Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma-related complications (ISI trial).

BACKGROUND: Ileostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous versus transcutaneous suturing of ileostomies on faecal leakage and quality of life. METHODS: This randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma-related quality of life and costs of stoma-related materials and reinterventions. RESULTS: Between April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (52·4 versus 41·4 per cent respectively; risk difference 11·0 (95 per cent c.i. 0·3 to 21·2) per cent). Skin irritation rates were high (78·2 versus 72·2 per cent), but did not differ significantly between the groups (risk difference 6·1 (95 per cent c.i. -3·2 to 15·10) per cent). There were no significant differences in quality of life or costs between the groups. CONCLUSION: Intracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma-related complications did not differ between the two techniques. Registration number: NTR2369 ( http://www.trialregister.nl).

The influence of CO2 versus helium insufflation or the abdominal wall lifting technique on the systemic immune response.

BACKGROUND: Both laparoscopic and conventional surgery result in activation of the systemic immune response; however, the influence of the laparoscopic approach, using CO2 insufflation, is significantly less. Little is known about the influence of alternative methods for performing laparoscopy, such as helium insufflation and the abdominal wall lifting technique (AWLT), and the systemic immune response. METHODS: Thirty-three patients scheduled for elective cholecystectomy were randomly assigned to undergo laparoscopy using either CO2 or helium for abdominal insufflation or laparoscopy using only the AWLT. The postoperative inflammatory response was assessed by measuring the white blood cell count, C-reactive protein (CRP) and interleukin-6 (IL-6). The postoperative immune response was assessed by measuring monocyte HLA-DR expression. RESULTS: CRP levels were significantly higher 1 day after helium insufflation when compared with CO2 insufflation; however, no differences were observed 2 days after surgery. The AWLT resulted in significantly higher levels of CRP both 1 and 2 days after surgery when compared with either CO2 or helium insufflation. A small increase in postoperative IL-6 levels was observed in all groups, but no significant differences were seen between the groups. After both helium insufflation and AWLT a significant decrease in HLA-DR expression was observed, in contrast to the CO2 group. CONCLUSION: Carbon dioxide used for abdominal insufflation seems to limit the postoperative inflammatory response and to preserve parameters reflecting the immune status. These findings may be of importance in determining the preferred method of laparoscopy in oncologic surgery.

Fissurectomy and isosorbide dinitrate for chronic fissure in ano not responding to conservative treatment.

BACKGROUND: Although lateral sphincterotomy heals chronic fissure in ano in over 90 per cent of cases it is a surgical technique with inherent complications. To avoid such complications, chronic fissure in ano was treated by fissurectomy in this study. To enhance postoperative tissue perfusion allowing stable wound healing, fissurectomy was combined with temporary chemical sphincterotomy by a nitric oxide donor cream. METHODS: Seventeen consecutive patients (ten women) with chronic fissure in ano not responding to conservative management underwent diathermy fissurectomy. After operation patients used a 1 per cent isosorbide dinitrate cream. Postoperative follow-up continued until wounds had healed, at which time anal endosonography was performed. A telephone inquiry into fissure recurrence and continence status was made. RESULTS: Seventeen patients underwent fissurectomy, without postoperative complications. All wounds had healed within 10 weeks. No fissure recurrence was seen after a median follow-up of 29 months. Histopathology showed non-specific scar tissue without signs of internal anal sphincter fibrosis. Postoperative endosonography showed no evidence of new internal sphincter defects. CONCLUSION: In the treatment of chronic anal fissure not responding to chemical sphincterotomy with nitric oxide donors, fissurectomy in combination with isosorbide dinitrate cream may be a sphincter-sparing surgical technique.

Nationwide decline in annual numbers of abdomino-perineal resections: effect of a successful national trial?

OBJECTIVE: Large national trials may influence surgical practice. In this study the relation between the successful national randomized trial on the management of rectal cancer (the Dutch TME trial) and national ratio of abdomino-perineal resection to low anterior resection and anastomosis was analysed. PATIENTS AND METHODS: In the study period, 1994-99, 15978 patients underwent either abdomino-perineal resection (n = 2575) or low anterior resection and anastomosis (n = 13403). The Dutch TME trial started in 1996 and a total of 1530 patients were included by 83 hospitals and 82.1% of these patients were treated from 1997 to 1999. Teaching sessions, tutor assisted surgery and quality control formed an integral and important part of the TME trial. RESULTS: Ratio of abdomino-perineal resection vs. low anterior resection was compared between period I (1994-96) and period II (1997-99). The ratio decreased from 0.19 to 0.13 between period I and II (95% CI, -0.08 to -0.04, P < 0.001). In hospital mortality rate did not change between period I and II (3.5 vs. 3.7, 95% CI, -0.08 to 0.03, P=0.385). CONCLUSION: Significant changes in surgical attitude may accompany successful national randomized trials in which investigated surgical procedures are specified, taught, and controlled. The APR ratio declined by 32% in the Netherlands during and following the Dutch TME trial, without a rise in hospital mortality rate for rectal resections.