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.

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.