Table 3.
Selected outcomes of intersphincteric ligation procedures for complex cryptoglandular fistulas
| Author, year | Exposure groups (patients with CCF only) | Key outcome definitions | Healing/success | Recurrence/failure | Fecal incontinence | Pain |
|---|---|---|---|---|---|---|
| LIFT and BioLIFT (n = 7) | ||||||
| Deimel 2016 | 42; n = 40 had follow-up information; all had high transsphincteric fistula and had modified LIFT | Recurrence was not defined | Not reported |
Note: 95.2%a (40/42) patients had follow-up information, so the denominator changed from 42 to 40 Recurrence rate after mean follow-up time of 14.2 months 7.5% (3/40) All 3 recurrences occurred in female patients (recurrence rate 21%b vs 0%, P = 0.037) |
Not reported | Not reported |
| El Rhaoussi 2019 | LIFT, n = 28 |
Healing: absence of purulent discharge or proctalgia 3 months after surgery Relapse not defined Wexner to assess fecal incontinence |
Healing rate after a median follow-up of 12 weeks 57.1% (16/28) |
Of the 16 patients who healed, relapse rate after an average follow-up of 18 months 0% Of the other 12 patients, 42.9% (12/28) relapsed within 12 weeks |
No cases of anal incontinence were noted with a Cleveland score of 0 before and after the LIFT | Not reported |
| Lau 2020 |
Total n = 116 91%a (105/116) received LIFT as the primary procedure. LIFT was primarily performed on patients with transsphincteric fistulas with associated low resting anal sphincteric pressures. 7 out of these 105 later received BioLIFT as the subsequent intervention 9%a (11/116) received BioLIFT as the primary procedure. 1 out of these 11 patients received LIFT as the subsequent intervention |
Primary healing rate at 6 months: determined clinically by closure of external opening and the absence of clinical symptoms and radiologically by the discontinuity of fistula tract on endoanal ultrasound Secondary healing rates: conversion to intersphincteric fistula and subsequent fistulotomy Failure: fistulas that failed to heal (ongoing presence of external opening or persistence of fistula tract on endoanal ultrasound) or require other definitive procedures other than fistulotomy Incontinence scale not reported |
The p values between LIFT and BioLIFT are also reported: Total primary healing rate 60.3% (70/116) Primary healing rate in LIFT group 62.9% (66/105) Primary healing rate in BioLIFT group 36.4% (4/11); p value = 0.087 Total secondary healing rate 80.1% (93/116) in Table 2; BUT they reported 80.1% (n = 103) in the results Secondary healing rate in LIFT group 80.0% (84/105) Secondary healing rate in BioLIFT group 81.9% (9/11); p value = 0.886 In the 21 patients who had persistent transsphincteric fistula, 33.3%a (7/21) were treated successfully with a BioLIFT procedure |
Median time to primary failure in all 9.28 (range 1–160) weeks Median time to primary failure in LIFT 10.2 (range 1–55) weeks Median time to primary failure in BioLIFT 17.1 (range 9–160) weeks; p value = 0.121 Persistence failure in all 12.9% (15/116) Persistence failure in LIFT group 13.3% (14/105) Persistence failure in BioLIFT group 9.1% (1/11); no p value reported |
Postoperative self-reported Incontinence rate 0% |
Not reported |
| Schulze 2015 | n = 75 |
Success: healing of the external opening and intersphincteric incision with resolution of symptoms Recurrences classified as: Type 1, a residual sinus tract from the external opening Type 2, a downstaged tract from transsphincteric to intersphincteric fistula Type 3, a complete failure with the recurrent fistula tract extending from internal to external opening Wexner used to assess fecal incontinence Pain assessment not described |
No recurrence: Overall 88%a (66/75) Standard LIFT 91.7%a (66/72) 2 LIFT procedures performed simultaneously for multiple tracts 0%a (0/3) |
Overall recurrence rate 12% (9/75) Mean time to recurrence 9.2 months (SEM 2.7 months) Recurrence by intervention: Standard LIFT 8.3%a (6/72) 2 LIFT procedures performed simultaneously for multiple tracts: 100%a (3/3) p < 0.001, Fisher’s exact test |
Cleveland Clinic Florida Fecal Incontinence score (CCF-FI) Preoperative continence score (Wexner) mean 0.55, SEM 0.3 Postoperative continence score (Wexner) mean 0.60, SEM 0.3 No significant difference in preoperative and postoperative continence scores [mean 0.55 (range 0–11) vs mean 0.60 (range 0–11), p = 0.317] 1.3% (1/75) reported increased incontinence following LIFT with a change in continence score from 6 to 8 |
No scale or method of assessment mentioned Perianal pain 3% (2/75) |
| Sun 2019 | n = 70 |
