Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.

OBJECTIVES: Many fecal incontinence (FI) studies define primary efficacy outcome as a decrease from baseline of ≥50% in the number of FI episodes; this threshold has never been validated. We aimed to establish the validity and responsiveness of ≥50% reduction in FI episodes (responder50) as the threshold indicative of clinically meaningful response. METHODS: Adults with a Cleveland Clinic Florida fecal incontinence score ≥10 were randomized to receive nonanimal stabilized hyaluronic acid/dextranomer (NASHA/Dx) injection or sham treatment in a 6-month trial. Validity and responsiveness of the primary end point were evaluated post hoc. The data were compared using different thresholds for defining a responder for a number of end points. RESULTS: Data from 206 patients (NASHA/Dx, n=136; sham, n=70) were evaluated. Incremental patient response threshold increases showed that although the percentage of patients who achieved response decreased with increasing threshold, the difference between treatments remained significant up to an 80% response threshold (NASHA/Dx, 23%; sham, 10%; P=0.02). Response thresholds between 40% and 80% demonstrated evidence for convergent validity, with the strongest correlation with the number of FI episodes, the number of FI episodes when the patient was awake, and the number of FI-free days observed at ≥40% and ≥50% thresholds. Further examination of the responder50 threshold indicated that, regardless of treatment (NASHA/Dx or sham), responders performed significantly better than nonresponders on nearly all secondary efficacy end points. CONCLUSION: This study demonstrates the responsiveness, validity, and clinical applicability of the ≥50% response threshold in clinical studies of patients with FI receiving treatment with NASHA/Dx.

Efficient vessel feature detection for endoscopic image analysis.

Distinctive feature detection is an essential task in computer-assisted minimally invasive surgery (MIS). For special conditions in an MIS imaging environment, such as specular reflections and texture homogeneous areas, the feature points extracted by general feature point detectors are less distinctive and repeatable in MIS images. We observe that abundant blood vessels are available on tissue surfaces and can be extracted as a new set of image features. In this paper, two types of blood vessel features are proposed for endoscopic images: branching points and branching segments. Two novel methods, ridgeness-based circle test and ridgeness-based branching segment detection are presented to extract branching points and branching segments, respectively. Extensive in vivo experiments were conducted to evaluate the performance of the proposed methods and compare them with the state-of-the-art methods. The numerical results verify that, in MIS images, the blood vessel features can produce a large number of points.More importantly, those points are more robust and repeatable than the other types of feature points. In addition, due to the difference in feature types, vessel features can be combined with other general features, which makes them new tools for MIS image analysis. These proposed methods are efficient and the code and datasets are made available to the public.

Silver-based dressings for the reduction of surgical site infection: review of current experience and recommendation for future studies.

Surgical site infections (SSIs) are the most common hospital acquired infection in surgical patients, occurring in approximately 300,000-500,000 patients a year. SSIs occur across all surgical specialties, but have increased importance in abdominal, colorectal, obstetrical, gynecological, cardiac, vascular, neurological, transplant, and orthopedic procedures where either the inherent risk is elevated or the consequence of an infection would be severe. Current prevention guidelines reduce, but do not completely eliminate, the occurrence of SSIs. We have found the use of silver-nylon wound dressings to significantly reduce the risk SSI associated with colorectal surgery. In this review, we examine the incidence of SSI in high-risk groups, and identify procedures where silver dressings, and other silver products, have been evaluated for the prevention of SSI. Silver-nylon dressings are a useful adjunct in the prevention of SSI in colorectal surgery, neurological surgery, spinal surgery, and certain cardiovascular and orthopedic procedures. Gynecologic, obstetric, breast, transplant, neck, and bariatric procedures, and surgery in obese and diabetic patients, represent other areas where patients are at increased risk of SSI, but in which silver dressings have not been adequately evaluated yet. Recommendation is made for large prospective studies of silver dressings in these populations.

Do silver-based wound dressings reduce pain? A prospective study and review of the literature.

