Randomised clinical trial: A 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension
Seiler C.M.,Visceral and Vascular Surgery |
Izbicki J.,University of Hamburg |
Varga-Szabo L.,Szent Pantaleon Hospital |
Czako L.,University of Szeged |
And 8 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2013
Summary Background Pancreatic exocrine insufficiency (PEI) often occurs following pancreatic surgery. Aim To demonstrate the superior efficacy of pancreatin 25 000 minimicrospheres (Creon 25000 MMS; 9-15 capsules/day) over placebo in treating PEI after pancreatic resection. Methods A 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study with a 1-year, open-label extension (OLE). Subjects ≥18 years old with PEI after pancreatic resection, defined as baseline coefficient of fat absorption (CFA) <80%, were randomised to oral pancreatin or placebo (9-15 capsules/day: 3 with main meals, 2 with snacks). In the OLE, all subjects received pancreatin. The primary efficacy measure was least squares mean CFA change from baseline to end of double-blind treatment (ancova). Results All 58 subjects randomised (32 pancreatin, 26 placebo) completed double-blind treatment and entered the OLE; 51 completed the OLE. The least squares mean CFA change in the double-blind phase was significantly greater with pancreatin vs. placebo: 21.4% (95% CI: 13.7, 29.2) vs. -4.2% (-12.8, 4.5); difference 25.6% (13.9, 37.3), P < 0.001. The mean ± s.d. CFA increased from 53.6 ± 20.6% at baseline to 78.4 ± 20.7% at OLE end (P < 0.001). Treatment-emergent adverse events occurred in 37.5% subjects on pancreatin and 26.9% on placebo during double-blind treatment, with flatulence being the most common (pancreatin 12.5%, placebo 7.7%). Only two subjects discontinued due to treatment-emergent adverse events, both during the OLE. Conclusions This study demonstrates superior efficacy of pancreatin 25 000 over placebo in patients with PEI after pancreatic surgery, measured by change in CFA. Pancreatin was generally well tolerated at the high dose administered (EudraCT registration number: 2005-004854-29). © 2013 Blackwell Publishing Ltd.
Strey C.W.,Visceral and Vascular Surgery
World Journal of Surgery | Year: 2014
Incisional hernias remain a surgical challenge when balancing surgical morbidity, functional restoration, and risk of recurrence. Laparoscopic intraperitoneal onlay mesh (IPOM) placement reduces postoperative wound infections and allows fast patient recovery. Yet, current IPOM techniques do not achieve closure of the midline hernia gap, thereby increasing the risk of persistent mesh bulging with poor abdominal wall function. We propose a novel triple-step hernia repair technique that includes tension-free midline reconstruction. It is achieved through laparoscopic dorsal component separation and laparoscopic suture closure of the midline with a 1.0 polydioxanone suture sling. Combining dorsal abdominal wall component separation, a midline closure with adequate suture strength, and IPOM reinforcement merges the benefits of open and laparoscopic hernia repair. This triple-step technique allows static and functional laparoscopic abdominal wall reconstruction. © 2014 The Author(s).
Habbe N.,Goethe University Frankfurt |
Hannes S.,Goethe University Frankfurt |
Liese J.,Goethe University Frankfurt |
Woeste G.,Goethe University Frankfurt |
And 2 more authors.
