Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial).

BACKGROUND: The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. METHODS: Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. RESULTS: Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. CONCLUSION: Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. REGISTRATION NUMBER: NCT03445936 (http://www.clinicaltrials.gov).

Synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial.

BACKGROUND: Incisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. METHODS: The Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months' follow-up period. RESULTS: Of 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90). CONCLUSIONS: Both a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months' follow-up.

Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh: The Chimney Randomized Clinical Trial.

Importance: Prophylactic placement of a mesh has been suggested to prevent parastomal hernia. Evidence to support this practice is contradictory. Objective: To determine whether funnel-shaped permanent synthetic parastomal mesh is effective and safe in parastomal hernia prevention. Design, Setting, and Participants: The Chimney Trial was a randomized single-blinded multicenter trial conducted in 4 hospitals in Finland and 1 in Sweden from February 2019 and September 2021. Of 439 patients with rectal adenocarcinoma undergoing either laparoscopic or robotic-assisted abdominoperineal resection or the Hartmann procedure, 143 were enrolled in the trial, 135 received their allocated intervention, and 121 were analyzed at 12-month follow-up. Data were analyzed from December 2023 to May 2024. Intervention: In the intervention group, a permanent colostomy was created with a funnel-shaped intraperitoneal mesh and compared to a control group with a stoma without the mesh. Main Outcome and Measure: The primary end point was the incidence of computed tomography (CT)-confirmed parastomal hernia 12 months after surgery. Results: There were 68 patients (mean [SD] age, 68.7 [11.6] years; 36 [53% male and 32 [47%] female) who received the intended allocation in the mesh group and 67 (mean [SD] age, 66.4 [11.7] years; 48 [72%] male and 19 [28%] female) who received the intended allocation in the control group. CT scans were available for 58 patients in the mesh group and 59 patients in the control group at the 12-month follow-up. CT scans confirmed parastomal hernia in 6 of 58 patients (10%) in the mesh group compared to 22 of 59 patients (37%) in the control group (difference, 27%; 95% CI, 12-41; P < .001). Clinical parastomal hernia as a secondary outcome was recorded in 1 of 60 patients (2%) in the mesh group compared to 27 of 61 (43%) in the control group (difference, 41%; 95% CI, 29-55; P < .001). The number of patients with Clavien-Dindo class II ileus was 23 (35%) in the mesh group compared to 11 (17%) in the control group (difference, 18%; 95% CI, 3-32; P = .006). Only slight differences between the groups were detected in other stoma-related complications, readmissions, operative time, surgical site infections, reoperations, and quality of life. Conclusions and Relevance: In this study, funnel-shaped parastomal mesh prevented a significant number of parastomal hernias without predisposing patients to mesh- or stoma-related complications during 12-month follow-up. The results of this study suggest the funnel-shaped mesh is a feasible option to prevent parastomal hernia. Trial Registration: ClinicalTrials.gov Identifier: NCT03799939.

HIF-1α and VEGF are associated with disease progression in esophageal carcinoma.

BACKGROUND: Hypoxia inducible factor-1alpha (HIF-1α) is a transcription factor that regulates the transcription of genes associated with cell proliferation and angiogenesis. The purpose of this study is to clarify the correlation of HIF-1α protein expression with vascular endothelial growth factor (VEGF) and inducible (iNOS), endothelial (eNOS), and neuronal nitric oxide synthase (nNOS) expression in esophageal tumors. Additionally, vascular density in tumor tissue was assessed. MATERIALS AND METHODS: Eighty-eight esophageal carcinomas were analyzed by immunohistochemistry in paraffin embedded sections. RESULTS: HIF-1α immunoreactivity was seen in 71.2 % of the tumors. Squamous cell carcinomas expressed more often HIF-1α than adenocarcinomas (P = 0.009). HIF-1α immunoreactivity was associated with iNOS (P = 0.049), and iNOS positivity was also more commonly seen in squamous cell carcinomas than adenocarcinomas (P = 0.016). VEGF immunoreaction tended to associate with HIF-1α (P = 0.073) and iNOS (P = 0.08). ENOS did not associate with HIF-1α, but tended to associate with VEGF (P = 0.072). T1-T2 tumors were more often VEGF negative than T3-T4 tumors (P = 0.063). In the subgroup of 78 operatively treated ECs patients with HIF-1α positivity (> +) had more often distant metastases (P = 0.036). There was no association between iNOS, eNOS, nNOS, or VEGF, and microvessel density in tumor tissue, tumor marginal zone, or in peripheral tissue. CONCLUSIONS: These results show that there is a link in expression between HIF-1α, iNOS, (eNOS), and VEGF in esophageal cancer. This is in line with the fact of HIF-1α's function as a transcriptional factor for these angiogenic factors. Results also show that squamous cell and adenocarcinomas differ in their expression of HIF-1α and iNOS. VEGF appear to have association with depth of invasion in esophageal carcinomas. In our material HIF-1α positivity was associated with distant metastases, but not with patient survival.

