Short-term outcomes of a novel endoscopic clipping device for closure of the internal opening in 100 anorectal fistulas.

BACKGROUND: One hundred consecutive applications of a new clipping device, the OTSC® Proctology (Ovesco Endoscopy AG), were analyzed to assess its efficacy for the treatment of complex anorectal fistulas. METHODS: In patients with anorectal fistulas, minimally invasive surgery with the OTSC® Proctology system was performed according to a standardized technique: the fistula tract was debrided using a special fistula brush, and the clip was applied on the internal fistula opening. In some of the patients, postoperative pain was evaluated using a visual analog scale. After 6 months, the postoperative clinical course and the fistula healing were assessed. RESULTS: A total of 100 OTSC® Proctology procedures were performed in 96 patients with 55 transsphincteric, 38 suprasphincteric, 2 extrasphincteric, and 5 rectovaginal fistulas. In all but 11 fistulas (8 Crohn's disease, 3 ulcerative colitis), the fistulas were of cryptoglandular origin. The median operation time was 32 min (range 17-66 min). There were no major intraoperative technical problems. All patients found the postoperative pain to be tolerable with standard pain medication. The short-term results of 99 clip applications were analyzed: the healing rate for first-line fistula therapy was 79 %, whereas in recurrent fistulas, the success rate was 26 %. OTSC® Proctology was successful in 45 % of fistulas associated with inflammatory bowel disease and in 20 % of rectovaginal fistulas. CONCLUSIONS: OTSC® Proctology provides convincing results as first-line treatment for complex cryptoglandular fistulas. It is a safe, effective, minimally invasive, and sphincter-sparing procedure with postoperative pain comparable to other types of fistula surgery.

Prospective pilot study of anorectal fistula closure with the OTSC Proctology.

AIM: The OTSC Proctology is a surgical device for anorectal fistula closure. It consists of a super-elastic nitinol clip, which is placed (with the aid of a transanal applicator) on the internal fistula opening to achieve healing of the fistula track. A prospective, two-centre clinical pilot study was undertaken to assess the efficacy and safety of the OTSC Proctology in patients with a complex high anorectal fistula. METHOD: In patients with a complex anorectal fistula the primary track was debrided using a special brush and the clip was applied to the internal fistula opening. After 6 months the postoperative clinical course and fistula healing were assessed. RESULTS: Twenty patients with a cryptoglandular anorectal fistula (14 with a transsphincteric fistula and six with a suprasphincteric fistula) were included in the study. There were no intra-operative technical or surgical complications. Postoperatively no patient reported intolerable discomfort or a sensation of a foreign body in the anal region. At 6 months after surgery, 18 (90%) patients had no clinical signs or symptoms of fistula and were considered healed, whereas in two the fistula persisted. In 13 (72%) of these 18 patients, the clip was still in place without causing problems, whereas in three patients the clip had spontaneously detached. In the two remaining patients it was necessary to remove the clip due to discomfort and delayed wound healing. CONCLUSION: Anorectal fistula closure with the OTSC Proctology is an innovative, sphincter-preserving minimally invasive procedure with promising initial results and a high rate of patient satisfaction.

The anal fistula claw: the OTSC clip for anal fistula closure.

AIM: Surgical closure of high or complex anal fistulae is often a difficult challenge. A special Nitinol clip, the OTSC clip (Ovesco AG), was evaluated for fistula closure in a porcine model. METHOD: A total of 20 fistulae were created in 10 animals by seton insertion. Four weeks after fistula induction the setons were removed: one internal fistula opening per animal was left untreated as control whereas the other opening was closed by the OTSC clip using a specially developed transanal clip applicator. The safety and technical feasibility of the clip application were tested. Another 4 weeks later, fistulae were macroscopically assessed for closure. For histological examination, the anorectum including the fistula tract was excised en bloc. RESULTS: Four weeks after clip placement, all external and internal fistula openings were macroscopically closed. The clip application site presented with an increased scarring. Microscopically, 40% of residual tracts and a more intense chronic inflammation were seen in the untreated control fistulae. After clip placement, 10% of the fistulae persisted associated with a higher density of collagen fibres indicating a better fistula scarring and healing. No unexpected side-effects or complications caused by the clip were observed. CONCLUSION: Fistula closure using the OTSC clip represents a promising sphincter-preserving minimally invasive procedure. This study demonstrated the safety and feasibility of the 'anal fistula claw' for fistula closure. In spite of limitations of the porcine model the results justify clinical applications and further investigations.

[Rare complication after STARR operation]. / Seltene Komplikation nach STARR-Operation.

Longo's STARR operation is a new surgical technique for the management of obstructive defecation syndrome. A major advantage is the repair of rectocele and intussusception in a single transanal approach. Complications such as bleeding, infection, anal stenosis, and fistulas are known. In the described patient we detected a cavity in the spatium rectovaginale which was lined by rectum mucosa and connected to the rectum as a result of an incomplete resection of rectum wall and dilatation of the stapler suture. Recurrent stool incrustration in the cavity led to preformation of coproliths. We performed a modified Rehn-Delorme operation to resect the cavity. The STARR operation is a technique which should be used carefully and performed only by surgeons with experience and full knowledge of the potential complications.

Enteral vs parenteral nutrition in reconstructive anal surgery--a prospective-randomized trial.

OBJECTIVE: Early defecation after reconstructive anal surgery may influence the outcome negatively. Different methods are used to avoid bowel movements in the early postoperative period. We questioned whether stool behaviour is influenced by total parenteral nutrition as opposed to enteral nutrition with resorbable sip feeds. Furthermore, satisfaction of patients with each nutrition regime, cost differences and influence of the postoperative outcome were evaluated. METHOD: Between January and October 2004, 32 patients were evaluated in a prospective randomized, surgeon-blinded trial. The parenteral group (PG, n = 16) received 1250 ml Nutriflex lipid basal (B. Braun Comp., Melsungen, Germany) intravenously. The enteral group (EG, n = 16) was offered a total amount of three cups of Clinutren fruit (Nestle Nutrition GmbH, Frankfurt, Germany), two boxes of OPD (oligopeptide diet) Elemental 028 extra (SHS, Liverpool, UK) and two cups of OPD Peptamen (Nestle Nutrition GmbH). Both groups received 1000 ml of isotonic cristalloid solution and were allowed to drink up to 1000 ml of tea or water per 24 h. RESULTS: The satisfaction of patients was significantly higher in the EG. In regard to stool behaviour both groups showed no differences, in the number of bowel movements or in the time to the first postoperative defecation. Enteral feeding resulted in a minimum saving of 220 euros. Postoperative results in the case of plastic fistula closure did not differ between both groups. CONCLUSIONS: Sufficient bowel confinement during the early postoperative period after anal reconstructive surgery may be achieved by using resorbable sip feeds rather than parenteral nutrition.

[Perianal and rectal impalement injuries]. / Pfählungsverletzungen des Anus und des Rektums.

Perianal impalement injuries with or without involvement of the anorectum are rare. Apart from a high variety of injury patterns, there is a multiplicity of diagnostic and therapeutic options. Causes of perianal impalement injury are gunshot, accidents, and medical treatment. The diagnostic work-up includes digital rectal examination followed by rectoscopy and flexible endoscopy under anaesthesia. We propose a new classification for primary extraperitoneal perianal impalement injuries in four stages in which the extension of sphincter and/or rectum injury is of crucial importance. Therapeutic aspects such as wound treatment, enterostomy, drains, and antibiotic treatment are discussed. The proposed classification encompasses recommendations for stage-adapted management and prognosis of these rare injuries.