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.

Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.

BACKGROUND: Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period. The objective of this clinical trial was to evaluate the preliminary efficacy and safety of the Colovac+. METHODS: This was a prospective, multicenter, pilot study aiming to enroll 15 patients undergoing LAR with Colovac+ placement. After 10 days, a CT scan was performed to evaluate the anastomosis and the Colovac+ was retrieved endoscopically. During the 10-day implantation and 3-month follow-up period, we collected data regarding predefined efficacy and safety endpoints. The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure. RESULTS: A total of 25 patients were included (68% male), of whom 15 were consecutively treated with the Colovac+ and Vacuum Loss Alert System. The Colovac+ was successfully implanted in all 15 patients. No major discomfort was reported during the implantation period. The endoscopic retrieval was performed in 14/15 (93%) patients. The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. A device migration occurred in 2 (13%) patients, but these were not associated with AL or stoma conversion. Overall, Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the PI in 11/15 (73%) patients. CONCLUSIONS: Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the majority (73%) of patients. The improved design reduces the overall migration rate and limits the clinical impact of a migration.

Symptomatic arterial thrombosis associated with novel coronavirus disease 2019 (COVID-19): report of two cases.

Since December 2019, the outbreak of the novel coronavirus disease (COVID-19) in China has rapidly spread throughout the world. During the course of the COVID-19 pandemic, thrombotic complications have emerged as an important issue. We present two cases of symptomatic arterial thrombosis in patients with confirmed COVID-19. The first patient presented with digital ischemia due to distal embolization from a floating thrombus in the proximal left subclavian artery, and the second one with bilateral acute limb ischemia due to thrombosis of the right popliteal artery and left tibioperoneal trunk. This case report illustrates that arterial thrombosis associated with COVID-19 can occur even in the absence of severe respiratory disease and clinically relevant peripheral arterial disease.

Metastatic melanoma causing small intestinal perforation at the jejunojejunostomy after Roux-en-Y gastric bypass: a case report.

BACKGROUND: Metastatic melanoma of the small intestine is relatively common, and among affected patients, the proportion with involvement of the small intestine ranges from 35% to 70%. Small intestinal perforation as a primary manifestation of metastatic melanoma is rare. We present the exceptional case of a perforation at the jejunojejunostomy after Roux-en-Y gastric bypass caused by metastatic melanoma. CASE PRESENTATION: A 59-year-old woman with a history of a laparoscopic Roux-en-Y gastric bypass and toe amputation due to malignant melanoma (stadium IIIC) presented with an acute abdomen. The abdominal computed tomography scan showed a covered perforation at the jejunojejunostomy of the gastric bypass. The patient underwent an urgent surgical exploration revealing massive tumoral invasion of the anastomosis. The tumoral mass and anastomosis were resected and a new jejunojejunostomy was created. Histopathological examination identified the tumor as a malignant melanoma, so the current abdominal lesions were presumed to be metastases. The postoperative course was uneventful and adjuvant immunotherapy was started a week later. One year after surgery she was doing well with maintenance immunotherapy and there was no evidence of recurrent metastatic disease. CONCLUSION: We report the first case of a perforation at the jejunojejunostomy after Roux-en-Y gastric bypass caused by metastatic melanoma. This exceptional case illustrates that a history of malignant melanoma in case of an acute abdomen should raise suspicion of possible metastatic disease.

Evaluation of the SafeHeal Colovac+ Anastomosis Protection Device: A Preclinical Study.

