Achieving stomal continence with an ileal pouch and a percutaneous implant.

In this study, a soft-tissue-anchored, percutaneous port used as a mechanical continence-preserving valve in reservoir ileo- and urostomies was functionally and morphologically evaluated in eight dogs. During follow-up, the skin failed to attach to the implant, but the intestine inside the stoma port appeared to be attached to the mesh. After reaching adequate reservoir volume, the urostomies were rendered continent by attaching a lid to the implant. The experiments were ended at different time intervals due to implant-related adverse events. In only one case did the histological evaluation reveal integration at both the implant-intestine and implant-skin interfaces, with a low degree of inflammation and the absence of bacterial colonisation. In the remaining cases, integration was not obtained and instead mucosal downgrowth and biofilm formation were observed. The skin-implant junction was characterised by the absence of direct contact between the epidermis and the implant. Varying degrees of epidermal downgrowth, granulation tissue formation, inflammatory cell infiltration and bacterial growth and biofilm formation were prominent findings. In contrast, the subcutaneously located anchor part of the titanium port was well integrated and encapsulated by fibrous tissue. These results demonstrate the opportunity to achieve integration between a soft-tissue-anchored titanium port, skin and intestine. However, predictable long-term function could not be achieved in these animal models due to implant- and non-implant-related adverse events. Unless barriers at both the implant-skin and implant-intestine junctions are created, epidermal and mucosal downward migration and biofilm formation will jeopardise implant performance.

Comparison of the clinical outcomes of skin bridge loop ileostomy and traditional loop ileostomy in patients with low rectal cancer.

To compare the clinical results of patients with low rectal cancer who underwent skin bridge loop ileostomy and traditional loop ileostomy, and provide clinical evidence for choosing a better ostomy method. We retrospectively collected data of 118 patients with rectal cancer who underwent low anterior resection and loop ileostomy. To investigate the patients characteristics, postoperative stoma-related complications and the frequency of exchanged ostomy bags. The differences of these indicators between the two groups of patients who underwent skin bridge loop ileostomy and traditional loop ileostomy were compared. The Visual Analog Scale (VAS) score of the skin bridge loop ileostomy group was lower than that of the traditional ileostomy loop group (P < 0.05). The skin bridge group had a lower Discoloration, Erosion, Tissue overgrowth (DET) score and incidence of mucocutaneous separation than the traditional group at the 1st and 2nd weeks after operation (P < 0.05). The average number of weekly exchanged ostomy bags was significantly less in the skin bridge group than in the traditional group within 4 weeks after surgery (P < 0.05). Our experience demonstrates that the skin bridge loop ileostomy may significantly reduce early postoperative stoma-related complications, the frequency of exchanged ostomy bags and patients' medical costs after discharge.

Evaluation of a Novel Ostomy Barrier Ring with Assisted Flow for Individuals with an Ileostomy.

OBJECTIVE: To determine the performance and user experience of a novel ostomy barrier ring over a 4-week period. METHODS: This single-arm investigation conducted across three clinical sites included 25 adult participants with an ileostomy for 3 months or longer. The participants used their standard ostomy pouching appliance along with a novel barrier ring for a period of 4 weeks. Skin condition was assessed using the Ostomy Skin Tool. Change in skin condition over the study period was recorded for each participant. The participants' experience in using the novel barrier ring was measured using a five-point Likert-type scale. RESULTS: Twenty of the 25 participants (80%) completed the trial. Of those participants, the median Ostomy Skin Tool score at both the beginning (range, 0-8) and end was 0 (range, 0-6). In terms of skin condition, 7 participants experienced an improvement in skin condition, 11 experienced no change, and 2 got worse. A median score of 5 out of 5 was recorded for all questions relating to user experience. CONCLUSIONS: Although not statistically significant, there was a clear trend toward improvements in peristomal skin condition using the novel barrier ring, even for participants who were already using a barrier ring. User feedback was positive with respect to comfort, device handling, and the perception of the device's ability to protect the skin. Further, most participants who already used a barrier ring indicated that the novel barrier ring would result in a longer wear time.

Outcomes of stapler repair with anastomosis for stoma prolapse.

