Project description:BackgroundParastomal hernia (PH) is the most common complication after ostomy formation. Prophylactic mesh placement may be effective in reducing the rate of PH at the stoma site. The aims of this systematic review were to summarize the evidence with regard to the safety and effectiveness in comparison with the standard procedure without mesh placement and to identify important risk constellations.MethodA systematic literature search was performed in PubMed, EMBASE and the Cochrane library with no language or date restrictions. Randomized (RCTs) and non-randomized controlled trials (nRCTs) were included. The main outcomes of interest were PH (primary outcome) rate and stoma-related complications (secondary outcomes) such as stenosis or fistula. Statistical analysis included meta-analyses of pooled data and subgroup analyses.ResultsEleven trials (eight RCTs; three nRCTs) with a total of 755 patients were included. PH rate varied from 0% to 59% in the intervention and from 20% to 94% in the control group. RCTs showed a significant reduction of PH rate in the mesh group (OR 0.24; 95% CI 0.10 to 0.58, p = 0.034), whereas included nRCTs did not. No significant differences were observed in postoperative complication rates. Subgroup analyses showed superiority of non-absorbable meshes and sublay mesh positioning in open surgery.ConclusionProphylactic mesh placement is safe and reduces PH rate. A recommendation for prophylactic non-absorbable meshes in a sublay position can be made for patients undergoing open colorectal operations with end-ostomies. Further research endeavors should focus on patient-oriented outcomes, not only PH rate, with respect to tailored treatment in specific patient populations.
Project description:Purpose:Parastomal hernia is a common complication following a stoma and may cause leakage or incarceration. No optimal treatment has been established, and existing methods using mesh repair are associated with high recurrence rates and a considerable risk for short- and long-term complications including death. A double-layer intraperitoneal on-lay mesh (IPOM), the Parastomal Hernia Patch (BARD™), consisting of ePTFE and polypropylene, has been developed and tailored to avoid recurrence. To evaluate the safety of and recurrence rate using this mesh, a nonrandomised prospective multicentre study was performed. Method:Fifty patients requiring surgery for parastomal hernia were enrolled. Clinical examination and CT scan prior to surgery were performed. All patients were operated on using the Parastomal Hernia Patch (BARD). Postoperative follow-up at one month and one year was scheduled to detect complications and hernia recurrence. Results:The postoperative complication rate at one month was 15/50 (30%). The parastomal hernia recurrence rate at one year was 11/50 (22%). The reoperation rate at one month was 7/50 (14%), and further 5/50 (10%) patients were reoperated on during the following eleven months.
Project description:BackgroundParastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications.MethodsOne hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement.DiscussionThe PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh.Trial registrationThe PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018.
Project description:ObjectiveThe aim of this study was to determine whether parastomal hernia (PSH) rate can be reduced by using synthetic mesh in the sublay position when constructing permanent end colostomy. The secondary aim was to investigate possible side-effects of the mesh.BackgroundPrevention of PSH is important as it often causes discomfort and leakage from stoma dressing. Different methods of prevention have been tried, including several mesh techniques. The incidence of PSH is high; up to 78%.MethodsRandomized controlled double-blinded multicenter trial. Patients undergoing open colorectal surgery, including creation of a permanent end colostomy, were randomized into 2 groups, with and without mesh. A lightweight polypropylene mesh was placed around the colostomy in the sublay position. Follow up after 1 month and 1 year. Computerized tomography and clinical examination were used to detect PSH at the 1-year follow up. Data were analyzed on an intention-to-treat basis.ResultsAfter 1 year, 211 of 232 patients underwent clinical examination and 198 radiologic assessments. Operation time was 36 minutes longer in the mesh arm. No difference in rate of PSH was revealed in the analyses of clinical (P = 0.866) and radiologic (P = 0.748) data. There was no significant difference in perioperative complications.ConclusionsThe use of reinforcing mesh does not alter the rate of PSH. No difference in complication rate was seen between the 2 arms. Based on these results, the prophylactic use of mesh to prevent PSH cannot be recommended.
Project description:To compare short-term outcomes between prolapse repairs with and without mesh using a national data set. Mesh use in surgical treatment of pelvic organ prolapse has gained wide popularity. However, mesh complications have increased concomitantly with its use.Public Use File data were obtained for a 5% random national sample of female Medicare beneficiaries aged 65 years and older. Women who underwent prolapse surgery were identified using Current Procedural Terminology Coding System, Fourth Edition (CPT-4) codes. Because the code for mesh placement was effected in 2005, we separated patients into 3 cohorts as follows: those who underwent prolapse repairs from 1999 to 2000 (presumably without mesh), those who underwent repairs from 2007 to 2008 (presumably without mesh), and those with mesh (based on CPT-4 code 57267) from 2007 to 2008. One-year outcomes were identified using International Classification of Diseases, Ninth Revision diagnosis and procedure codes and CPT-4 procedure codes.A total of 9180 prolapse repairs without mesh were performed from 1999 to 2000, 7729 without mesh from 2007 to 2008, and 1804 prolapse repairs with mesh from 2007 to 2008. Prolapse reoperation within 1 year of surgery was higher in nonmesh vs mesh cohorts (6%-7% vs 4%, P <.02). Mesh removal rates were higher in mesh vs nonmesh group (4% vs 0%-1%, P <.001). Mesh use was associated with more dyspareunia, mesh-related complications, and urinary retention, even when controlling for concomitant sling.Mesh to treat pelvic organ prolapse and stress urinary incontinence was associated with a small decrease in early reoperation for prolapse. This decrease came at the expense of increased rates of pelvic pain, retention, mesh-related complications, and mesh removal.