BackgroundThe protective ostomy is the current standard of care to protect a low colorectal anastomosis from leakage, but exposes patients to complications requiring an alternative strategy. The Colovac+ is a vacuum-based intraluminal bypass device designed to shield the anastomosis from fecal content, preventing the clinical outcomes of anastomotic leakage. The objective of this study was to evaluate the preliminary efficacy, safety, and technical feasibility of the Colovac+ in a porcine model. Methods: Twelve pigs received a colorectal anastomosis with Colovac+ implantation. The device was left in situ for 10 days and then retrieved endoscopically. Six pigs were to be sacrificed immediately after device retrieval and the other 6 were to be sacrificed on day 38. Clinical, endoscopic, and histopathological examinations were performed to evaluate the following endpoints: prevention of contact between the anastomosis and fecal content, device migration, feasibility of the implantation and retrieval procedure, collateral damage to the colonic wall, colon healing after device retrieval, and systemic toxicity related to the device. Results: Eleven pigs completed the study. One pig died prematurely due to a surgical complication unrelated to the device (bladder damage with uroperitoneum). There was no evidence of contact between the anastomosis and fecal content, none of the pigs developed symptomatic anastomotic leakage, there were no significant device migrations, and there was no evidence of systemic toxicity. Colovac+ implantation was easily performed in all cases except 1 (due to an inappropriate lubricant). Colovac+ retrieval was achieved successfully in all cases. Postretrieval examinations on day 10 revealed ulcerations at the anchoring site in 4 cases indicating mechanical damage caused by the stent. However, in the recovery group, no ulcerations were observed on day 38, and the colonic wall had properly healed in all animals. Conclusions: The Colovac+ is a technically feasible, safe, and efficient device for the protection of a colorectal anastomosis in a porcine model. The device holds promise for clinical use and warrants further research.

Fistulectomy and primary sphincteroplasty (FIPS) to prevent keyhole deformity in simple anal fistula: a single-center retrospective cohort study.

OBJECTIVE: Fistulotomy remains the gold standard for the surgical treatment of simple anal fistula, but may cause fecal incontinence and a characteristic anal 'keyhole' deformity. Although seemingly trivial, keyhole deformity may lead to bothersome symptoms such as anal pruritus and fecal soiling. This study aims to evaluate the efficacy of fistulectomy and primary sphincteroplasty (FIPS), a technique with immediate sphincter reconstruction, in the treatment of simple anal fistula and the prevention of keyhole deformity created by simple fistulotomy. METHODS: A retrospective study was performed on all consecutive patients who underwent FIPS for a simple anal fistula at our institution between January 2015 and August 2019. The primary outcome of the study was the rate of early postoperative wound dehiscence, which essentially transforms a FIPS into a simple fistulotomy and may lead to keyhole deformity. All patients received follow-up at regular intervals to evaluate fistula healing and the presence of keyhole deformity. RESULTS: FIPS was performed in 24 patients (median age: 52.8 years). After a median follow-up time of 3.0 (2.0, 6.3) months, the overall healing rate was 95.8% (23/24 patients). Six (25%) patients experienced early postoperative wound dehiscence resulting in the development of a keyhole deformity. Five of them were symptomatic (mainly soiling). Keyhole deformity was diagnosed at a median time of 6.0 (3.8, 7.5) months postoperatively. The occurrence of early wound dehiscence and subsequent keyhole deformity was associated with a posteriorly located fistula (p = .02). CONCLUSION: FIPS avoids the development of keyhole deformity in the majority of patients with simple anal fistula, but is less successful in posterior fistulas. Since FIPS is a very effective, fast and simple procedure, it should be considered a valid alternative for the treatment of every simple anal fistula.

Primary midgut volvulus without intestinal malrotation in a young adult: a case report.

BACKGROUND: Midgut volvulus is a rare cause of acute abdomen characterized by a twisting of the entire small intestine around its mesenteric pedicle. It is a well-known complication of intestinal malrotation usually occurring in infants and young children. We report a rare case of a midgut volvulus without any underlying condition occurring in a young adult. CASE PRESENTATION: A 24-year-old male was admitted to our surgical department with symptoms and signs of small bowel obstruction. The abdominal computed tomography (CT) scan showed dilatation of the entire small intestine and a rotation of the mesentery. The patient underwent an urgent explorative laparoscopy with conversion to median laparotomy, revealing a midgut volvulus with marked intestinal ischemia. Mesenteric fixation was normal but the mesenteric pedicle was described as relatively narrow. The midgut volvulus was untwisted with subsequent recovery of the intestinal ischemia. RESULTS: The postoperative period was marked by prolonged ileus requiring nasogastric tube decompression that gradually resolved after 1 week. The patient was discharged on the tenth postoperative day. He had fully resumed his daily activities 1 month after surgery and had experienced no recurrent symptoms 6 months later. CONCLUSION: Primary midgut volvulus is an extremely rare condition that must be considered in all young adults presenting with intestinal obstruction without previous abdominal surgery. Early diagnosis and immediate surgical intervention are the key factors to a successful outcome.

