| healing time | 6 months postoperatively | the wound healing time from operation to healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain score postoperatively | 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively | visual analog scale scores |
| anal function | 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively | wexner score |
Countries
China
Contacts
Primary ContactJinjie Cui, MD
Outcome results
None listed