HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040).

OBJECTIVES: The objective of the HASTA trial was to compare hand suture versus stapling loop ileostomy closure in a randomized controlled trial. BACKGROUND: Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy after low anterior resection. The best surgical technique for closure of loop ileostomy has not been defined yet. METHODS: HASTA trial is a multicenter pragmatic randomized controlled surgical trial with 2 parallel groups to compare hand suture versus stapling for closure of loop ileostomy. The primary endpoint was the rate of bowel obstruction within 30 days after ileostomy closure. RESULTS: A total of 337 randomized patients undergoing closure of loop ileostomy after low anterior resection because of rectal cancer in 27 centers were included. The overall rate of postoperative ileus after ileostomy closure was 13.4%. Seventeen of 165 (10.3%) patients in the stapler group and 27 of 163 (16.6%) in the hand suture group developed bowel obstruction within 30 days postoperatively [odds ratio (OR) = 1.72; 95% confidence interval (CI): 0.89-3.31 = 0.10]. Duration of surgical intervention was significantly shorter in the stapler group (15 minutes; P < 0.001). Multivariable analysis of potential risk factors did not reveal any significant correlation with development of postoperative ileus. Rate of anastomotic leakage (stapler: 3.0%, hand suture: 1.8%, P = 0.48) did not differ significantly as well as all other secondary endpoints. CONCLUSIONS: Hand-sewn anastomosis versus stapler ileo-ileostomy for ileostomy closure are equally effective in terms of postoperative bowel obstruction, with stapler anastomosis leading to a shorter operation time. Postoperative ileus after ileostomy reversal remains a relevant complication.

A new technique for ureteral defect lesion reconstruction using an autologous vein graft and a biodegradable endoluminal stent.

PURPOSE: Ureteral defect lesions are severe complications caused by iatrogenic lesions or trauma. For ureteral defect lesions elaborate surgical intervention is needed, such as autotransplantation or ureteral replacement with small bowel. Thus, we developed a new technique for ureteral defect reconstruction in a pig model using an autologous vein graft splinted by an endoluminal biodegradable poly-L-lactic acid stent (Institute of Textile Technology and Process Engineering, Denkendorf, Germany). MATERIALS AND METHODS: In 42 pigs we removed the external jugular vein and used it as an autologous vein graft. After median laparotomy a 3 cm segment was resected from the proximal ureter and replaced by the vein with or without an endoluminal biodegradable poly-L-lactic acid stent. As controls, we used 14 pigs. We observed survival, kidney function, and neoureteral and kidney morphological changes for 7 days and for 6 months. RESULTS: After 6 months the stent material was completely broken down and the vein graft was relined with urothelium. It resembled native ureter with cytokeratin-7 positive columnar epithelium and newly formed capillaries in the ureteral wall. All animals had normal kidney function without renal pelvis congestion. CONCLUSIONS: This new technique for ureteral defect reconstruction using an autologous vein graft and a biodegradable endoluminal stent is feasible. It is an interesting alternative in the clinic due to the preservation of physiological urine passage and the antireflux mechanism.

Morphological changes during creation of a neo-bile duct using a vein and a biodegradable endoluminal stent.

Major bile duct lesions are usually treated by a hepaticojejunostomy which is often complicated by cholangitis and liver fibrosis. The aim of this study was to investigate the morphologic features of a neo-bile duct created from a vein and a biodegradable endoluminal stent. The neo-bile duct was created using a segment of the external jugular vein which was endoluminally stented by a biodegradable poly-lactate-acid stent. In 18 pigs, the common bile duct was resected and replaced by the vein with (n = 12) or without endoluminal stent (n = 6). Six animals served as controls. Survival, liver function and morphological changes of the neo-bile duct and the liver were observed for six months. After six months, the neo-bile duct morphologically resembled the native bile duct showing Ck7-positive columnar epithelium and newly formed capillaries in the bile duct wall. The biodegradable stent disappeared after four months. All animals survived and showed normal liver function and no cholestasis. In contrast, after sole vein reconstruction of the bile duct, four animals died due to biliary peritonitis and cholangitis. Creation of a neo-bile duct which morphologically resembles the native bile duct is feasible by using a body's own vein and a biodegradable endoluminal stent.

A new technique for reconstruction of the common bile duct by an autologous vein graft and a biodegradable endoluminal stent.

The incidence of severe bile duct injuries has significantly increased since the introduction of laparoscopic cholecystectomy. The ideal reconstruction procedure for traumatic defects of the bile duct should be technically simple and should preserve both the physiological passage of bile and the sphincter of Oddi. In this article we describe a new technique for bile duct reconstruction in a pig model by means of an autologous vein graft that is splinted by a endoluminal biodegradable polylactate acid stent. In 12 pigs the external jugular vein was removed and used as an autologous vein graft. After performing a median laparotomy a 2-cm segment was resected from the bile duct. The common bile duct was reconstructed by a venous interponate that had been endoluminally stented by a biodegradable polylactate acid stent. For the examination of stent degradation, 2 pigs were sacrificed at 3, 4, and 5 months (stent degradation group) and the remaining 6 pigs at 6 months (survival group). All the pigs in the survival group survived for 6 months before being sacrificed. After 4 months the stent material had been completely broken down and the vein graft had been relined with bile duct epithelium. Thus, this new technique for bile duct reconstruction using an autologous vein graft with an endoluminal stent is simple to perform and reliable, and constitutes an interesting alternative to bilodigestive anastomosis due to the preservation of the papilla of Vateri.