Silver-containing dressings are a mainstay in the management of burn injury and acute and chronic wounds. In addition to antimicrobial activity, there is anecdotal evidence that silver dressings may modulate or reduce wound pain. Pain is subjective and difficult to quantify, and most studies of silver-containing dressings evaluate pain as a secondary rather than a primary outcome. Nevertheless, a dressing with a proven ability to reduce pain independent of systemic analgesics would have great utility. In this study, we compared patient-reported pain levels in patients previously randomized to receiving silver-nylon dressings vs. conventional gauze dressings in a study of surgical site infection. Compared to gauze dressings, patients in the silver dressing group reported less pain between postoperative days 0 and 9 (p<0.02). Post hoc analysis of analgesic use did not reach statistical significance between the groups. The study was completed with a literature review of the effect of silver on pain. Silver-based dressings may reduce wound pain by providing an occlusive barrier or by other as-yet undefined mechanisms. The role of silver in pain relief, however, cannot be definitively stated until well-designed prospective randomized studies evaluating pain as a primary endpoint are carried out.

A reproducible ex vivo model for transanal minimally invasive surgery.

BACKGROUND: Rectal tumors can be excised through a number of minimally invasive transanal techniques including transanal excision, transanal endoscopic microsurgery, and transanal minimally invasive surgery (TAMIS). Specialty training is often required to master the nuances of these approaches. This study aimed to create a reproducible transanal excision training model that is suited for laparoendoscopic techniques. METHODS: Frozen porcine rectum and anus with intact perianal skin were commercially obtained. Thawed specimens were then cut to approximately 20 cm in length. The proximal end of the rectum was then everted and suction applied to the mucosa to create pseudopolyps of various sizes (sessile and pedunculated). Larger pedunculated lesions were made by tying the base of the pseudopolyps with 5-0 monofilament sutures to gather more tissue. Methylene blue dye was injected submucosally into the lesions to simulate tattoos. The proximal rectum was then closed with sutures. The model was suspended in a trainer box by clamping the distal end in a ringed clamp and the proximal end to the box. Transanal excisions using TAMIS were then performed. The procedures were done by trained community colorectal surgeons attending courses on transanal minimally invasive surgery. RESULTS: Both partial- and full-thickness excisions of sessile and pedunculated rectal lesions were successfully performed during simulated TAMIS by trained community surgeons learning this laparoendoscopic technique. CONCLUSION: Transanal laparoendoscopic procedures to excise rectal tumors can be successfully and reproducibly performed in an ex vivo porcine anorectal model.

Robot-assisted rectopexy and colpopexy for rectal prolapse.

AIM: This video demonstrates a technique for robot-assisted combined rectopexy with colpopexy, but without the use of mesh for rectal prolapse. METHODS: This case features a 61-year-old woman who presents with complaints of tissue protruding through her rectum and fecal incontinence. On examination, she was found to have circumferential, full-thickness rectal prolapse and perineal descent. We present a technique that combines rectopexy with colpopexy without the use of mesh for repair of rectal prolapse. Postoperative examination revealed resolution of rectal prolapse and good perineal support. This video illustrates a technique that may serve as a useful adjunct to have in one's surgical armamentarium in circumstances when mesh should not or cannot be used, such as in cases that require resection of the sigmoid colon or for patients who simply prefer to avoid the use of mesh. CONCLUSION: Given that rectal prolapse and posthysterecomy vaginal vault prolapse often occur together, our institution routinely performs colpopexy with rectopexy for rectal prolapse to provide additional support to the pelvic floor as demonstrated in this video.

Treatment of refractory perianal fistulas with ligation of the intersphincteric fistula tract: preliminary results.

Several surgical options exist for management of fistula in ano. The goal of treatment is to achieve closure of the fistula while maintaining continence. Sphincter-sparing operations to close perianal fistulas include advancement flap, anal fistula plug, fibrin glue, and fistulectomy. Variable success rates from 30 to 80 per cent have been reported. Ligation of intersphincteric fistula tract (LIFT), first described in 2007, has a reported success rate from 40 to 94 per cent. The objective of this study was to study our results of the LIFT procedure for refractory perianal fistulas. We conducted a retrospective 18-month review of consecutive patients with refractory perianal disease treated with the LIFT procedure at an academic, tertiary, colorectal practice. All patients undergoing a LIFT procedure for anal fistula from August 2010 to August 2012 were included in the study. The primary end points were success rates at 1 month and 3 months. Secondary end points were postoperative complications and maintenance of continence. Twenty patients underwent LIFT procedures of whom nine had previously failed treatments. Mean age was 45 years and included 12 male and eight female patients. Success rate at 1 month was 70 per cent (14 patients) and at 3 months was 80 per cent (16 patients). Success rates for patients with previously failed attempts were 67 per cent at 1 month and 89 per cent at 3 months. Continence was maintained in 100 per cent of patients. Our data support the use of the LIFT procedure for refractory perirectal fistulas.

