Standard Closure Research Articles

Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy

ObjectiveMidline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements. MethodsA prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit. ResultsGroups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks. ConclusionsZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy.

Purse-string closure technique reduces the incidence of incisional hernias following the reversal of temporary ileostomy.

The incidence of incisional hernia (IH) at ileostomy closure site has not been sufficiently evaluated. Temporary loop ileostomy is routinely used in patients after low anterior resection for rectal cancer. The goal of this study was to compare the IH rates of standard suture skin closure and purse-string skin closure techniques. Patients undergoing ileostomy reversal and follow-up CT scan at the University Hospital Frankfurt between January 2009 and December 2015 were retrospectively analyzed regarding IH and associated risk factors. Patients received either direct stitch skin closure (group DC) or purse-string skin closure (group PS). In total, 111 patients underwent ileostomy reversal in the aforementioned period. In 88 patients, a CT scan was performed 12-24months after ileostomy reversal for cancer follow-up. Median follow-up was 12months. Median time interval between ileostoma formation and closure was 12 (± 4 SD) weeks. In 19 of 88 patients (21.5%), an IH was detected. The incidence of IH detected by CT scan was significantly lower in the PS group (n = 7, 12.9%) compared to the DC group (n = 12, 35.2%, p = 0.017). This retrospective study shows an advantage of the purse-string skin closure technique in ileostomy reversals. The use of this technique for skin closure following ileostomy reversals is recommended to reduce the IH rates. Randomized controlled trials are needed to confirm these findings.

OIL PRICE REDUCTION IMPACTS ON THE IRANIAN ECONOMY

The aim of this study is to assess the impacts of oil price reduction on Iran’s economy. In order to simulate this shock, the global trade analysis project (GTAP) model with its data done by using. In the new created data aggregation, oil exporting in Iran and the rest of the world countries as economic new regions, ten new economic sectors have been created, among which the oil is introduced as one sector as well as five endowments. The standard economic closure was changed, and decline in world oil price was simulated in model as a policy shock. The results show that oil export revenue and the mineral commodity export earnings will decrease, but other production sectors’ exports will increase. The trade balance of Iran will be affected negatively and strongly. Also, oil and other services production decreased. In the production sectors’ market, the demand for labor, natural resources, and investment decreased dramatically, and the demand for land increased. Using equivalent variation (EV), changes in Iran’s welfare is high negative. Finally, deflation, reduction in value and quantity of GDP and changes in consumption combination from public to private sector are the other economic impacts of reduction in oil price on Iran’s economic. It is suggested that future studies are done using dynamic models and up-to-date data. In addition, policy makers need to rebound internationally and within OPEC to raise oil prices.

Hughes Abdominal Repair Trial (HART)—abdominal wall closure techniques to reduce the incidence of incisional hernias: feasibility trial for a multicentre, pragmatic, randomised controlled trial

ObjectivesIncisional hernias are common complications of midline abdominal closure. The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single...

McCall Culdoplasty during Total Laparoscopic Hysterectomy: A Pilot Randomized Controlled Trial

Study ObjectiveTo assess the feasibility and safety of a McCall culdoplasty at the time of total laparoscopic hysterectomy and to evaluate the differences in the total vaginal length, vaginal apex during Valsalva, and sexual function 12 months after McCall culdoplasty compared with standard cuff closure. DesignA pilot randomized controlled, single-masked trial (Canadian Task Force classification I). SettingAn academic tertiary care hospital. PatientsWomen undergoing total laparoscopic hysterectomy for benign indications from June 2013 to December 2013. InterventionsWomen were randomized (1:1) to McCall culdoplasty followed by standard cuff closure versus standard cuff closure. Patients underwent Pelvic Organ Prolapse Quantification examination and completed the Female Sexual Function Index immediately before surgery and at 6 months and 12 months postoperatively. The primary outcome was the operative time. Secondary outcomes included estimated blood loss, complications, total vaginal length, vaginal apex during Valsalva, and sexual function. Measurements and Main ResultsThis study included 50 patients. The groups were similar in terms of preoperative and surgical characteristics. The operative time did not differ between the groups. The estimated blood loss and complications were also similar. The loss to follow-up was similar in both groups. Changes in the total vaginal length, vaginal apex during Valsalva, sexual function, and pain with intercourse did not differ between the groups. ConclusionIn this pilot study, the addition of McCall culdoplasty to standard cuff closure during total laparoscopic hysterectomy was not associated with an increase in operative time, estimated blood loss, or surgical complications. No differences in the total vaginal length or vaginal apex during Valsalva were observed at the 12-month follow-up. There were no differences in sexual dysfunction or dyspareunia. Given the well-established risk reduction for the development of apical prolapse with McCall culdoplasty during vaginal hysterectomy, this procedure may be a feasible and safe addition to total laparoscopic hysterectomy.

Preliminary Study of PGA Fabric for Seromas at Latissimus Dorsi Flap Donor Sites.

Background:Seroma formation is a major complication following latissimus dorsi (LD) flap transfer for breast reconstruction. We implanted a nonwoven polyglycolic acid (PGA) fabric—a biodegradable polymer—in the LD flap donor site and examined its effect on postoperative seroma formation and resolution in a comparative study on 38 patients undergoing primary 1-stage breast reconstruction by LD flap.Method:A PGA treatment group had a PGA fabric placed in the donor wound (PGA group, n = 20), whereas a second group was treated with standard donor site closure (control group, n = 18). The incidence of seromas was comparable between the groups.Result:There was a significant reduction in aspiration volume by needle aspiration after drain removal (P < 0.05) and in the time until seroma resolution (P < 0.01) in the PGA group compared with the control group.Conclusion:These results indicate that application of PGA at the LD donor site is useful in controlling postoperative seromas.

Modified Hysterotomy Closure Technique for Open Fetal Surgery

Objective: We reviewed our experience with open fetal surgical myelomeningocele repair to assess the efficacy of a new modification of the hysterotomy closure technique regarding hysterotomy complication rates at the time of cesarean delivery. Methods: A modification of the standard hysterotomy closure was performed on all patients undergoing prenatal myelomeningocele repair. The closure consisted of an interrupted full-thickness #0 polydioxanone (PDS) retention suture as well as a running #0 PDS suture to re-approximate the myometrial edges, and the modification was a third imbricating layer resulting in serosal-to-serosal apposition. A standard omental patch was placed per our routine. Both operative reports and verbal descriptions of hysterotomy from delivering obstetricians were reviewed. