A randomized, controlled trial of fibrin glue vs. conventional treatment for anal fistula. Controlled, randomized trial of island flap anoplasty for treatment of trans-sphincteric fistula-in-ano: early results. Repair of fistulas-in-ano using autologous fibrin tissue adhesive. Radiofrequency fistulotomy: a better alternative for treating low anal fistula. Radiosurgical fistulotomy; an alternative to conventional procedure in fistula in ano. Radiofrequency fistulectomy vs. diathermic fistulotomy for submucosal fistulas: a randomized trial. Randomized clinical trial comparing simple drainage of anorectal abscess with and without fistula track treatment. Randomized controlled trial of primary fistulotomy with drainage alone for perianal abscesses. Efficacy of fibrin sealant in the management of complex anal fistula: a prospective trial. Repair of chronic anorectal fistulae using commercial fibrin sealant. Preliminary results of using a commercial fibrin sealant in the treatment of fistula-in-ano. A randomized trial of fistulotomy in perianal abscess. Prospective randomized trial of drainage alone vs. drainage and fistulotomy for acute perianal abscesses with proven internal opening. Prospective randomised trial comparing ayurvedic cutting seton and fistulotomy for low fistula-in-ano.
Fibrin glue is a novel treatment for anal fistulas and possesses many advantages in the treatment of difficult high fistulas. Fibrin glue treatment is simple and repeatable; failure does not compromise further treatment options; and sphincter function is preserved. We aimed to compare the outcomes of patients with low and high anal fistulas randomly assigned to either fibrin glue or conventional treatment.
                Patients with simple fistulas (low fistulas) and complex fistulas (high, Crohn's, and low fistulas with compromised sphincters) were randomly assigned to either fibrin glue or conventional treatment (fistulotomy or loose seton insertion with or without subsequent advancement flap). Patients with rectovaginal fistulas and anal fistulas associated with chronic cavities, acute sepsis, and side branches were excluded. The primary end point was fistula healing. Secondary end points were complications, changes in preoperative continence score, changes in maximum resting and squeeze pressure, satisfaction scores, and pain scores and time off work (simple fistulas only).
                Patients in the fibrin glue and conventional treatment arms were well matched for gender, median age, duration of fistula symptoms, and follow-up. Fibrin glue healed three (50 percent) of six and fistulotomy seven (100 percent) of seven simple fistulas (difference, 50 percent; confidence interval, 10 to 90 percent; P= 0.06, Fisher's exact probability test). There was no change in baseline incontinence score, maximum resting pressures, or squeeze pressures between the study arms. Return to work was quicker in the glue arm, but pain scores were similar and satisfaction scores higher in the fistulotomy group. Fibrin glue healed 9 (69 percent) of 13 and conventional treatment 2 (13 percent) of 16 complex fistulas (difference, 56 percent; 95 percent confidence interval, 25.9 to 86.1 percent; P= 0.003, Fisher's exact probability test). There was no change in baseline incontinence score, maximum resting pressures, or squeeze pressures in either study arm. Satisfaction scores were higher in the fibrin glue group.
                No advantage was found for fibrin glue over fistulotomy for simple fistulas, but fibrin glue healed more complex fistulas than conventional treatment and with higher patient satisfaction. Treatment of trans-sphincteric fistula is usually a compromise between recurrence and incontinence. Dermal island flap anoplasty has been found to be useful in the treatment of these fistulas. We performed a randomized trial to compare dermal island flap anoplasty with conventional treatment for trans-sphincteric fistula-in-ano. Seventy nine patients with fistula-in-ano were recruited; twenty patients with trans-sphincteric fistula confirmed by endoanal ultrasound were prospectively randomized to receive either dermal island flap anoplasty (IFA) or conventional treatment (CVN) for trans-sphincteric fistula-inano. Conventional treatment consisted of lay open fistulotomy or seton insertion if deemed unsuitable for fistulotomy. Dermal island flap anoplasty involved a cutaneous advancement flap into the rectum. Pain scores, fecal incontinence scores, operative complications, wound healing and recurrence rates were charted. Two patients in the CVN group required seton insertions, which were still intact at the 9-month follow-up. Two patients with similar high trans-sphincteric fistula in the IFA group avoided having a long-term seton. There were no differences in the postoperative pain score, incontinence score, complications, wound healing and recurrence rates between the two groups. IFA is a safe and useful method for treating transsphincteric fistula. It can be considered when a suprasphincteric extension is suspected, thus avoiding risk of incontinence or the discomfort of a long-term seton. Our goal was to determine if autologous fibrin tissue adhesive derived from the precipitation of fibrinogen using a combination of ethanol and freezing, could be used to completely close both simple and complex fistulas-in-ano.
                A 26-patient pilot study was performed in which 100 ml of a patient's blood was drawn 90 minutes before surgery. Autologous fibrin tissue adhesive was prepared. In the operating room the patient underwent an examination under anesthesia, and the primary and secondary fistula tract openings were attempted to be identified. The fistula tract was curetted, and autologous fibrin tissue adhesive was injected into the secondary fistula tract opening until fibrin glue was seen coming from the primary opening. A petroleum jelly gauze was then applied over the secondary opening, and the patient was sent home. Follow-up visits were scheduled for one week, one month, three months, and one year later.
                Twenty-six patients received autologous fibrin tissue adhesive fistula injections, with a mean follow-up of 3.5 months. Initial results were encouraging. Twenty-one of 26 patients (81 percent) had successful initial closure of their fistulas. Two of five failures were injected a second time, and one closed, giving an overall successful closure rate of 85 percent (22/26 patients). Of five patients who failed, mean time to failure was 3.8 weeks. In addition, there was no evidence of infection or complications related to the procedure.
                Our initial results are optimistic and require further support through longer follow-up data. Fibrin glue treatment of anorectal fistulas offers a unique mode of management that is safe, simple, and easy for the surgeon to perform. By using autologous fibrin tissue adhesive the patient avoids the risk of anal incontinence and the discomfort of prolonged wound healing which may be associated with fistulotomy. Wide varieties of approaches are employed in dealing with low anal fistula. However, the simple method of laying open the fistula tract (fistulotomy) is still considered to be the favored one.
                A modified approach to the procedure of fistulotomy is discussed. This study describes the procedure, which used a technique of radiofrequency surgery, and its outcome in 232 patients with low anal fistula. The patients were followed for a period of 15 months.
                The patients were discharged on the same day as the procedure. The mean period off work was four days. The average healing time recorded was 67 days. Four wound complications in the form of premature closure of the external wound were noted, which required trimming of the edges. Two of these wounds remained unhealed. The recurrence rate was 1.7%.
                In this era when the emphasis is on criteria like the minimization of hospital stay, reduction of postoperative pain, early resumption of work and low and comparable recurrence rates, there is a future for the procedure of radiofrequency fistulotomy. Most surgeons continue to prefer the classic lay open technique [fistulotomy] as the gold standard of treatment in anal fistula. In this randomized study, a comparison is made between conventional fistulotomy and fistulotomy performed by a radio frequency device.
                One hundred patients of low anal fistula posted for fistulotomy were randomized prospectively to either a conventional or radio frequency technique. Parameters measured included time taken for the procedure, amount of blood loss, postoperative pain, return to work, and recurrence rate.
                The patient demographic was comparable in 2 groups. The radio frequency fistulotomy was quicker as compared to a conventional one [22 versus 37 minutes, p = 0.001], amount of bleeding was significantly less [47 ml versus 134 ml, p = 0.002], and hospital stay was less when patient was operated by radio frequency method [37 hours versus 56 hours in conventional method, p = 0.001]. The postoperative pain in the first 24 hours was more in conventional group [2 to 5 versus 0 to 3 on visual analogue scale]. The patients from radio frequency group resumed their duties early with a reduced healing period of the wounds [47 versus 64 days, p = 0.01]. The recurrence or failure rates were comparable in the radio frequency and conventional groups [2% versus 6%].
                Fistulotomy procedure using a radio frequency technique has significant advantages over a conventional procedure with regard to operation time, blood loss, return to normal activity, and healing time of the wound. Anal fistula represents one of the most frequent anorectal disease. Fistulotomy is considered the gold standard treatment but related problems are numerous (postoperative pain, bleeding, delayed or impaired wound healing). Fistulectomy lowers the recurrences but is less feasible with longer operating time and healing process. We applied the radiofrequencies to fistulectomy and compared the early and late results with those obtained from traditional fistulotomy.
                Twenty patients were randomized to undergo radiofrequency fistulectomy (10 patients, Group A) or conventional fistulotomy (10 patients, Group B). We analysed the first postoperative day pain, intra- and postoperatory bleeding, operating time, complications (impaired or delayed wound healing, fecal incontinence) and any recurrences.
                The mean values for operative time have been 18.3 min for group A (range 15-26 min) and 17.9 min for group B (range 13-21 min). According to VAS scale, first postoperative day pain mean values were 2.8 for group A (range 2-4) and 4.1 for group B (range 3-5). Intra- and post-operative bleeding has always been negligible and faecal incontinence was never observed. Healing time mean values have been 3.5 weeks for group A (range 3-5) and 5.9 weeks for group B (range 4-8 weeks). Long-term results did not evidence complications or recurrences for both groups.
                The application of radiofrequencies to fistulectomy renders more feasible and easies the operation. Postoperative pain is smaller than traditional fistulotomy because of the lower temperatures used and for the shorter time spent in coagulating. This gives a faster wound healing. In conclusion we think that radiofrequency fistulectomy is technically more advantageous than traditional fistulotomy and furnishes better results. Anal abscess is a frequent acute proctological disorder and whether the underlying fistula should be treated at the same time when the abscess is drained remains controversial. We examined indications for drainage alone versus drainage plus fistulotomy in terms of recurrence and continence.
                We carried out a randomized prospective study of 200 consecutive patients with anal abscess. One group received drainage alone, while in the other group drainage plus fistulotomy was performed when a subcutaneous-mucosa, low transsphincteral, or intersphincteral fistula was found. Delayed progressive fistulotomy with suture threads was performed in cases of high transsphincteric or suprasphincteric fistula.
                The internal opening of the fistula track was found in 83% of the patients. The recurrence rate was related to the surgical technique employed: 29% in the group with drainage alone and 5% in the group for which treatment of the fistula track was attempted. The incontinence rate was also related to the surgical option. In those receiving drainage and treatment of the fistula track incontinence was restricted mostly to patients with delayed fistulotomy (36.7%), compared to 2.8% of patients when simple fistulotomy was performed. There was no incontinence in the drainage alone group.
                Drainage of anal abscess with fistulotomy can be safely performed in cases of subcutaneous, intersphincteral, or low transsphincteral fistulae with a minimal recurrence rate. However, drainage alone and posterior treatment of the fistula track is recommended for high transsphincteral or suprasphincteral fistulae. Primary fistulotomy may be advantageous for perianal abscesses because unlike ischiorectal abscesses, fistulas are more commonly found and can be laid open with full preservation of the external anal sphincters. Therefore, a randomized, controlled trial was conducted to compare primary fistulotomy with incision and drainage alone, specifically for perianal abscesses.
                Fifty-two consecutive patients (43 males; mean age, 40 (standard error of mean, 2) years) with perianal abscesses were randomized to treatment by either incision and drainage (controls; N = 28) or fistulotomy (N = 24). Patients were followed up clinically for a mean of 15.5 (standard error of the mean, 0.7) months. Anorectal manometry was also performed before, six weeks, and three months after surgery.
                Persistent fistulas developing after surgery were significantly more common after incision and drainage (N = 7; 25 percent) than after fistulotomy (N = 0; P = 0.009). One patient in each group was also found to have a residual abscess, which required repeat drainage. All patients remained fully continent. The anal pressures after incision and drainage and fistulotomy were not significantly different. Operative time, hospital stay, and time for the wound to heal completely were the same in both groups.
                Primary fistulotomy at the time of drainage for perianal abscesses results in fewer persistent fistulas and no added risk of fecal incontinence. A prospective trial was conducted to establish long-term healing of complex idiopathic anorectal fistula, without extension, after fibrin glue treatment, with clinical assessment and magnetic resonance imaging to determine tract healing.
                Twenty-two patients undergoing glue instillation after fistula curettage and irrigation were followed up for a median of 14 months. Clinical assessment, short tau inversion recovery sequence magnetic resonance imaging, and combined short tau inversion recovery and dynamic contrast-enhanced magnetic resonance imaging were performed at a median of three months postoperatively, and their ability to predict outcome in the presence of early skin healing was determined.
                Of 22 patients, 19 (86.5 percent) had transsphincteric fistulas, 1 (4.5 percent) had a suprasphincteric fistula, 1 (4.5 percent) had an extrasphincteric fistula, and 1 (4.5 percent) had a rectovaginal fistula. None had clinical or radiologic evidence of secondary extension. Despite skin healing in 17 (77 percent) of 22 patients at a median of 14 days after treatment, only 3 (14 percent) remained healed at 16 months. Magnetic resonance imaging with short tau inversion recovery sequences in combination with dynamic contrast-enhanced magnetic resonance imaging predicted outcome in all 10 assessments (100 percent), compared with short tau inversion recovery sequence alone in 16 (94 percent) of 17 assessments or clinical examination in 12 (71 percent) of 17 (P = 0.02).
                The success rate of fibrin glue application for complex anorectal fistulas without extension is 14 percent. Magnetic resonance imaging predicts outcome at an earlier stage than clinical examination. Commercially produced fibrin sealant can be used to completely close both simple and complex fistulae in ano.
                A 29-patient prospective nonrandomized clinical trial was performed. In the operating room, the patient underwent an examination with anesthesia and the primary and secondary fistula tract openings were attempted to be identified. The fistula tract was curetted and fibrin sealant was injected into the secondary fistula tract opening until fibrin sealant was seen coming from the primary opening. A petroleum jelly gauze was then applied over the secondary opening and the patient was sent home. Follow-up visits were scheduled for 1 week, 1 month, 3 months, and 1 year later.
                Twenty-nine consecutive patients received fibrin sealant injections for their fistulae in ano, with a mean follow-up of 6 months. Two patients had a history of Crohn disease (regional enteritis) and 2 patients had human immunodeficiency virus infection. Overall, 17 (68%) of 25 patients have had successful closure of their fistula with 4 patients lost to follow-up. Two patients required reinjection with fibrin sealant, and neither of these subsequently had closure. One of the 2 patients with Crohn disease had closure, as well as 1 human immunodeficiency virus-positive patient. In addition, there has been no evidence of incontinence or complications related to the use of fibrin sealant in this procedure.
                Initial results in the treatment of chronic anorectal fistulae using commercial fibrin sealant are optimistic, but require further support through longer follow-up data. Fibrin sealant treatment of anorectal fistulae offers a unique mode of management which is safe, simple, and easy for the surgeon to perform. By using fibrin sealant, the patient avoids the risk of fecal incontinence and the discomfort of prolonged wound healing that may be associated with fistulotomy. A prospective non-randomised study fibrin sealant injection to manage patients with fistula-in-ano, with magnetic resonance imaging (MRI) monitoring, was performed during the period 5/6/1999 to 28/2/2000. The aim was to determine whether a fibrin sealant could be used as a treatment modality for anorectal fistula and the usefulness of MRI perineum to monitor the disease activity. Ten patients were included in the study. Mean age was 47 years (range 7 months to 70 years). Male: female ratio was 9:1. Mean follow-up duration was 26.4 weeks. The overall success rate was 60%. The success rate of different fistula types were different (60%, 0%, 100% for intersphincteric, transphincteric, subcutaneous, respectively). Variable decrease in signal on STIR images and contrast enhancement was noted in the patients with successful and failure of fibrin sealant injection. In conclusion, fibrin sealant injection is a useful alternative treatment in the management of fistula-in-ano. MRI is helpful in delineating the anatomy of fistula-in-ano but not a useful tool to follow-up disease activity. In a randomized trial we compared the treatment of perianal abscess by incision only (18 patients) with that by incision followed by fistulotomy 3 days later (20 patients). All patients were observed for 12 months. There were no differences between the two groups with regard to recurrent abscess/fistula, but the fistulotomy group had a statistically significantly higher prevalence of flatus incontinence. Further, fistulotomy was followed by significantly longer duration of hospitalization and by delayed healing. We recommend that fistulotomy is used only in patients with recurrent abscess. Incision and drainage (I & D) with concurrent or delayed fistulotomy is the usual treatment for abscess-fistula with a demonstrated internal opening. We compared incision and drainage alone vs. with concurrent fistulotomy for perianal abscesses with a demonstrated internal opening.
                Consecutive patients with acute perianal abscesses and a demonstrated internal opening were prospectively randomized into either the I & D group or drainage with concurrent fistulotomy group. They were followed up at one month, three months, and one year.
                The I & D group had 21 patients, and the fistulotomy group had 24 patients. Thirteen patients had low intersphincteric abscess-fistula, and seven had low transsphincteric fistulas in the I & D group. The fistulotomy group had 9 intersphincteric abscess-fistula compared with 14 low transsphincteric ones. Median duration of surgery, hospital stay, and continence at final follow-up were the same in the two groups. Three had recurrent abscess-fistula in the I & D group compared with none in the fistulotomy group (P = 0.09).
                I & D alone for acute anal abscess-fistula with demonstrated internal opening showed a tendency to recurrence that did not reach a statistically significant difference compared with concurrent fistulotomy. I & D, therefore, puts only a few patients at risk for recurrence. The aim of this study was to evaluate the role of ayurvedic setons in the treatment of low fistula-in-ano. One hundred and eight patients were randomised into either conventional fistulotomy (F) or ayurvedic cutting seton insertion (C). Endpoints investigated included time to wound healing and complications of surgery. Post-operative pain scores were measured daily using a visual analog scale. Anal function was compared using a continence score. Pre- and postoperative manometry and ultrasound were also performed. After exclusions, there were 54 patients in group F and 46 in group C. There were no differences in age, sex or follow-up duration between the two groups. Healing time was similar between the groups. Group C reported more pain following operation and on the first 2-4 postoperative days, but both groups experienced the same amount of pain subsequently. In conclusion, chemical seton was more painful than conventional fistulotomy in the first few days following surgery. However, there was no difference in time to wound healing, complications or functional outcome.
There are very few randomized controlled trials comparing the various modalities of surgery for fistula in ano. While post operative pain, time to healing and discharge from hospital affect quality of life, recurrence and incontinence are the most important. As it turns out, there seems to be no major difference between the various techniques used as far as recurrence rates are concerned.
The use of Fibrin glue and advancement flaps are associated with low incontinence rates. 
There is a crying need for well powered, well conducted randomised controlled trials comparing various modes of treatment of fistula in ano. Newer operations like the anal fistula plug and the LIFT procedure need to be evaluated by randomised clinical trials.