PURPOSE: The published data on the outcomes of an operative repair for stoma prolapse are limited. This study aimed to clarify the long-term outcomes of stapler repair with anastomosis for stoma prolapse. METHODS: Twenty-four patients (15 men, median age 64 years, range 33-88 years) undergoing 25 stapler repairs with anastomosis were prospectively registered, and their medical records were retrospectively reviewed. RESULTS: The median length of prolapse was 10 cm (range 5-22). Stoma prolapse repair was performed by means of 16 loop colostomies, four end colostomies, three loop ileostomies, and one end ileostomy. A stapler was used 4.6 times on average (range 4-8). The average operative time and bleeding were 40.8 (range 15-75) min and 40 (range 0-214) mL, respectively. No mortality and morbidity were observed after surgery. A recurrence of stoma prolapse was reported in only one of 25 repairs (4%) at the proximal limb of loop ileostomy during a median follow-up period of 1 year (range 1-120 months). However, a new stoma prolapsed in one untreated limb of loop stoma. CONCLUSIONS: Stapler repair with anastomosis is a safe and minimally invasive treatment option for stoma prolapse with a low recurrence. However, the effectiveness of reparing stoma prolapse on the proximal limb of loop ileostomy might be limited.

Does an Ileostomy Rod Prevent Stoma Retraction? A Meta-analysis of Randomized Controlled Trials.

A rod passed through the mesenteric window is commonly used during maturation of ileostomies, but evidence for the effectiveness of this procedure is limited. PURPOSE: The aim of this meta-analysis was to determine whether ileostomy rods decrease stoma retraction rates in patients undergoing loop ileostomy (LI). METHODS: The PubMed, EMBASE, Cochrane Library, MEDLINE via Ovid, Cumulative Index of Nursing and Allied Health Literature, and Web of Science databases were systematically searched for randomized controlled trials (RCT) published in English from 1990 to the present date using the MeSH terms ostomy, rod, and bridge to compare ileostomies with a rod to those without a rod. Study information, patient demographics, characteristics, and stoma retraction rates were abstracted. The primary endpoint, stoma retraction, was defined as the disappearance of normal stomal protrusion to at, or below, skin level. The Mantel-Haenszel method of meta-analysis with odds ratio and 95% confidence interval (OR [95% CI]) was used. Among-study statistical heterogeneity was assessed using Cochrane chi-squared and I² tests. Tau² analysis to assess between-study variance was employed when I² was greater than 50%. The number needed to treat/harm (NNT) was calculated to assess clinical relevance of any statistical difference. Visual assessment of funnel plots and Egger's test were used to assess for publication bias. RESULTS: Of the 228 publications identified, 3 RCTs totaling 392 patients (194 LI with rod and 198 LI without rod) met the inclusion criteria for analysis. Overall bias risk was low. The stoma retraction rate was 3.1% (6/194) in patients with a rod versus 4.5% (9/198) in patients with LI without a rod at a mean follow-up of 3 months. This difference was not statistically or clinically significant (OR [95% CI] = 0.60 (0.21-1.72); P = .34; NNT = 69), with low statistical heterogeneity noted among the studies (I² = 0%). CONCLUSION: This meta-analysis found that ileostomy rods do not decrease stoma retraction rates at 3-month follow-up. Studies examining the rate of all potential complications in patients who do and do not receive rod placement following IL are needed to help surgeons make evidence-based decisions.

Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients.

