Prophylactic slowly resorbable mesh in midline laparotomy to limit incisional hernia incidence: the prospective 'Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS)' cohort study protocol.

Background: Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh ("investigational device"). However, the effectiveness of this mesh in IH prevention has not been proved. Methods: The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life. Discussion: Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.

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.

Ventralex™ ST Hernia Patch Repair for Small Umbilical Hernia is Safe and Effective: A Retrospective Cohort Study.

Background: Hernia patches for umbilical hernia repair have gained popularity due to their short operation time and ease of use. However, up to 10% re-operation and 8% recurrence rates at 2-year follow-up have been published. This retrospective cohort study presents the long-term results of the hernia patch technique for umbilical hernia repair. Methods: All adult patients who underwent a primary umbilical hernia repair at Oulu University Hospital hernia surgery units during 2014-2018 were included in the study. The primary outcome measure was recurrence rate. Secondary outcomes were complications and re-operation rate. Results: A total of 619 elective primary umbilical hernia repairs were performed during 2014-2018. The major technique used was Ventralex™ ST hernia patch repair (79.0%, 488/619) for small hernias with a mean width of 1.8 (SD 0.79) cm. Most of the patches (84.7%, 414/488) were placed in the preperitoneal space. Hernia recurrence rate of patient operated on using Ventralex™ ST hernia patch was 2.5% (12/488) during a mean follow-up time of 68 (SD 16, 43-98) months. Re-operation rate for another reason than recurrence was 1.6% (8/488). Clavien-Dindo complications ≥3 occurred in 4.1% (20/488) of cases and surgical site infection rate was 3.3% (16/488). Conclusion: Umbilical hernia repair using a Ventralex™ ST hernia patch placed in preperitoneal space have acceptable results in terms of recurrence and re-operations in this cohort study.

Perioperative oral nutritional support for patients diagnosed with primary colon adenocarcinoma undergoing radical surgical procedures -Peri-Nutri Trial: study protocol for a randomized controlled trial.

BACKGROUND: Colon cancer is one of the most common cancers in Finland and worldwide. Cancer-related malnutrition is a well-known risk factor for increased morbidity and mortality after surgery, and it is associated with complications and longer hospitalizations. There are no established recommendations on how to improve the nutritional status of colon cancer patients´ during the perioperative phase. Administration of simple oral nutritional supplements has been suggested to reduce complication rates, but evidence to support this practice is scarce. METHODS: The Peri-Nutri trial is a prospective, multicenter, randomized, controlled trial. Its primary endpoint is to evaluate whether perioperative oral nutritional support (ONS) decreases the number of complications during the 30-day follow-up after surgery. Secondary endpoints are to study the effect of ONS on quality of life after surgery, length of stay in institutional care, 90-day mortality rate, five-year disease-free survival and overall survival. The patients with a Nutritional risk screening 2002 (NRS-2002) questionnaire result between 2 and 5 (≥ 3 are classified at risk of malnutrition) will be randomized (1:1 ratio) into either the intervention or control group. The intervention group will receive preoperative ONS two weeks before the operation, and nutritional support will continue 10 days after the operation. The control group will not receive ONS. A total of 318 patients will be randomized into two groups and patients are followed five years. DISCUSSION: Peri-Nutri study evaluate the impact of ONS to short-term and long-term postoperative morbidity and mortality rates of colon cancer patients undergoing curative surgery. If ONS will decrease patients´ morbidity and mortality, that has a huge impact on patients´ quality of life and also to financial cost. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03863236 , Registered 25 February 2019.

Case control study investigating the clinical utility of NPWT in the perineal region following abdominoperineal resection for rectal adenocarcinoma: a single center study.

BACKGROUND: Perineal wound complications are common after abdominoperineal resection (APR) for rectal adenocarcinoma. Delayed wound healing may postpone postoperative adjuvant therapy and, therefore, lead to a worse survival rate. Negative-pressure wound therapy (NPWT) has been suggested to improve healing, but research on this subject is limited. METHODS: The aim of this study was to assess whether NPWT reduces surgical site infections (SSI) after APR for rectal adenocarcinoma when the closure is performed with a biological mesh and a local flap. A total of 21 consecutive patients had an NPWT device (Avelle, Convatec™) applied to the perineal wound. The study patients were compared to a historical cohort in a case-control setting in relation to age, body mass index, tumor stage, and length of neoadjuvant radiotherapy. The primary outcome was the surgical site infection rate. The secondary outcomes were the wound complication rate, the severity of wound complications measured by the Clavien-Dindo classification, length of hospital stay, and surgical revision rate. RESULTS: The SSI rate was 33% (7/21) in the NPWT group and 48% (10/21) in the control group, p = 0.55. The overall wound complication rate was 62% (13/21) in NPWT patients and 67% (14/21) in the control group, p > 0.90. The length of hospital stay was 15 days in the NPWT group and 13 in the control group, p = 0.34. The wound severity according to the Clavien-Dindo classification was 3b in 29% (6/21) of the NPWT group and in 38% (8/21) of the control group. A surgical revision had to be performed in 29% (6/21) of the cases in the NPWT group and 38% (8/21) in the control group, p = 0.73. CONCLUSION: NPWT did not statistically decrease surgical site infections or reduce wound complication severity in perineal wounds after APR in this case-control study. The results may be explained by technical difficulties in applying NPWT in the perineum, especially in female patients. NPWT devices should be further developed to suit the perineal anatomy before their full effect can be assessed. Trial registration The study was registered as a prospective registry study (266/2018, registered 15th of November 2018).

