Subject(s)
Cholecystectomy, Laparoscopic/legislation & jurisprudence , Common Bile Duct/surgery , Medical Errors/legislation & jurisprudence , National Health Programs/legislation & jurisprudence , Conversion to Open Surgery/legislation & jurisprudence , Expert Testimony/legislation & jurisprudence , Germany , Guideline Adherence/legislation & jurisprudence , Humans , Postoperative Complications/etiologyABSTRACT
BACKGROUND: Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro Mesh). METHODS/DESIGN: In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention. DISCUSSION: This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients. TRIAL REGISTRATION: NCT00646334.
Subject(s)
Absorbable Implants , Biocompatible Materials/therapeutic use , Hernia, Ventral/surgery , Surgical Mesh , Adult , Clinical Protocols , Dioxanes , Double-Blind Method , Female , Humans , Male , Patient Satisfaction , Pilot Projects , Polyesters , Polypropylenes , Prospective Studies , Treatment OutcomeABSTRACT
AIM: Multimodal perioperative rehabilitation in patients undergoing curative conventional colonic resection for cancer has not yet been studied in a multicenter setting. In 2005, a nationwide quality assurance program was initiated in Germany in an unselected patient population. METHODS: The prospective multicenter data collection includes patients from 24 German hospitals. All hospitals had established 'fast-track' rehabilitation as the standard perioperative treatment in elective colonic resection, and all patients entered the registry. RESULTS: 748 of 2,047 fast-track patients (36.5%) underwent open resection of colonic cancer. The median age of the 380 female and 368 male patients was 71 (26-96) years. Compliance was high for epidural analgesia (89%), systemic basic nonopioid analgesia (93%), 'restrictive' intraoperative intravenous fluids (81%), oral feeding (73%) and enforced mobilization (84%) on the day of surgery. Surgical complications were diagnosed in 20%, general morbidity occurred in only 13% of all patients, and 3 patients (0.4%) died in the early postoperative period. Readmission within 30 days of discharge was necessary in 27 patients (4%). CONCLUSIONS: Compliance with fast-track measures was high, and general morbidity was low in a population of patients undergoing multimodal perioperative rehabilitation for conventional colonic cancer resection.
Subject(s)
Colectomy/rehabilitation , Colonic Neoplasms/surgery , Quality Assurance, Health Care , Registries , Adult , Aged , Aged, 80 and over , Colectomy/standards , Elective Surgical Procedures/rehabilitation , Elective Surgical Procedures/standards , Female , Germany , Humans , Male , Middle Aged , Perioperative Care , Prospective StudiesABSTRACT
The risks and benefits of surgery for colorectal cancer in old patients have not been unequivocally defined. The present investigation was carried out in 309 hospitals as a prospective multicenter study. In the period between 1 January 2000 and 31 December 2001, a total of 19,080 patients were recruited for the study; 16,142 (84.6%) patients were younger than 80 years (<80) and 2932 (15.4%) were 80 years and older (> or =80). Significant differences between the age groups were observed for general postoperative complications (22.3% for <80 years; 33.9% for > or =80). Specific postoperative complications were identical in both groups. Overall, significantly elevated morbidity and mortality rates were found with increasing age (morbidity: 33.9% vs. 43.5%; mortality: 2.6% vs. 8.0%). The distribution of tumor stages revealed a significantly higher percentage of locally advanced tumors in the older age group (stage II: 28.0% vs. 34.4%). In contrast, no increase in metastasizing tumors was found in the older age group (stage IV: 17.4% vs. 14.1%). Logistic regression showed that, in concert with a number of other parameters, age is a significant influencing factor on postoperative morbidity and mortality. The increase in postoperative morbidity and mortality rates associated with aging is a result of the increase in general postoperative complications, in particular, pneumonia and cardiovascular complications. Age as such does not represent a contraindication for surgical treatment. The short-term outcome and quality of life are of overriding importance for the geriatric patient.