Peristomal Mesh for Prophylaxis of Parastomal Hernia
HerniaThe study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair
Ventral HerniaTo compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial. All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia
Inguinal HerniaPrimary1 moreFor the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein
Inguinal HerniaThe aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences
Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.
Congenital Diaphragmatic HerniaFetal Surgery1 moreIsolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases. The risk for these can be predicted prenatally by the ultrasonographic measurement of the observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of pulmonary hypoplasia. Also position of the liver is predictive of outcome. The proposing consortium has developed a prenatal therapeutic approach, which consists of percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the balloon. Both procedures are performed percutaneously, there is now experience with more than 150 cases and it has been shown to be safe for the mother. We have witnessed an improvement of survival in fetuses with a predicted chance of survival of less than 30% (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation) to 55% on average. Also there is an apparent reduction in morbidity with the rate of bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than 40% in the same severity group. Further we have shown that results of FETO are predicted by LHR measurement prior to the procedure, so that better results can be expected in fetuses with larger lung size. Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%, irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation of the liver). When managed expectantly the estimated rate of postnatal survival is 55%. This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant management during pregnancy, both followed by standardized postnatal management increases survival or decrease oxygen dependency at 6 months of age. The balloon will be placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Inguinal HerniaWe compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.
Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years
Inguinal HerniaLaparoscopic techniques have been applied widely to the management of various common pediatric surgical diseases. Current evidence lacks sufficient quality to justify the widespread adoption of the laparoscopic approach to the repair of inguinal hernias within children. It is important to critically evaluate the efficiency and the potential risks of these new techniques before they can supplant open techniques as the treatment modality of choice. Numerous large case series of laparoscopic inguinal hernia repair have been reported with average length of stay, complication rates, recurrence rates and pain management scores that mirror those of open inguinal hernia repair. Only one randomized controlled trial has been performed to compare the open versus laparoscopic technique which has not provided answers regarding the potential benefits on young infants. Benefits of an open approach in children includes a shorter operative time, while the laparoscopic procedure is associated with less pain and a better cosmetic result. This study will compare open versus laparoscopic repairs of inguinal hernias. The primary outcome variable will be total dose of acetaminophen administered postoperatively for pain management. Secondary outcome variables include 1) Incidence of intraoperative complications such as compromise of testicular vessels, perforation of abdominal viscera; 2) Short-term outcomes such as operative time, rate of conversion from open to laparoscopic procedure, requirement for reoperation within 30 days, wound infection, acute hydroceles and post-operative length of stay; 3) Long-term outcomes such as recurrent inguinal hernia, testicular atrophy and; 4) Cost of hospitalization will be compared between the open and laparoscopic groups. Comparisons will be made in two groups of patients- patients with 1) unilateral hernias and 2) bilateral hernias and will last for 2 years. 102 patients in the unilateral arm and 50 patients in the bilateral arm will be randomized to each treatment group and each subject will be followed for up to 12 months following the surgical intervention. Two study evaluations by telephone (in addition to a single outpatient clinic visit already required as part of standard post-operative care) will be required of each research subject and his/her parent/guardian. The telephone evaluations will occur at 3 and 12 months following surgery. The standard post-operative clinic visit is scheduled at 2 weeks following surgery.
Preperitoneal Versus Pre-trasversalis Hernia Repair
Direct Inguinal HerniaIndirect Inguinal HerniaChronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space to assess any differences in term of chronic pain and early and late complications
Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
Hiatal HerniaThis is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a preliminary study at the University of Washington. A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40% within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold. The mesh serves as a reinforcing material during the surgical repair. It is cut to the appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue. There are many different types of meshes available on the market, and vary in the degree of manageability, strength, and adherence. Although surgical meshes work on the same principal, the variance between materials may affect patient outcomes. There is evidence that a biologic mesh, specifically one derived from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically, this would prevent the possible complications associated with synthetic mesh including mesh erosion into the esophagus or stricture of the esophagus. There are some case series showing similar short-term results between the different biologic meshes, but there is no direct comparative data.
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia...
HerniaUmbilicalTo study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.