BACKGROUND: Defunctioning ostomy is commonly used to protect patients from anastomotic leakage complications after low anterior resection, but is fraught with its own deleterious effects. This first-in-human study examines the safety and preliminary efficacy of Colovac, an anastomosis protection device. The Colovac consists of a flexible bypass sheath, placed in the lumen of colon and anchored above the anastomosis using a vacuum stent. METHODS: 15 patients underwent anterior resection (AR) with anastomosis protection by Colovac at 3 European centers. After 14 days, the anastomosis integrity was examined by CT scan and endoscopy. The device was then endoscopically removed. Data regarding demographics, surgical details, 30 day post-operative complications, and patient satisfaction were collected prospectively. RESULTS: 15 patients (10 male) underwent laparoscopic AR with Colovac placement. Preoperative neoadjuvant therapy was administered to 54% of patients. Device placement was uneventful in all patients with a median duration of 7 min and placement was judged as easy or very easy in 93% of the cases. Patients did not report major discomfort during the 14 days. Endoscopic removal (10 min) was judged as easy or very easy in 87% of the cases. Absence of feces below the Colovac anchoring site was observed in 100% of the cases. 4 anastomotic leakages were observed (including 3 device migrations). Overall 5 patients (33%) required a planned stoma creation. At 3 months, 1 had already been closed. CONCLUSION: Colovac provides a minimally invasive protection of the anastomosis during the healing process by avoiding the need for a diverting ostomy for two-thirds of patients who will not experience anastomotic complications and allowing safe conversion to the standard of care for patients requiring extended anastomotic protection. A larger study is ongoing to confirm these results.

Skin bridge loop stoma: outcome in 45 patients in comparison with stoma made on a plastic rod.

BACKGROUND: Loop stoma reduces the complications related to anastomotic leak. The skin bridge loop stoma is a recently described technique with many potential advantages over the current technique involving a plastic rod. Our experience shows early results (3 weeks after surgery) comparing skin bridge and plastic rod stoma creation. METHODS: In 45 patients operated from January 2016 to December 2018, a loop ileostomy was performed with the skin bridge technique. We compared functional results with a prospective series of 45 patients on which ileostomy was performed on a plastic rod. The report of the routine stoma care visit at 7 and 15 days was compared, as well as the "Stoma quality of life" questionnaire when available. RESULTS: We observed more inflammatory changes of the skin around the stoma in the group with a plastic rod (33 vs 10 patients). The patient-reported evaluation of quality of life showed a better quality of life in skin bridge group. The rate of exchanged stoma wafers was 2.6 vs 5.2 per week in the skin bridge group (p < 0.05). CONCLUSIONS: The skin bridge stoma creation resulted in better early management of the stoma, better adhesion of the stoma appliances, and better quality of life of the patient. As an increased number of stoma appliances are required in the early postoperative period, the economic burden of this treatment is relevant in relation to the major number of medical equipment used in the early period.

Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study.

BACKGROUND: Currently, the only clinically valid method to prevent morbidity and mortality related to colorectal anastomotic leaks is by construction of a protective ileostomy. Intraluminal bypass might also be a possible way to proctect the anastomosis. The aim of the present study was to evaluate the CG-100 intraluminal bypass device for the reduction of anastomosis-related morbidity and stoma creation in cases of rectal resection. METHODS: A prospective study was conducted on patients having sphincter-preserving rectal resection who were treated with the CG-100 device at Soroka University Medical Center, Beer Sheva, Israel between May 2015 and February 2017. The device was implanted during surgery and removed after 10 ± 1 days. All patients underwent a radiologic leak test with water-soluble contrast prior to removal of the device. Patients were followed for 30 days. Information about adverse events, anastomotic leaks, device usability and tolerance were collected. RESULTS: Forty-seven patients participated in the study. Most patients were operated on due to cancer 44 (93.6%). Four (9%) patients received a primary protective stoma on top of the CG-100 device as part of the learning curve of the surgical team and none required a stoma after device removal. Five (9%) serious adverse events were reported, but only 2 (4%) were classified as related to the device. One was a transient enterocutaneous fistula after removal of the device. The second was an asymptomatic radiologic leak in 1 (2.1%) patient which was treated by keeping the device in place and antibiotic treatment for another 10 days without creation of diverting ileostomy. CONCLUSIONS: CG-100 may provide a safe method for fecal diversion over a newly created anastomosis without the complications related to stoma creation and closure. A larger prospective randomized study in patients originally scheduled to receive diverting stoma is needed to confirm these findings.

Endoscopic Magnetic Compression Anastomosis For Small Bowel Bypass in a High Operative Risk Setting.