Incidence of parastomal and incisional hernia following emergency surgery for Hinchey III-IV diverticulitis: A systematic review.

PURPOSE: The aim of this systematic review was to evaluate the risk of parastomal (PSH) and incisional hernias (IH) after emergency surgery for Hinchey III-IV diverticulitis, with comparison between the Hartmann procedure and other surgical techniques. METHODS: The Cochrane Library, Embase, PubMed (MEDLINE), Web of Science and Scopus databases were systematically searched. The primary endpoint was parastomal hernia incidence. The secondary endpoint was incisional hernia incidence. RESULTS: Five studies (four randomized controlled trials and one retrospective cohort) with a total of 699 patients were eligible for inclusion. The PSH rate was 15%-46% for Hartmann procedure, 0%-85% for primary anastomosis, 4% for resection, and 2% for laparoscopic lavage. The IH rates were 5%-38% for Hartmann procedure, 5%-27% for primary anastomosis, 9%-12% for primary resection, and 3%-11% for laparoscopic lavage. CONCLUSIONS: Both the parastomal and incisional hernia incidences are poorly evaluated and reported, and varied greatly between the studies.

Open versus robotic-assisted laparoscopic posterior component separation in complex abdominal wall repair.

BACKGROUND: Transversus abdominis release (TAR) is a surgical technique used in the treatment of complex ventral hernias. The aim of this study was to compare outcomes of open (oTAR) versus robotic-assisted (rTAR) posterior component separation by TAR. METHODS: Consecutive patients at two European hernia centres who underwent bilateral TAR were included. The primary endpoint was the duration of postoperative hospital stay. RESULTS: Data from 90 rTAR and 79 oTAR operations were evaluated. Patient demographics were similar between groups in terms of age, sex, BMI, and co-morbidities. There were more smokers, and hernias were larger in the oTAR group (width 8.7 cm versus 10.0 cm; P = 0.031, length 11.6 cm versus 14.1 cm; P = 0.005). Duration of postoperative hospital stay was significantly shorter in the rTAR group (3.4 days versus 6.9 days; P < 0.001). Short-term serious complications (Clavien-Dindo grade III and above) were more frequent (20.3 per cent versus 7.8 per cent; P = 0.018), and there were more surgical site infections (12.7 per cent versus 3.3 per cent; P = 0.010) in the oTAR group. During a median follow-up of 19 months in the rTAR group and 43 months in the oTAR group, reoperation (4.4 per cent versus 8.9 per cent; P = 0.245), and recurrence rates (5.6 per cent versus 5.1 per cent; P > 0.009) were similar. CONCLUSION: Patients with ventral incisional hernias who undergo bilateral rTAR had significantly shorter postoperative hospital stays and fewer short-term complications compared with patients undergoing bilateral oTAR.

Sarcopenia and Myosteatosis Are Associated with Neutrophil to Lymphocyte Ratio but Not Glasgow Prognostic Score in Colorectal Cancer Patients.

Cancer patients commonly present sarcopenia, myosteatosis, and systemic inflammation, which are risk factors of poor survival. In this study, sarcopenia and myosteatosis were defined from preoperative body computed tomography scans of 222 colorectal cancer (CRC) patients and analyzed in relation to tumor and patient characteristics, markers of systemic inflammation (modified Glasgow prognostic score (mGPS), neutrophil−lymphocyte ratio (NLR), serum levels of C-reactive protein (CRP), albumin, and 13 cytokines, and survival. Of the systemic inflammation markers, sarcopenia and/or myosteatosis associated with elevated NLR (p = 0.005) and low albumin levels (≤35 g/L) (p = 0.018), but not with mGPS or serum cytokine levels. In addition, myosteatosis was associated with a proximal tumor location (p = 0.039), serrated tumor subtype (p < 0.001), and severe comorbidities (p = 0.004). Multivariable analyses revealed that severe comorbidities and serrated histology were independent predictors of myosteatosis, and older age and elevated NLR were independent indicators of sarcopenia. Myosteatosis associated with shorter overall survival in univariable analysis (HR 1.959, 95% CI 1.24−3.10, p = 0.004) but not in multivariable analysis (p = 0.075). We conclude that sarcopenia and myosteatosis were associated with inflammatory marker NLR, but not with mGPS. Moreover, patients with serrated CRC may have an increased risk of myosteatosis. Myosteatosis or sarcopenia were not independent predictors of patient survival.

Prophylactic retrorectus mesh versus no mesh in midline emergency laparotomy closure for prevention of incisional hernia (PREEMER): study protocol for a multicentre, double-blinded, randomized controlled trial.

BACKGROUND: Despite the fact that emergency midline laparotomy is a risk factor for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published thus far. METHOD: The PREEMER trial (registration number NCT04311788) is a multicentre, patient- and assessor-blinded, randomized controlled trial to be conducted in six hospitals in Finland. A total of 244 patients will be randomized at a 1 : 1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small-stitch 4 : 1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incidence of incisional hernia 2 years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical-site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related reoperations within the 2- and 5-year follow-ups; the incidence of incisional hernia within the 5-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale and the PROMIS questionnaire within 30 days and 2 and 5 years from surgery. Additionally, health-economic explorative measures will be explored. CONCLUSION: The PREEMER trial will provide level 1 evidence on incisional hernia prevention in an emergency setting. REGISTRATION NUMBER: NCT04311788 (http://www.clinicaltrials.gov). Registered 7 March 2020.