Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial.

BACKGROUND: Evidence is accumulating that, similar to other ventral hernias, umbilical and epigastric hernias must be mesh repaired. The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed. In laparoscopic repair, a mesh is placed intraperitoneally, while the most common procedure is open surgery is pre-peritoneal mesh placement. A recently developed alternative method is the so-called patch repair, in this approach a mesh can be placed intraperitoneally through open surgery. In theory, such patches are particularly suitable for small hernias due to a reduction in the required dissection. This simple procedure is described in several studies. It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes. The material of the patch is in direct contact with intra-abdominal organs, it is unknown if this leads to more complications. On the other hand, the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications. METHODS/DESIGN: 346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial, comparing mesh repair with patch repair. Randomisation will take place for the two operation techniques. The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch®. Stratification will occur per centre. Post-operative evaluation will take place after 1, 3, 12 and 24 months. The number of complications requiring treatment is the primary endpoint. Secondary endpoints are Verbal Descriptor Scale (VDS) pain score and VDS cosmetic score, operation duration, recurrence and costs. An intention to treat analysis will be performed. DISCUSSION: This trial is one of the first in its kind, to compare different mesh devices in a randomized controlled setting. The results will help to evaluate mesh repair for epigastric an umbilical hernia, and find a surgical method that minimizes the complication rate. TRIAL REGISTRATION: Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10.

Removable and repositionable covered metal self-expandable stents for leaks after upper gastrointestinal surgery: experiences in a tertiary referral hospital.

BACKGROUND: Anastomotic leakages are severe complications of upper gastrointestinal surgery with serious morbidity and mortality. Until recently, only abscess drainage was possible. Since 2007, removable and repositionable covered metal self-expandable stents (RReCoMSeS) have been used in our hospital to cover leaks. METHODS: Patients with postsurgical gastrointestinal leaks treated with RReCoMSeS between January 2007 and March 2010 were retrospectively evaluated and described. RESULTS: Twenty-six patients were treated with RReCoMSeS (totally covered Choo/Hanaro and partially covered Endoflex stents). Included patients had anastomotic leaks after esophagectomy (15) and bariatric surgery (11). Overall successful sealing of the leak occurred in 81 % (including multiple procedures). In total 33 RReCoMSeS were used (mean 1.3 stents and 1.7 procedures per patient). Twenty-one of 33 RReCoMSeS succeeded in sealing the leak (64 %). Migration occurred in 24 % RReCoMSeS, and 9 % disintegrated. One stent (3 %) caused a perforation. CONCLUSIONS: RReCoMSeS are a safe alternative for treating postsurgical leaks in the upper gastrointestinal tract. In 81 % of patients and with 64 % of the inserted stents, leaks were sealed successfully, with few complications. Fewer stents per patient were needed thanks to their repositionability. Stent migration is a major problem.

Addition of biological therapies to palliative chemotherapy prolongs survival in patients with peritoneal carcinomatosis of colorectal origin.

OBJECTIVES: Combination chemotherapy regimens have shown promising results in patients with metastatic colorectal cancer. However, only very few studies have studied the effect of palliative chemotherapy in peritoneal carcinomatosis (PC) and no data are present incorporating biological therapies in the treatment of PC in colorectal cancer. METHODS: By means of merging with the regional Eindhoven Cancer Registry, all consecutive patients diagnosed with synchronous PC of colorectal origin since the year 2000 treated with palliative chemotherapy in our hospital were included. Data on chemotherapeutic agents used were collected retrospectively. The effect of biological therapies on survival was investigated. RESULTS: Fifty consecutive patients were included. Chemotherapeutic treatment consisted mainly of 5-fluorouracil-based chemotherapy with oxaliplatin. In 22 patients biological therapies were added. Overall survival was 12.5 months [95% confidence interval (CI), 9.2-15.5]. In patients receiving chemotherapy in combination with a biological therapy, overall survival was significantly prolonged as compared with those treated without (18.2 months, 95% CI, 9.5-27.0 vs. 10.1 mo, 95% CI, 6.2-14.1, respectively; P=0.001). Prolongation of survival of patients receiving biological therapies in first-line treatment was even more pronounced, being 22.4 months (95% CI, 15.0-29.5). Similar effects were observed on progression-free survival. CONCLUSIONS: Systemic chemotherapy, once regarded as futile in patients suffering from PC, resulted in an overall survival of 12 months in this unselected group of PC-patients. Addition of biological therapies in the first line of treatment prolonged overall survival to 22.4 months. Although the results of this small study should be interpreted with caution, this promising finding warrants further research.

C-reactive protein concentration is associated with prognosis in patients suffering from peritoneal carcinomatosis of colorectal origin.

PURPOSE: Only a limited number of patients with peritoneal carcinomatosis (PC) of colorectal origin benefit from palliative chemotherapy. Identification of prognostic factors may aid in patient selection. The plasma concentration of C-reactive protein (CRP) is increasingly recognized as prognostic factor in a variety of malignancies. However, its value in peritoneal PC of colorectal origin is currently unknown. The aim of the present study was to investigate the association of plasma CRP concentrations with survival in patients suffering from PC of colorectal origin who receive palliative chemotherapy. METHODS: Fifty patients with colorectal PC were identified from the Eindhoven Cancer Registry. Relevant data were retrieved from their clinical records. The most discriminatory CRP concentration was identified and patients were stratified accordingly, resulting in a group with low and a group with high CRP concentrations. Further comparisons were made between these groups. RESULTS: A CRP concentration <35 mg/L was associated with a better prognosis (median survival 22.4 months) than a CRP concentration ≥35 mg/L (7.9 months) (p = 0.0002). CRP concentrations were inversely related to albumin concentrations which could predict survival at a cut-off value of 35 g/L (median survival 7.2 vs. 12.9 months, p = 0.01). High CRP concentrations were related to a decreased resectability rate of the primary tumor. CONCLUSION: Elevated CRP plasma concentrations are associated with decreased survival in patients with colorectal PC. This reflects the importance of inflammation in cancer survival. Further research is warranted to assess the clinical applicability of the current findings.