SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Short-term outcomes of the "minimal skin incision and no stoma" procedure in needlescopic intersphincteric resection and delayed coloanal anastomosis for low rectal cancer.

BACKGROUND: Needlescopic surgery is a minimally invasive procedure that uses thin trocars with 3-mm diameter. We used Turnbull-Cutait pull-through and delayed coloanal anastomosis in needlescopic surgery to avoid diverting ileostomy during intersphincteric resection for low rectal cancer. In this study, we aim to assess the diverting ileostomy avoidance rate and technical safety of this "minimal skin incision and no stoma" procedure. METHODS: This single-center retrospective study was conducted at the Cancer Institute Hospital, a tertiary referral center in Japan. Between January 2017 and December 2020, 11 patients underwent needlescopic intersphincteric resection with diverting ileostomy (NSI group), and 19 patients underwent needlescopic intersphincteric resection with delayed coloanal anastomosis (NSD group) for low rectal cancer. Data regarding patient backgrounds and short-term outcomes, including diverting ileostomy avoidance rate, pathological results, and postoperative defecatory function, were compared between the groups. RESULTS: There were no statistically significant differences between the NSI and NSD groups with respect to patient background, operation time (239 min versus 220 min, p = 0.68), estimated blood loss (45 g versus 25 g, p = 0.29), R0 resection rate (100% versus 100%, p = 1.00), and length of postoperative hospital stay (16 days versus 17 days, p = 0.42). The diverting ileostomy avoidance rate was 94.4% in the NSD group. The LARS and Wexner scores 12 months after surgery were not significantly different between the two groups. CONCLUSIONS: Needlescopic intersphincteric resection and delayed coloanal anastomosis can be safely performed in selected patients with a high rate of diverting ileostomy avoidance and comparable short-term outcomes.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Is "functional end-to-end anastomosis" really functional? A review of the literature on stapled anastomosis using linear staplers.

PURPOSES: Anastomosis is one of the basic skills of a gastrointestinal surgeon. Stapling devices are widely used because stapled anastomosis (SA) can shorten operation times. Antiperistaltic stapled side-to-side anastomosis (SSSA) using linear staplers is a popular SA technique that is often referred to as "functional end-to-end anastomosis (FEEA)." The term "FEEA" has spread without any definite validation of its "function." The aim of this review is to show the heterogeneity of SA and conventional hand-sewn end-to-end anastomosis (HEEA) and to advocate the renaming of "FEEA." METHODS: We conducted a narrative review of the literature on SSSA. We reviewed the literature on ileocolic and small intestinal anastomosis in colonic cancer, Crohn's disease and ileostomy closure due to the simplicity of the technique. RESULTS: The superiority of SSSA in comparison to HEEA has been demonstrated in previous clinical studies concerning gastrointestinal anastomosis. Additionally, experimental studies have shown the differences between the two anastomotic techniques on peristalsis and the intestinal bacteria at the anastomotic site. CONCLUSIONS: SSSA and HEEA affect the postoperative clinical outcome, electrophysiological peristalsis, and bacteriology in different manners; no current studies have shown the functional equality of SSSA and HEEA. However, the use of the terms "functional end-to-end anastomosis" and/or "FEEA" could cause confusion for surgeons and researchers and should therefore be avoided.

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.

A new stomaplasty ring (Koring™) to prevent parastomal hernia: an observational multicenter Swiss study.

BACKGROUND: Parastomal hernias (PSH) are one of the most frequent complications of enterostomies with a non-negligible complication rate and a significant socioeconomic effect. Therefore, preventing PSH by placing a mesh at the time of primary surgery has been advocated. The aim of our study was to evaluate the safety and feasibility of the new stomaplasty ring [Koring™, (Koring GmbH, Basel, Switzerland)] and investigate the reason why surgeons are reluctant to take preventive measures. METHODS: A multicenter observational study was conducted on 30 patients between December 2013 and January 2015. In permanent end colostomies and end ileostomies, the Koring™ was implanted. The primary outcome was the 30-day morbidity (infection and other stoma-related complications). Secondary endpoints were the technical feasibility and the time needed to fix the ring. In addition, an online survey of 107 surgeons was performed. RESULTS: Twenty-seven patients received permanent end colostomies, and three received end ileostomies. No stoma-related complication was detected within the first 30 days post-operatively. The Koring™ ring was evaluated by the surgeons as easy and very easy to implant in more than half of the patients. Average additional operating time for ring implantation was 19 min. CONCLUSIONS: Koring™ implantation at the time of creating the stoma is safe, easy and only adds minimally operating time. A long-term follow-up as well as a randomized controlled study is needed to evaluate the impact of the Koring™ on PSH prevention. The ease and rapidity with which Koring™ can be implanted may help surgeons to overcome their apprehension of using a preventative device.

Evaluation of a new ostomy mouldable seal: an international product evaluation.

A new mouldable seal, Brava® Protective Seal, was evaluated by patients on aspects related to residue, durability, and preference. A total of 135 patients from four countries participated (Denmark, Germany, Japan and the USA) and the new product was compared to the patients' usual pouching systems. Less residue and easier skin cleansing was observed, which may benefit patient quality of life. The possible benefits of less residue for peristomal skin health need further investigation.

Considering the benefits of a new stoma appliance: a clinical trial.

For people living with a stoma, leakage is one of the main problems compromising quality of life. The right choice of stoma appliance is therefore of utmost importance. This randomised, controlled clinical trial investigated the benefits of a new stoma appliance, SenSura Mio Convex Soft, specifically for people who experience leakage using a flat stoma appliance. The degree of leakage under the baseplate was measured using a new objective method. The study included 38 participants with an ileostomy or colostomy. Results showed that while being flexible and comfortable, the new appliance reduced leakage significantly and provided a better feeling of security when compared with the participants' own flat stoma appliance. The product was the preferred of the convex stoma appliances in the study. This study demonstrated that it may be a solution for people with a stoma challenged by leakage using flat stoma appliances.