Healing: cicatrization of the intersphincteric wound and the original external opening without discharge at 3 months Failure: persistence of any unhealed wound at 3 months Recurrence: purulent discharge was observed from any previously healed wound Relapse: a new fistula away from the healed one by LIFT Wexner used to assess fecal incontinence Fecal incontinence quality of life (FIQL) used for QoL |
Note: Total patients n = 70, total fistulas/total number of LIFT procedures n = 71 1. Healing rate after initial LIFT, after 12 months 81.7% (58/71) fistulas, without need for further intervention 2. Healing rate by maturity In mature fistulas 83.7% (41/49) In immature fistulas 77.3% (17/22) 3. Primary healing rate in patients who were followed more than 12 months (54 patients with 55 fistulas) 80% (44/55) 4. “The wound healed uneventfully” in 67.1%a (47/70) patients 5. Among the 12 fistulas that recurred as intersphincteric fistulas: 83.3%a (10/12) were successfully healed with fistulotomy 16.7% a (2/12) were asymptomatic and had no treatment 6. 1 failed high transsphincteric fistula (HTF) was healed with the loose-seton technique for external sphincter preservation 7. 1 new low transsphincteric fistula relapsed 19 months after LIFT and was healed with fistulotomy |
Failure rate after initial LIFT 2.8%a (2/71) fistulas Recurrence 15.7%a (11/70) with a median to recurrence time of 5 (range 4–22) months 1 recurrence occurred after 12 months Recurrent fistulas were all downstaged to intersphincteric fistulas Relapse rate 1.4%a (1/70) |
Wexner score (range) Preoperatively 0 (0–2) Postoperatively 0 (0–1) p value 0.414 Incontinence of flatus (% of patients) Improvement after LIFT 5.7%a (4/70) New cases after LIFT plus fistulotomy 2.9%a (2/70) Note: Authors do not indicate whether these are mean or median scores |
Not reported |
| Wen 2018 | n = 62 had modified LIFT |
Success: complete healing of the surgical intersphincteric wound and the external opening without any sign of recurrence Failure: a clinical diagnosis of fistula recurrence at any time in the postoperative follow-up defined by clinical interview, physical examination Wexner used to assess fecal incontinence after the operation and in the end of the follow-up |
Success after first LIFT procedure 83.9% (52/62) Success after LIFT and second procedure 100%a (62/62) Fistulotomy 100%a (8/8; all male) Cutting seton 100%a (2/2; both female) Success for horseshoe fistula 62.5% (5a /8) |
Failure after LIFT 16.1% (10/62); median time interval to recurrence was 3 months (1–12) All recurrent fistulas became intersphincteric fistulas |
Cleveland Clinic Florida Fecal Incontinence (CCF-FI) mean score 0 Autonomous control of anal sphincter 100%a (62/62) Note: Not reported if this is pre- or postoperatively |
Not reported |
| Ye 2015 | Modified LIFT, n = 43 (4 patients were lost to follow-up and excluded from analysis; n = 39) |
Healing: complete wound healing in combination with the absence of symptoms Recurrence was not defined Wexner and Fecal Incontinence Severity Index were used to assess fecal incontinence before and at 6 months after the procedure |
Note: 4 patients were lost to follow-up and therefore excluded from analyses. The denominator decreased from 43 to 39 1. Closure rate, at the end of follow-up 87.2% (34/39) 2. Median time to healing 13 days (range 9–21 days) 3. Primary healing rate 71.8% (28/39) 4. Secondary healing rate 15.4% (6/39); they all had breakdown of the tissue seal with raw area and healed by dressing change 5. Healing rate among those 5 patients who received subsequent fistulotomy 100% (5/5) 6. Overall healing rate 100% (39/39) |
Recurrence rate 12.8%a (5/39); all 5 patients presented with an intersphincteric recurrence |
Median (range) Wexner incontinence scale Preoperatively 0 (0–20) Postoperatively 0 (0–20) Other patient-reported fecal incontinence: Fecal incontinence severity index: Preoperative 0 Postoperative 0 |
Not reported |
| Transanal opening of intersphincteric space (TROPIS) | ||||||
| Garg 2017 | n = 61 (9 participants were excluded from analysis; n = 52) |
Healing: all the tracts are healed completely with no pus discharge from any of the tracts or the anus Failure: pus discharge from even a single tract Vaizey incontinence score used to assess fecal incontinence |
Healing rate after 1 surgery 84.6% (44/52) Overall healing rate 90.4% (47/52) after 2 surgeries (3 out of 4 patients who had a reoperation healed completely) |
15.4% (8c/52) did not heal after 1 surgery |
Vaizey Incontinence Score Preoperative incontinence scores 0.19 ± 0.4 Postsurgery after 3 months 0.32 ± 0.6 |
Not reported |
CCF complex cryptoglandular fistula, LIFT ligation of intersphincteric fistula tract, SEM standard error of the mean
aCalculated value
bNumbers for calculation not reported
cMiscalculated as 9 in the paper