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.

Lumbar bone mineral density in very long-term renal transplant recipients: impact of circulating sex hormones.

The influence of circulating sex hormones and gender on the bone mineral density (BMD) in long-term renal transplant recipients needs further investigation. We performed a retrospective analysis of lumbar BMD between 6 years and 20 years after renal transplantation. In 67 patients (47+/-12 years, 38 male) with a minimum interval of 72 months after transplantation, lumbar BMD measurements (dual energy X-ray absorptiometry) were performed (=complete cohort). Thirty-one patients (=longitudinal cohort) underwent at least three serial BMD measurements (mean follow-up 39+/-18 months, start at 86+/-22 months). All patients received prednisolone. In the complete cohort, BMD was significantly reduced in comparison to young healthy (mean T-score -1.33+/-1.40) and age-matched controls (mean Z-score -0.91+/-1.45) at 88+/-31 months (p<0.05). Osteopenia or osteoporosis were present in two-thirds of patients. In the longitudinal cohort, a mean annual lumbar BMD loss of -0.6+/-1.9% was detectable equivalent to a -0.03+/-0.15 reduction of Z-scores per year (regression analysis). Impact of hormonal status: In the complete cohort, postmenopausal status was associated with significantly lower BMD levels compared to men (p=0.0441). Women and men within the lowest tertile of sex hormone levels (LH, FSH, DHEAS, testosterone, progesterone, estradiol) did not exhibit significant differences in terms of lumbar BMD compared to those in the highest tertile. The mean annual bone loss was statistically indistinguishable between men and women. There was no significant correlation of sex hormone levels and BMD in men and premenopausal women. In postmenopausal women, however, low estradiol and high LH levels correlated with the extent of annual BMD loss (p<0.05). Our data confirm significantly reduced lumbar T-scores in the very late period after renal transplantation. The lumbar BMD decreased by -0.6+/-1.9% per year. In postmenopausal long-term renal transplant recipients, low estradiol levels were associated with accelerated bone loss.

Early rapid loss followed by long-term consolidation characterizes the development of lumbar bone mineral density after kidney transplantation.

BACKGROUND: Bone mineral density (BMD) decreases significantly early after renal transplantation. This prospective study was designed to evaluate the long-term lumbar BMD development. METHODS: Sixty-three renal-transplant recipients (mean age 44 +/- 12 years, 37 [59%] male) underwent serial yearly posttransplant laboratory parameter and BMD measurements of the lumbar spine (dual energy x-ray absorptiometry). Combined maintenance immunosuppression included prednisolone in 95% of patients. The minimum number of consecutive scans was three; the maximum number seven (n = 15). Examinations were performed between 3 +/- 2 and 68 +/- 4 months posttransplant. RESULTS: BMD was significantly lower compared with healthy controls at all times after transplantation. t scores were below -1. BMD development revealed a biphasic pattern: between 3 +/- 2 and 10 +/- 2 months, a significant BMD decrease of -0.016 +/- 0.055 g/cm2 (-1.6%, P = 0.024) occurred. Later, a moderate increase resulting in BMD stability until the sixth year posttransplant was detected. Within the first year, posttransplant osteocalcin (from 19 +/- 15 to 32 +/- 23 microg/L) and calcitriol (from 24 +/- 15 to 43 +/- 24 ng/L) displayed a significant increase. Compared with patients with a pronounced decrease, patients with a substantial increase in early posttransplant BMD had a lower baseline BMD (0.989 +/- 0.131 vs. 1.149 +/- 0.202 g/cm2 [P = 0.0122]) and lower creatinine levels (105 +/- 23 vs. 141 +/- 53 mmol/L [P = 0.0227]). CONCLUSION: Our study confirms a significant decrease of lumbar BMD early after renal transplantation. Bone loss was less pronounced than previously described. The longitudinal follow-up verifies a previously assumed biphasic lumbar BMD development: after the first year, no further significant bone loss occurred, and bone density remained relatively stable at significantly lower levels compared with healthy controls.