Project description:Interventions: Mesh Intervention Procedure:
Subjects in this arm of the study will have mesh permanently implanted at the stoma site at the time of their surgery. The procedure duration will differ between patients depending on the circumstances of, and indications for, the surgery. The stoma formation will be performed as follows:
1. Dissect away a section of peritoneum and posterior rectus sheath on the side of the colostomy from the posterior aspect of the rectus abdominus muscle with the centre of the superior-inferior aspect of this area at the level of the marked colostomy trephine site.
2. Place a piece of 15cm x 15cm mesh in the space.
3. Secure the lateral corners of the mesh to the lateral abdominal wall musculature with a permanent suture.
4. Make the trephine at the marked site using a circular skin incision and deepen through abdominal wall fat to the fascia. Make a cruciate incision in the anterior rectus sheath, split the rectus abdominus muscle longitudinally.
5. Cut a circle in the centre of the mesh and the peritoneum of a size just adequate to allow easy passage of the colon through the mesh and then the abdominal wall.
6. Deliver the colon through the trephine site to the skin.
7. Close fascia.
8. Irrigate wound.
9. Close the midline wound skin.
10. Apply a dressing to the midline wound.
11. Mature the colostomy using dissolvable sutures.
12. Apply the colostomy bag.
Primary outcome(s): The formation of clinically-apparent parastomal herniae.
Assessment:
Clinical assessment of stoma site.[6 weeks and 6, 12, 36 and 120 months postoperatively.];The formation of radiologically-apparent parastomal herniae.
Assessment:
CT scan of abdomen[12, 36 and 120 months postoperatively.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy
Project description:BackgroundParastomal hernia after ileal conduit urinary diversion is an underestimated and undertreated clinical entity, which heavily impairs patients' quality of life due to symptoms of pain, leakage, application or skin problems. As for all gastrointestinal stomata the best surgical repair technique has yet to be determined. Thereby, surgery for ileal conduit parastomal hernias poses some specific perioperative challenges. This review aims to give an overview of current evidence on the surgical treatment of parastomal hernia after cystectomy and ileal conduit urinary diversion, and on the use of prophylactic mesh at index surgery in its prevention.MethodsA systematic review was performed according to PRISMA-guidelines. The electronic databases Embase, PubMed, Cochrane Library, and Web of Science were searched. Studies were included if they presented postoperative outcomes of patients undergoing surgical treatment of parastomal hernia at the ileal conduit site, irrespective of the technique used. A search was performed to identify additional studies on prophylactic mesh in the prevention of ileal conduit parastomal hernia, that were not identified by the initial search.ResultsEight retrospective case-series were included for analysis, reporting different surgical techniques. If reported, highest complication rate was 45%. Recurrence rates varied highly, ranging from 0 to 80%. Notably, lower recurrence rates were reported in studies with shorter follow-up. Overall, available data suggest significant morbidity after the surgical treatment of ileal conduit parastomal hernias. Data from five conference abstracts on the matter were retrieved, and systematically reported. Regarding prophylactic mesh in the prevention of ileal conduit parastomal hernia, 5 communications were identified. All of them used keyhole mesh in a retromuscular position, and reported on favorable results in the mesh group without an increase in mesh-related complications.ConclusionData on the surgical treatment of ileal conduit parastomal hernias and the use of prophylactic mesh in its prevention is scarce. Given the specific perioperative challenges and the paucity of reported results, more high-quality evidence is needed to determine the optimal treatment of this specific surgical problem. Initial results on the use of prophylactic mesh in the prevention of ileal conduit parastomal hernias seem promising.
Project description:Extrapleural pneumonectomy (EPP) is indicated in selected group of patients with pleural mesothelioma. Diaphragmatic reconstruction represents a part of this complex operation. We present the case of a late diaphragmatic gastric herniation through prosthetic material after EPP.
Project description:BackgroundParastomal hernia, common after stoma creation, negatively impacts patient quality of life. For patients with a permanent stoma, durable parastomal hernia repair remains a challenge, with few high-quality studies for guidance. An alternative to open retromuscular parastomal hernia repair with retromuscular "keyhole" mesh is the recent Sugarbaker modification. We aim to compare these two techniques in a head-to-head prospective study.MethodsThis is a registry-based randomized controlled trial designed to investigate whether the retromuscular Sugarbaker technique is superior to the retromuscular keyhole technique for parastomal hernia repair. The primary study endpoint is parastomal hernia recurrence at 2 years. Secondary endpoints include hospital length-of-stay, readmission, wound morbidity, mesh-related complications, re-operation, all 30-day morbidity, and patient-reported outcomes, including hernia-related quality of life, stoma-specific quality of life, pain, and decision regret.DiscussionBased on the post hoc analysis of a recent randomized controlled trial, we hypothesize that the retromuscular Sugarbaker technique will reduce parastomal hernia recurrence by 20% at 2 years compared to the retromuscular keyhole mesh technique. The results of this study may provide evidence-based guidance for surgeons repairing parastomal hernias.Trial registrationClinicalTrials.gov NCT03972553. Registered on 3 June 2019.