A comparative study between high ligation of the inter-sphincteric fistula tract via lateral Approach Versus Fistulotomy and primary sphincteroplasty in High Trans-Sphincteric Fistula-in-Ano: a randomized clinical trial

Abstract Background Trans-sphincteric fistula management is very challenging and everyday new techniques are introduced to reach the safest and the most effective technique. In this study two of the most effective techniques are compared based on their post-operative outcomes. Objective To compare the efficacy of high ligation of the inter-sphincteric fistula tract by lateral approach (modified LIFT) and Fistulotomy and primary sphincteroplasty (FIPS) in the management of high trans-sphincteric fistula regarding their post-operative outcomes in the form of post-operative pain, time of wound healing in weeks, wound infection, incontinence and recurrence within one year. Patients and methods : The current study is single-blind, prospective, randomized, controlled, single-center trial conducted from June 2020 to June 2022 in the colorectal surgical unit of Ain Shams University Hospitals, which included 80 patients presented with high trans-sphincteric perianal fistula 55 (68.75%) males and 25 (31.25%) including a one-year follow-up postoperative. Results There were 80 patients in our study 40 patients in each group. The mean age of group (I) is 46.65 with standard deviation 6.6. while, in group (II) the mean age is 45.85 with standard deviation 6.07 (p = 0.576). From the included 80 patients 55(68.7%) were males and 25 (31.25%) were females (p = 0.469). Regarding, postoperative wound infection occurred in 2(5%) Patients in group (I) and 7(17.5%) patients in group (II) (p = 0.154). There were no cases of incontinence in group I. However, there were 6(15%) cases of incontinence to gases only scored by Wexner score 3/20 in group II (p = 0.026) and its significant difference between the two techniques. Postoperative pain was assessed for one week duration by the visual analogue score (VAS) from 0 to 10 in which, zero is the least and 10 is the maximum. In group (I) 18(45%) patients scored their pain mild from 1 to 3, 20(50%) patients scored their pain moderate from 4 to 6 and 2(5%) patients scored severe pain from 7 to 9. While, in group (II) 14(35%) patients scored their pain mild from 1 to 3, 22(55%) patients their pain moderate from 4 to 6 and 4(10%) patients scored their pain severe from 7 to 9 (p = 0.275). Recurrence in one-year follow-up occurred in 13(32.5%) patients in group (I) about 7 patients had recurrence in the form of inter-sphincteric fistula and 6 patients in the form of trans-sphincteric fistula. While, in group II recurrence occurred in 1 (2.5%) patient in the form of subcutaneous fistula at the healing site (p = 0.001). Conclusion Fistulotomy and primary sphincteroplasty is an effective and preferred technique for the trans-sphincteric fistula repair with high statistically significant lower incidence of recurrence in one-year follow-up as compared to modified LIFT technique. Although, there is higher incidence regarding incontinence to gases only post-operative. This work recommends fistulotomy and primary sphincter reconstruction procedure in high trans-sphincteric perianal fistulas to be more popular, to be implemented as a corner stone procedure along various and classic operations for such cases as it’s easy, feasible.