Background Parastomal hernia is a common stoma complication causing the patient considerable inconvenience. The patient becomes aware of a bulge around the stoma, but a bulge is not always a parastomal hernia and diagnostics must be performed to enable differential treatment. It is difficult to distinguish between a bulge and a hernia. Results based on clinical examination and computerised tomography (CT) in the supine position, have not been convincing. Three-dimensional intrastomal ultrasonography (3D US) is a novel technique shown to be promising in the assessment of stoma complaints. Two studies were performed to determine inter- and intra-observer reliability as well as the validity of 3D US as an alternative to CT when assessing stoma complaints. There are numerous options for the treatment of parastomal hernia, but none has been shown superior. In the recent decades the use of mesh in the repair of incisional and inguinal hernia has become routine. New materials must be evaluated as there are potential morbidity and even mortality risks with mesh repair. As recurrence of a parastomal hernia is an even greater challenge, the method of choice should have a low risk for recurrence. A prospective multicenter study was performed to evaluate safety and recurrence rate when using Parastomal Hernia Patch BARDTM (PHP), a mesh specially designed for parastomal hernia repair. A stoma has a profound impact on the patient´s daily life, both physical and psychological. A parastomal hernia with its associated risk for leakage and incarceration worsens the situation. Patient driven assessment of healthcare outcome is important if we are to improve medical care. A quality of life (QoL) survey was performed to assess the impact of parastomal bulging and hernia on the patient´s daily life. Methods Forty patients were investigated and the 3D US images were twice evaluated by two or three physicians to assess inter- and intra-observer reliability. Totally 20 patients with stoma complaints requiring surgery were examined with CT and 3D US prior to surgery. The findings were compared with the intraoperative findings – regarded as the true outcome. Fifty patients with parastomal hernia requiring surgery were enrolled from three hospitals. Patients were followed up one month and one year after repair using PHP. Patients still alive in 2008 who had been operated between1996 and 2004 for rectal cancer in Uppsala/Örebro-, Stockholm/Gotland-, and Northern Regions (986 patients) and registered in the Swedish Rectal Cancer Registry (SRCR) were invited to fill in four QoL questionnaires. Results Inter-observer agreement using 3D US reached 80% for the last 10 patients examined, with a kappa value of 0.70. Intra-observer agreement for two examiners was 80% and 95%. The learning curve levelled out at 30 patients. Both CT and 3D US showed high sensitivity and specificity when compared with intraoperative findings. After surgery for parastomal hernia with a PHP, the complication rate at one month was 30% and recurrence rate at one year was 22%. Twelve patients were reoperated within one year. In the QoL study, 31.5% of the patients with a stoma reported a bulging or a hernia. 11.7% had been operated for parastomal hernia. A hernia or a bulge gave rise to significantly more pain and impaired stoma function. Overall QoL was inferior in patients with a permanent stoma compared to a group without a stoma.

The aims of the studies was to evaluate the short and long term effects on the development of parastomal hernia and stoma complications of a prophylactic prosthetic mesh placed in a sublay position at the index operation.  Also the purpose was to validate a definition of parastomal hernia at clinical examination and a method and a definition of parastomal hernia at CT-scan. In the first two studies 27 patients were randomized to a conventional stoma or to a stoma with the addition of a partly absorbable low weight large pore mesh in sublay position. Patients were examined after one and five years.  After five years the rate of parastomal hernia was 80% with a conventional stoma and 14% with the addition of a mesh.  A prophylactic mesh did not increase the rate of complications. In the third study a prophylactic mesh was intended at stoma formation in 93 consecutive patients in routine surgery. In 75 patients provided with a mesh the rate of parastomal hernia after one year was 13%. Complication rates were not increased in 19 severely contaminated wounds. In the fourth study 27 patients with ostomies were examined by tree surgeons and parastomal hernia was defined as any protrusion in the vicinity of the stoma. CT-scans with patients examined in the supine and prone positions were assessed by three radiologists. Herniation was then defined as any intra abdominal content protruding beyond peritoneum or the presence of a hernia sac. Kappa was 0.85 for surgeons and 0.85 for radiologists with CT-scan in the prone position. Kappa was 0.80 for surgeons and radiologists collectively, with CT-scan in the prone position. Four parastomal hernias detected at CT-scan in the prone position could not be detected in the supine position. A parastomal hernia diagnosed at clinical examination was always detected at CT-scan in the prone position. Conclusions: A prophylactic mesh placed in a sublay position at the index operation reduces the rate of parastomal hernia without increasing the rate of complications. Parastomal hernia should at clinical examination be defined as any protrusion in the vicinity of the stoma with the patient straining in the supine and erect positions.  At CT-scan, with the patient examined in the prone position, herniation should be defined as any intra abdominal content protruding beyond peritoneum or the presence of a hernia sac. / Embargo, publiceras 2011-05-01