International Journal of Colorectal Disease | Year: 2014
Purpose: Wound infections affect not only the individual patient but lead to an increase in medical costs. After ileostomy reversal, surgical site infections are a common problem. The objective of the study was to compare the infection rates of purse-string and conventional skin closure techniques in a high volume setting. Methods: Patients undergoing ileostomy reversal at the Goethe University Hospital between January 2009 and August 2012 were retrospectively analysed regarding surgical site infections and associated risk factors. Patients received either conventional skin closure (running, interrupted or stapled suturing; group C) or subcuticular purse-string suture (group PS). Results: In total, 114 patients have been analysed. Conventional wound closure was performed in 81 patients and 33 patients received purse-string skin closure. The groups did not differ regarding age, gender, indication for ileostomy, previous chemotherapy, and operation time. Median hospital stay was 7 days (3-34) in group PS and 8 (3-53) in group C (p=0.15). Wound infections only occurred in groups C (n=10, 12%) compared to group PS (n=0; 0%; p=0.034), and the wound closure technique was the only significant factor associated with surgical site infection. Surgery performed by a resident under supervision was not a risk factor for complications compared to the procedure done by a senior surgeon (p =0.73). Conclusion: This study reveals an advantage of the purse-string skin closure technique in ileostomy reversals analysing a large cohort of patients. Therefore, we recommend the use of the purse-string skin closure in ileostomy reversals as one way to lower wound infection rates. © Springer-Verlag Berlin 2014.
Seifarth C.,Charite - Medical University of Berlin |
Pohlen U.,Visceral and Vascular Surgery |
Kroesen A.J.,Visceral Surgery and Traumatology |
Siegmund B.,Charite - Medical University of Berlin |
And 2 more authors.
International Journal of Colorectal Disease | Year: 2014
Background: Severe courses of Crohn's disease (CD) during pregnancy are rare. However, if occurring, the risk of miscarriage and low birth weight is increased. At present, only limited data is available on the treatment of CD during pregnancy. In particular, there are no standard guidelines for surgical therapy. Nevertheless, surgery is often unavoidable if complications during the course of the disease arise. Purpose: This study provides a critical overview of conventional and interventional treatment options for CD complications during pregnancy and analyses the surgical experience gained thus far. For illustrative purposes, clinical cases of three young women with a severe clinical course during pregnancy are presented. Methods: After treatment-refractory for conservative and interventional measures, surgery remained as the only treatment option. In all cases, a split stoma was created after resection to avoid anastomotic leaks that would endanger the lives of mother and child. The postoperative course of all three patients was uneventful, and pregnancy remained intact until delivery. No further CD specific medication was required before birth. Conclusions: The management of CD patients during pregnancy requires close interdisciplinary co-operation between gastroenterologists, obstetricians, anaesthetists and visceral surgeons. For the protection of mother and child treatment should thus be delivered in a specialised centre. This article demonstrates the advantages of surgical therapy by focusing on alleviating CD complaints and preventing postoperative complications. © Springer-Verlag 2014.
Kaufmann R.,Friedrich - Schiller University of Jena |
Hascher A.,Friedrich - Schiller University of Jena |
Mubbach F.,Friedrich - Schiller University of Jena |
Henklein P.,Humboldt University of Berlin |
And 3 more authors.
Histochemistry and Cell Biology | Year: 2012
In this study, we demonstrate functional expression of the proteinase-activated receptor 2 (PAR2), a member of a G-protein receptor subfamily in primary cholangiocarcinoma (PCCA) cell cultures. Treatment of PCCA cells with the serine proteinase trypsin and the PAR 2-selective activating peptide, furoyl-LIGRLO-NH2, increased migration across a collagen membrane barrier. This effect was inhibited by a PAR2-selective pepducin antagonist peptide (P2pal-18S) and it was also blocked with the Met receptor tyrosine kinase (Met) inhibitors SU 11274 and PHA 665752, the MAPKinase inhibitors PD 98059 and SL 327, and the Stat3 inhibitor Stattic. The involvement of Met, p42/p44 MAPKinases and Stat3 in PAR2-mediated PCCA cell signaling was further supported by the findings that trypsin and the PAR2-selective agonist peptide, 2-furoyl-LIGRLO-NH2, stimulated activating phosphorylation of these signaling molecules in cholangiocarcinoma cells. With our results, we provide a novel signal transduction module in cholangiocarcinoma cell migration involving PAR2-driven activation of Met, p42/ p44 MAPKinases and Stat3. © Springer-Verlag 2012.