ABSTRACT
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.
Subject(s)
Ileostomy/methods , Rectal Neoplasms/surgery , Suture Techniques , Aged , Anastomosis, Surgical , Chi-Square Distribution , Female , Germany/epidemiology , Humans , Intestinal Obstruction/epidemiology , Male , Postoperative Complications/epidemiology , Rectal Neoplasms/epidemiology , Risk Factors , Surgical Stapling , Treatment OutcomeABSTRACT
Melatonin plays a protective role in experimental acute pancreatitis (AP) because of its antioxidative, antiinflammatory, and immunomodulatory effects. This study presents the first data on the dynamic changes of endogenous melatonin in the early phase of human AP. Morning (08:00 hr) serum melatonin concentrations were measured by ELISA in 75 patients with AP for the first 5 days after the onset of pain. According to the Atlanta classification, 26 patients suffered a mild AP (MAP). The other 49 developed a severe AP (SAP). Median melatonin concentrations of healthy volunteers were used as a control. Median melatonin level in healthy controls was 18.5 pg/mL. Levels of melatonin were significantly higher in the first 24 hr after onset of disease in patients with MAP compared to those with SAP, 51.2 versus 8.7 pg/mL (P = 0.01). Melatonin values were the same in MAP and SAP during the remainder of the study period. Melatonin concentrations during the first 24 hr after the onset of pain in younger patients (<35 yrs old) were significantly higher than levels in older patients (>35 yrs): 73 versus 8.7 pg/mL (P = 0.01). No correlation existed between melatonin levels and the following parameters: gender, etiology (biliary versus alcohol induced), and histological findings (edematous versus necrotizing versus infected necrosis). High endogenous melatonin serum levels in the first 24 hr after the onset of AP played a protective role and favoured a mild course of the disease in humans, especially in young patients.
