Laparoscopic incisional hernia repair does not seem to be a better procedure than the open anterior technique in terms of operative time, hospitalization, complications, pain or quality of life.
Hepatocyte transplantation (HT) has become an effective therapy for patients with metabolic inborn errors. We report the clinical outcome of four children with metabolic inborn errors that underwent HT, describing the cell infusion protocol and the metabolic outcome of transplanted patients. Cryopreserved hepatocytes were used as this allows scheduling of treatments. Functional competence (viability, cell attachment, major cytochrome P450 and UDP-glucuronosyltransferase 1A1 activities, and urea synthesis) and microbiological safety of cell batches were assessed prior to clinical use. Four pediatric patients with liver metabolic diseases [ornithine trans carbamylase (OTC) deficiency, Crigler-Najjar (CNI) syndrome, glycogen storage disease Ia (GSD-Ia), and tyrosinemia type I (TYR-I)] underwent HT. Indication for HT was based on severity of disease, deterioration of quality of life, and benefits for the patients, with the ultimate goal to improve their clinical status whenever liver transplantation (LT) was not indicated or to bridge LT. Cells were infused into the portal vein while monitoring portal flow. The protocol included antibiotic prophylaxis and immunosuppressant therapy. After HT, analytical data on the disease were obtained. The OTC-deficient patient showed a sustained decrease in plasma ammonia levels and increased urea production after HT. Further cell infusions could not be administered given a fatal nosocomial fungus sepsis 2 weeks after the last HT. The CNI and GSD-Ia patients improved their clinical status after HT. They displayed reduced serum bilirubin levels (by ca. 50%) and absence of hypoglycaemic episodes, respectively. In both cases, the HT contributed to stabilize their clinical status as LT was not indicated. In the infant with TYR-I, HT stabilized temporarily the biochemical parameters, resulting in the amelioration of his clinical status while diagnosis of the disease was unequivocally confirmed by full gene sequencing. In this patient, HT served as a bridge therapy to LT.
Complications in the T-tube group were less severe and required less aggressive treatment. The incidence of anastomotic strictures was higher in patients with no T-tube. We recommend conducting choledochocholedochostomy with a rubber T-tube during liver transplantation in risky anastomosis and when the bile duct diameter is less than 7 mm. This study is registered at http://www.clinicaltrials.gov: Clinical trial ID# NCT01546064.
Purpose
Long‐term extension of a previous randomized controlled clinical trial comparing open (OVHR) vs. laparoscopic (LVHR) ventral hernia repair, assessing recurrence, reoperation, mesh‐related complications and self‐reported quality of life with 10 years of follow‐up.
Methods
Eighty‐five patients were followed up to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index until recurrence, death or study completion, whichever was first. Recurrence, reoperation rates and death were estimated by intention to treat. Mesh‐related complications were only assessed in the LVHR group, excluding conversions (intraperitoneal onlay; n = 40). Quality of life, using the European Hernia Society Quality of Life score, was assessed in surviving non‐reoperated patients (n = 47).
Results
The incidence rates with 10 person‐years of follow‐up were 21.01% (CI 13.24–33.36) for recurrence, 11.92% (CI: 6.60–21.53) for reoperation and 24.88% (CI 16.81–36.82) for death. Sixty‐two percent of recurrences occurred within the first 2 years of follow‐up. No significant differences between arms were found in any of the outcomes analyzed. Incidence rate of intraperitoneal mesh complications with 10 person‐years of follow‐up was 6.15% (CI 1.99–19.09). The mean EuraHS‐QoL score with 13.8 years of mean follow‐up for living non‐reoperated patients was 6.63 (CI 4.50–8.78) over 90 possible points with no significant differences between arms.
Conclusion
In incisional ventral hernias with wall defects up to 15 cm wide, laparoscopic repair seems to be as safe and effective as open techniques, with no long‐term differences in recurrence and reoperation rates or global quality of life, although lack of statistical power does not allow definitive conclusions on equivalence between alternatives.
Trial registration number
ClinicalTrial.gov (NCT04192838).
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