The QUILT study: quilting sutures in patients undergoing breast cancer surgery: a stepped wedge cluster randomized trial study.

BACKGROUND: Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting suture technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND). METHODS: The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and no increased use of postoperative analgesics. A total of 113 patients is required based on a sample size calculation. Secondary outcomes are shoulder function, cosmetic outcome, satisfaction with thoracic wall and health care consumption. Follow-up lasts for 6 months. DISCUSSION: This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. We hypothesize that quilting is a simple technique to increase textbook outcome, enhance patient comfort and reduce health care consumption.

Management of pulmonary hypertension in neonates with congenital diaphragmatic hernia.

Pulmonary hypertension associated with congenital diaphragmatic hernia is still one of the major challenges in neonatal intensive care units. Several relevant pathways in its pathogenesis have been described and studied, but the absence of well-designed randomized controlled trials and the scattered data on the pharmacokinetics and pharmacodynamics of most of the drugs used in these patients hamper progress significantly. This review aims to give an overview of current management strategies in the antenatal and neonatal phase, and provides founded clinical recommendations.

Minimal access surgery for repair of congenital diaphragmatic hernia: is it advantageous?--An open review.

INTRODUCTION: Congenital diaphragmatic hernia (CDH) is a congenital life-threatening condition requiring surgical repair in the neonatal period. Minimal access surgery (MAS) is gaining ground on the classical open approach by laparotomy or thoracotomy as it minimizes damage to the abdominal or thoracic wall. Using an open review of the literature, we aimed to determine whether MAS is safe and effective in treating CDH. Furthermore, we provide selection criteria for the optimal surgical approach, laid down in a decision algorithm. METHODS: An online search of MEDLINE was performed (May 2012), followed by a citations search. All study types except case reports describing open and/or MAS repair of Bochdalek CDH were eligible. Primary outcome data, for example, surgical complications and mortality, were recorded, as well as secondary outcome measures, for example, operative time, duration of postoperative ventilation, tolerance of enteral nutrition, and total length of stay (LOS) in hospital. Analysis was performed in accordance with the standards of the Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: We identified 15 relevant studies, 5 of them describing MAS only and 10 comparing MAS to open repair of CDH. Numbers of included patients and selection criteria for MAS varied widely. Most studies have methodological limitations, such as the use of retrospective data or historical control groups. ECMO treatment and patch use were more frequent in the open repair group (both p < 0.0001). Recurrence risk seemed to be increased in the MAS group. The need for conversion in MAS series ranged widely, from 3.4 to 75.0%. The risk of general surgical complications did not vary between groups. Mortality seemed to be less in the MAS group. Operative time seemed to be longer in the MAS group. Duration of postoperative ventilation and total LOS appeared to be reduced in this group and patients returned quicker to enteral nutrition. CONCLUSIONS: We demonstrate that MAS for diaphragmatic hernia appears to be safe in terms of complications and mortality. Besides, it is associated with faster postoperative recovery. Growing experience with this technique is expected to lower the recurrence risk and to shorten the operative time. These findings should be interpreted cautiously because of methodological limitations of the studies included. Selection criteria used in various studies are associated with an important risk of selection bias. Nonetheless, these criteria can be used to identify patients who will benefit most from MAS.

Hip fracture surgery and performance indicators: an analysis of 941 patients operated in a large teaching hospital.

BACKGROUND: In the Netherlands, two performance indicators for the treatment of hip fracture patients have been recently implemented. Both indicators state that surgery within 24 h after admission improves the outcome with regard to 1-year mortality and the amount of re-operations within 1 year. To determine the value of these performance indicators, we conducted a retrospective analysis of 941 hip fracture patients. METHODS: In the period from January 2003 to December 2006, a total of 941 consecutive hip fracture patients were included in this study. We determined the amount of re-operations and the mortality at 1 year after surgery. From June 2005 to December 2006, we could determine whether patients were operated on within 24 h after admission. In this group of 379 patients, we determined if there were differences in the 1-year mortality and the number of re-operations at 1 year with regard to the time window in which these patients were operated on (<24 h or >24 h). RESULTS: Our overall mortality rate at 1 year is 21% (202 patients) and the amount of re-operations within 1 year is 8% (77 procedures). In our subgroup analysis, we found no significant difference in mortality or re-operations if patients were operated on within 24 h or not (number needed to treat of 59 and -31, respectively). CONCLUSION: We conclude that hip fracture surgery within 24 h does not provide significantly better results in terms of 1-year mortality and the amount of re-operations within 1 year.