The endoscopic enteroenteral bypass could revolutionize the treatment of small bowel obstruction (SBO) in inoperable patients. We describe the technique of endoscopic delivery of a magnetic compression anastomosis device and the creation of an enteroenteral anastomosis in a patient with recurrent acute on chronic SBOs and prohibitively high operative risk. In this novel procedure, a magnetic compression anastomosis device is delivered on either side of the obstruction using a hybrid endoscopic/fluorographic technique, effectively bypassing the obstruction and relieving symptoms. The anastomosis was endoscopically evaluated at regular intervals postprocedure. By 7 days, healthy villi were visible through the mated magnetic rings. By 10 days, the anastomosis was widely patent. The rings passed through the ileostomy and were evacuated, and the patient's symptoms completely resolved. The anastomosis remained widely patent at 1 year. In summary, this case demonstrates the benefit of magnetic compression anastomosis in a patient with SBO and high operative risk.

Fat Grafting for Improved Ileostomy Ostomy Device Fit: A Case Report.

For patients with an ostomy, a poor fitting appliance may cause leakage, peristomal dermatitis, and frequent appliance changes. PURPOSE: The purpose of this case study was to report the outcome of fat grafting to augment peristomal soft tissue and improve appliance fit. CASE STUDY: A 57-year-old woman with a history of Crohn's disease presented with soft-tissue deficiency and uneven contour around her ileostomy site. She was unable to properly fit an ostomy appliance, which resulted in leakage, chronic skin irritation, and frequent appliance changes. The patient underwent 2 rounds of fat grafting using fat harvested from her medial thighs and knees infused with dilute lidocaine with epinephrine. The patient noted immediate improvement after 34 cc of processed fat was injected in the first round. Appliance change frequency decreased from daily to every 3 to 4 days. A second graft of 32 cc provided 3 months later further improved appliance fit, reducing appliance change frequency to every 5 to 7 days and obviating the need to use adjustment rings and glue. Pre- and postoperative computed tomography showed increased thickness of abdominal wall subcutaneous tissues. CONCLUSION: Fat grafting around an ostomy site presents a viable option to improve contour and appliance fit with reduced skin irritation and leakage.

Stoma rods in abdominal surgery: a systematic review and metaanalyses.

BACKGROUND: Stoma rods are used traditionally to prevent retraction of loop stomas into the abdominal cavity. However, there is very little evidence to support or refute their use. The aim of the present systematic review and metaanalysis was to assess the current data on stoma rods in loop stomas. The primary outcomes were stoma necrosis and stoma retraction. METHODS: A systematic review and metaanalyses were conducted using the preferred reporting items for systematic reviews and metaanalysis guidelines (PRISMA). The study protocol was registered prospectively on PROSPERO. An electronic search was performed by two reviewers independently using predefined search strategy and Medline. Bibliographies of selected studies were screened for additional references. RevMan was used to generate forest plots and calculate odds ratios and 95% confidence intervals (CIs). RESULTS: In total, five studies were identified that met inclusion criteria, including four randomized controlled trials. Three studies examined only ileostomies, while one included both colostomies and ileostomies, and one only examined colostomies. In total, 561 patients underwent a stoma with a rod compared to 443 without. There was a higher rate of dermatitis (rod 29.86% vs no rod 16% OR 2.65; 95% CI 1.79-3.93) and stoma necrosis (rod 7% vs no rod 1.15% OR 5.58; 95% CI 1.85-16.84) in the rod group, but there was no significant difference in stoma retraction (rod 2.28% vs no rod 3.45%; OR 0.7; 95% CI 0.32-1.54). CONCLUSIONS: Stoma rods do not reduce the incidence of stoma retraction and instead lead to increased rates of dermatitis and stoma necrosis.

Evaluation of a one-piece soft convex ostomy appliance: a prospective, multicentre, open-label pilot study.

Leakage of stomal effluent is considered by people living with a stoma to be the key factor that negatively impacts their quality of life (QoL). This non-randomised pilot study evaluated the performance of a new stoma appliance, Flexima® Active O Convex in 40 ostomy patients with a flat, flush or slightly retracted stoma over a 14-day period. Leakage was reported for the wear time of each pouch by the patients. On 79% of occasions, the patient reported no leakage under the skin protector. The appliance was very well tolerated and the condition of the patients' peristomal skin was maintained throughout the study. The performance was rated as 'good' or 'very good' by most of the patients. The results of this study have shown that the design of this one-piece soft convex appliance can prevent leakage and protect peristomal skin by providing a safe seal around the stoma. It was also reported as being flexible and comfortable to wear.