Chimney Trial: study protocol for a randomized controlled trial.

BACKGROUND: Parastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. In previous studies, retromuscular keyhole mesh placement has been the most-used technique for PSH prevention but results have been controversial. Additionally, surgical treatment of PSHs is associated with a high rate of complications and recurrences. Therefore, it is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs. METHODS/DESIGN: The Chimney Trial is a Nordic, prospective, randomized controlled, multicenter trial designed to compare the feasibility and the potential benefits of specifically designed, intra-abdominal onlay mesh (DynaMesh®-Parastomal, FEG Textiltechnik GmbH, Aachen, Germany) against controls with permanent colostomy without mesh. The primary outcome of the Chimney Trial is the incidence of a PSH detected by a computerized tomography (CT) scan at 12-month follow-up. Secondary outcomes are the rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs. For each group, 102 patients were enrolled at attending hospitals and randomized at a ratio of 1:1 by browser-based software to receive a preventive mesh or a conventional colostomy without a mesh. Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. DISCUSSION: The Chimney Trial aims to provide level-I evidence on PSH prevention. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03799939. Registered on 10 January 2019.

Persuasive speech in multi-professional change facilitation meetings.

PURPOSE: The purpose of this paper is to describe persuasive speech and discourses in multi-professional organizational change facilitation meetings at a hospital through rhetorical discourse analysis. Previous research has often considered organizational change to be a managerial issue, with other employees given the rather passive role of implementators. This study takes an alternative approach in assuming that organizational change could benefit by involving those who are most familiar with the tasks to be changed. DESIGN/METHODOLOGY/APPROACH: The study employed a qualitative, case study approach and focused on the construction of a hospitalist model within multi-professional change facilitation meetings. Eight videos of these multi-professional change facilitation meetings - which occurred between January and September 2017 - were observed and the material was analyzed by rhetorical discourse analysis. An average of 10-20 actors from different professional groups participated in the meetings. The change actors comprised physicians, nursing staff and nursing managers, along with a secretary and hospitalist. The meetings were conducted by a change facilitator. FINDINGS: The persuasive speech in the analyzed organizational change meetings occurred within five distinct discourses: constructing the change together, positive feedback, strategic change in speech, patient perspective and driving change. The content of these discourses revealed topics that are relevant to persuading members of healthcare organizations to adopt a planned change. ORIGINALITY/VALUE: The presented research provides new knowledge about how persuasive speech is used in organizational change and describes the discourses in which persuasive speech is used in a healthcare context.

Preloop trial: study protocol for a randomized controlled trial.

BACKGROUND: A temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However, as 44% of incisional site hernias need further repair after stoma closure, attention has increasingly been paid to the use of mesh. Research on the prevention of these hernias is scarce, and no studies comparing different meshes exist. METHOD/DESIGN: The Preloop trial (Clinical Trials NCT03445936) is a prospective, randomized, controlled, multicenter trial to compare synthetic mesh (Parietene Macro™, Medtronic, Minneapolis, MN, USA) and biological implants (Permacol™, Medtronic) at a retromuscular sublay position for the prevention of incisional site hernias after loop-ileostomy closure. The main endpoints in this trial are infections at 30-day follow-up and the incidence of hernias clinically or on CT scan at 10 months after closure of the stoma. The secondary endpoints are other complications within 30 days of surgery graded with the Clavien-Dindo classification, reoperation rate, operating time, length of stay, quality of life measured with RAND-36, and incidence of hernia over a 5-year follow-up period. A total of 100 patients will be randomized in a 1:1 ratio. DISCUSSION: This is a pilot trial that will be undertaken to provide some novel evidence on the safety profile and efficiency of both synthetic mesh and biological implants for the prevention of incisional hernias after closure by temporary loop ileostomy. The hypothesis is that synthetic mesh is economical but equally safe and at least as effective as biological implants in hernia prevention and in contaminated surgical sites. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03445936 . Registered on 7 February 2018.

Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.

We evaluated the 3-year outcome of a series of patients with primary varicose veins who were randomized to radiofrequency endovenous obliteration vs. stripping of the long saphenous vein (LSV). Twenty-eight patients were included in the study: 15 were randomized to the radiofrequency endovenous obliteration procedure and 13 to LSV stripping. At 3-year follow-up, five patients (33.3%) of the endovenous group had recurrent or residual varices and in three of them a reflux in the thigh veins was detected. None of the primarily occluded LSV segments was recanalized. In the stripping group, three patients (23.1%, p = 0.68) showed varicosities at clinical and duplex examinations. In one patient, a patent duplicate LSV trunk was detected. In the remaining two patients, no reflux in the thigh region was detected. According to the present results, radiofrequency endovenous obliteration of the LSV is associated with somewhat poorer short-term results compared with the stripping operation.

Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.

OBJECTIVE: The aim of this randomized study was to compare a new method of endovenous saphenous vein obliteration (Closure System, VNUS Medical Technologies, Inc, Sunnyvale, Calif) with the conventional stripping operation in terms of short-term recovery and costs. METHODS: Twenty-eight selected patients for operative treatment of primary greater saphenous vein tributary varicose veins were randomly assigned to endovenous obliteration (n = 15) or stripping operation (n = 13). Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day. The length of sick leave was determined. The RAND-36 health survey was used to assess the patient health-related quality of life. The patient conditions were controlled 7 to 8 weeks after surgery, and patients underwent examination with duplex ultrasonography. The comparison of costs included both direct medical costs and costs resulting from lost of productivity of the patients. Costs that were similar in the study groups were not considered in the analysis. RESULTS: All operations were successful, and the complication rates were similar in the two groups. Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group (at rest: 0.7, standard deviation [SD] 0.5, versus 1.7, SD 1.3, P =.017; on standing: 1.3, SD 0.7, versus 2.6, SD 1.9, P =.026; on walking: 1.8, SD 0.8, versus 3.0, SD 1.8, P =.036; with t test). The sick leaves were significantly shorter in the endovenous obliteration group (6.5 days, SD 3.3 days, versus 15.6 days, SD 6.0 days; 95% CI, 5.4 to 12.9; P <.001, with t test). Physical function was also restored faster in the endovenous obliteration group. The estimated annual investment costs of the closure operation were US $3360. The other direct medical costs of the Closure operation were about $850, and those of the conventional treatment were $360. With inclusion of the value of the lost working days, the Closure treatment was cost-saving for society, and when 40% of the patients are retired (or 60% of the productivity loss was included), the Closure procedure became cost-saving at a level of 43 operations per year. CONCLUSION: Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for society, especially among employed patients. Because the procedure is also associated with shorter convalescence, this new method may potentially replace conventional varicose vein surgery.

Endovenous obliteration with radiofrequency-resistive heating for greater saphenous vein insufficiency: a feasibility study.

PURPOSE: To assess the feasibility, safety, and clinical utility of ultrasound (US)- and fluoroscopy-guided endovenous saphenous vein obliteration with radiofrequency (RF)-resistive heating in the treatment of primary venous insufficiency. MATERIALS AND METHODS: Thirty legs of 27 patients with mild to moderate varicose veins and primary greater saphenous vein (GSV) insufficiency diagnosed with duplex US were treated. An endovenous catheter was inserted via US-guided percutaneous puncture or a skin incision. Fluoroscopy and US were used to locate the electrodes at the saphenofemoral junction. GSVs were occluded with RF-resistive heating. Local phlebectomies or sclerotherapy were performed in all procedures to treat varicose veins and teleangiectases. Persistence of vein occlusion and complications potentially attributable to endovenous treatment were assessed at 1 week, 6 weeks, 3 months, 6 months, and 1 year. RESULTS: The mean follow-up time was 9.6 months (SD, 3.8 mo). By the time of the last follow-up visit, occlusion of the treated segment of the GSV had been achieved in 22 legs (73.3%). Persisting patency or recanalization of the GSV was detected in eight legs (26.7%). One patient (3.3%) had varicosity-related symptoms, and three treated legs (10%) had recurrent or new varicosities. Postoperative complications included saphenous nerve paresthesia in three legs (10%) and thermal skin injury in one limb (3.3%). CONCLUSION: Endovenous obliteration employing RF-resistive heating is a relatively safe and promising minimally invasive technique for the treatment of primary GSV insufficiency.

Increased postoperative concentrations of tenascin-C in wound fluid.

BACKGROUND: Tenascin-C (Tn-C) is the most studied member of a family comprising large oligomeric glycoproteins in the extracellular matrix. The function of Tn-C still is unclear, and the levels of Tn-C in human wound fluid have not been studied. METHODS: The participants in this study were 24 patients referred for elective major gastrointestinal surgery. Concentrations of Tn-C and procollagen propeptides type 1 and type 3 in serum and wound fluid were measured after surgery. RESULTS: In wound fluid, Tn-C was present on postoperative day 1, and the concentration increased from day 5 up to day 7. CONCLUSIONS: The concentration of Tn-C increases postoperatively in wound fluid. The concentration of Tn-C in wound fluid is markedly higher than that of serum. The differences in expression between Tn-C and the procollagen propeptides may reflect different tasks of these extracellular matrix proteins.