The use of silver nylon in preventing surgical site infections following colon and rectal surgery.

BACKGROUND: Patients who undergo colorectal surgery have up to a 30% chance of developing a surgical site infection postoperatively. Silverlon is a silver nylon dressing designed to prevent surgical site infections, but only anecdotal evidence has previously supported its efficacy. OBJECTIVE: The aim of this study was to evaluate the effect of silver nylon dressings in patients undergoing colorectal surgery. DESIGN: We performed a prospective, randomized, controlled trial comparing a silver nylon dressing with gauze dressings in patients undergoing elective colorectal surgery. SETTING: The study was performed at a university-based, tertiary referral center. PATIENTS: We studied patients undergoing elective colorectal surgery with an abdominal skin incision of at least 3 cm. INTERVENTION: Patients were randomly assigned to receive either a silver nylon or a gauze dressing. MAIN OUTCOME MEASURES: The primary end point was surgical site infection occurring within 30 days of surgery. RESULTS: One hundred ten patients were enrolled in the study and were randomly assigned to 1 of 2 treatment groups. After a 30-day follow-up period, the incidence of surgical site infection was lower in the silver nylon group compared with the control group (13% vs 33%, P = .011). Twenty-five patients in the study developed superficial surgical site infections, 5 in the silver nylon group and 14 in the control group (P = .021). Two patients in the study group developed deep wound infections compared with 4 in the control group (P = .438). Multivariate analysis revealed that patients in the control group had a 3-fold increase in risk of infection compared with patients in the silver nylon group (P = .013). LIMITATIONS: A limitation of this study is that the members of the surgical team were not blinded to the treatment groups. CONCLUSION: Silver nylon is safe and effective in preventing surgical site infection following colorectal surgery.

Fecal diversion in perirectal fistulizing Crohn's disease is an underutilized and potentially temporary means of successful treatment.

The purpose of this study was to determine the outcome of patients treated with fecal diversion for perirectal fistulizing Crohn's disease. Thirty-nine patients were identified and followed for an average of 60 months. Patients were divided into two groups based on surgical treatment: local surgical treatment only and fecal diversion in addition to local surgical therapy. Thirteen patients (33%) underwent fecal diversion due to the severity of their disease. Eleven of these patients (85%) had complete resolution of their fistulas and only two (15%) required proctectomy. In contrast, only five out of 26 patients (19%) who underwent local surgical procedures alone had complete perirectal disease resolution. Intestinal continuity was restored in six patients (46%) and three of these patients (50%) remained disease free. The remaining three patients had disease recurrence, which required additional local procedures in one patient (17%), but with eventual resolution; the other two patients (33%) necessitated rediversion. Our data suggest that fecal diversion is a viable treatment option for severe perirectal fistulizing Crohn's disease and may be associated with a higher rate of resolution than local surgical treatment alone. In addition, we demonstrate a higher rate of successful intestinal continuity restoration than is typically reported.

Laparoscopic-assisted transvaginal approach for sigmoidectomy and rectocolpopexy.

BACKGROUND AND OBJECTIVES: Laparoscopic-assisted colonic resection has been well described for multiple surgical indications. This typically requires an abdominal incision for specimen removal that is associated with the majority of postoperative pain. We describe the first laparoscopic-assisted transvaginal approach for sigmoidectomy and rectocolpopexy for the treatment of rectal prolapse. METHODS: Mobilization of the sigmoid colon was performed laparoscopically using a 12-mm vaginal port and 3 additional 5-mm abdominal ports. A laparoscopic stapler was used through the vaginal port to transect the distal sigmoid colon. The specimen was subsequently externalized through the colpotomy to complete the resection and prepare the remaining bowel for intracorporeal, end-to-end, stapled anastomosis. The colpotomy was then repaired, and the colorectal anastomosis and rectocolpopexy were completed laparoscopically. RESULTS: Sigmoidectomy and rectocolpopexy were successfully performed laparoscopically by using a transvaginal approach without the need for an abdominal incision for specimen removal. The patient had an uncomplicated postoperative course, complained of minimal pain, and was discharged home on postoperative day 3. CONCLUSIONS: Laparoscopic-assisted transvaginal sigmoidectomy and rectocolpopexy is a feasible option that appears to be associated with little incisional pain and rapid recovery.