Changes in Peristomal Skin Condition and User Experience of a Novel Ostomy Barrier Ring With Assisted Flow: A 6-Week Feasibility Study.

PURPOSE: This purpose of this study was to evaluate a novel barrier ring with an assisted flow mechanism by assessing changes in peristomal moisture-associated skin damage (MASD) and perceptions of comfort, security, handling, and discretion in persons with an ileostomy for 6 months or longer. DESIGN: Single-arm, open-labeled feasibility study. SUBJECTS AND SETTINGS: Twenty participants (aged ≥18 years) with an ileostomy for 6 months or more participated in the study and 12 completed data collection. The primary reason for dropouts concerned compatibility issues with the barrier ring when used with certain convex pouching systems. METHODS: Participants used the barrier ring along with their normal ostomy pouching system for a period of 6 weeks. Changes in skin condition were assessed using the Ostomy Skin Tool (OST). Participants' perception of the barrier rings' comfort, security, handling, and discretion were also recorded on a 10-point scale, where participants would offer a low score if their experience was negative and a higher score if their experience was positive. Participants changed pouches and barrier rings at their own discretion. For participants who completed the study, the average skin condition and median ratings of comfort, security, handling, and discretion at 6 weeks were compared to baseline values. RESULTS: Twelve of the 20 participants (60%) completed the study. For those who completed, the mean score on the OST decreased from 6.2 ± 1.90 (mean ± SD) at baseline to 3.4 ±1.73 at 6 weeks, indicating a mean reduction of 2.8 (95% CI, -1.6 to -3.9; P < .001). The peristomal skin condition of 9 participants improved, whereas 3 experienced no change. All participants who completed the study rated comfort, handling, security, and discretion highly (median score 10 at baseline and at 6 weeks). CONCLUSIONS: Study findings indicate the novel ostomy barrier ring may reduce levels of peristomal MASD in persons living with an ileostomy, though a more extensive trial with a control group is recommended.

Novel Pouching Techniques for the Neonate With Fecal Ostomies.

BACKGROUND: Neonatal ostomy management is challenging even under the best circumstances. When complex circumstances are encountered, creative pouching techniques must be employed. CASES: This article describes management of 5 neonates with problematic ostomies. CONCLUSION: Maintaining a neonatal pouch seal at times requires using modified adult pouching products; however, caution should always be used due to the fragility of this patient population.

Is An Ostomy Rod Useful for Bridging the Retraction During the Creation of a Loop Ileostomy? A Randomized Control Trial.

BACKGROUND: A loop ileostomy is generally created during restorative proctocolectomy (RPC) for treating ulcerative colitis (UC), and an ostomy rod is often used to prevent stoma retraction. However, its usefulness or harmfulness has not been proven. We performed a prospective randomized control study to investigate the non-inferiority of ostomy creation without a rod to prevent stoma retraction. METHODS: Patients with UC who underwent RPC were enrolled and randomly divided into groups either with or without ostomy rod use. Incidences of stoma retraction and dermatitis were compared. RESULTS: Of the 320 patients in the study groups, 308 qualified for the intention-to-treat (ITT) analysis, and 257 were included in the per-protocol (PP) analysis. Ostomy retraction was recognized in 6 patients, 3 with a rod and 3 without. The difference with rod use (95% confidence interval) was 0.1 (-2.9 to 3.1)% in the PP analysis and 0.0 (-2.2 to 2.2)% in the ITT analysis. There were no significant differences in stoma retraction regardless of whether an ostomy rod was used in either analysis. Dermatitis was more common in patients with rod use (84/154) than in those without (40/154) (p < 0.01). CONCLUSIONS: Although median body mass indices were extremely low (20 kg/m2), an ostomy rod is not routinely needed as it may increase the risk of dermatitis. However, results in obese patients may differ from those shown here, which should be clarified via further studies.