Biomarkers and Donor Selection in Heart Transplantation.

BACKGROUND: Previously, we showed that B-type natriuretic peptide (BNP) measured in the donor was related to cardiac performance after cardiac transplantation. The present study assesses the value of 3 biomarkers in the selection of donor hearts in a larger cohort. METHODS: Blood samples were prospectively obtained in 105 brain-dead patients scheduled for heart donation. BNP, soluble suppressor of tumorigenicity 2 (ST2), and troponin of heart donors were correlated with hemodynamic parameters early after transplantation as well as with the mortality of the recipients. RESULTS: A significant inverse relationship was found between donor BNP measured at the time of donation and recipient cardiac index and cardiac output at day 13 post-transplantation (r = -0.31, P = .005, and r = -0.34, P = .0016, respectively). Logistic regression analysis-including BNP, ST2, and troponin-showed that donor BNP was a predictor of a poor cardiac index (< 2.2 L/min/m2) in the recipient (P = .04). A donor BNP > 132 pg/mL has a sensitivity of 56% (95% confidence interval 21-86) and a specificity of 86% (95% confidence interval 77-93) to predict poor cardiac performance in the recipient. When the donor BNP is ≤ 132 pg/mL, the risk of a poor cardiac function in the recipient is very low (negative predictive value 94%). Mortality at 30 days was also correlated to donor BNP (r = 0.29, P = .0029). Long-term survival of the recipient was not correlated to the biomarkers measured in the donor. CONCLUSION: Donor BNP, but not donor ST2 or high-sensitivity troponin, provides information on the donor heart and early post-transplant performance, including 1-month mortality.

Alternative Approach for the Surgical Treatment of Left Main Coronary Artery Aneurysm.

Left main coronary artery (LMCA) aneurysm is a very rare condition that usually requires surgical treatment. Although there is no consensus on the standard surgical technique, aneurysmal ligation with coronary artery bypass grafting is commonly used. This report presents a case of a giant LMCA aneurysm for which an alternative surgical approach was performed. The aneurysm was incised and partially resected. An interposition right internal thoracic artery graft from the LMCA to the left circumflex coronary artery was placed together with a left internal thoracic artery and free right internal thoracic artery graft. Postoperative imaging showed good patency of all grafts. This case demonstrates an effective approach for the surgical treatment of LMCA aneurysm that offers an alternative when other techniques are not desirable.

Fistula-tract Laser Closure (FiLaC™) for complex urethroperineal fistula.

BACKGROUND: Fistula formation in hidradenitis suppurativa follows an uncontrolled infection with subcutaneous tracts leading to 'watering-can' or 'pus-pot' perineum. Closure of this type of fistula implies major surgery and is bound to fail in refractory inflammatory environment. Minimally invasive techniques have become the first line of choice in every type of surgery. METHODS: Fistula-tract Laser Closure (FiLaC™, Biolitec, Germany) is a novel technique already reported to have been used in the treatment of fistula-in-ano and pilonidal sinus. It consists of blind cauterization and obliteration of the fistula tract from the inside by means of a radial-emitting laser probe. We present two patients who underwent surgery for urethroperineal fistula using this technique. RESULTS: In both cases, the fistula tracts were completely closed after 3 months of follow-up. The wounds had healed smoothly and complete resolution of symptoms was noted. CONCLUSIONS: The use of FiLaC™ for the treatment of urethroperineal fistula is feasible and safe. The minimally invasive nature of the technique and limited postoperative pain permit daycare surgery.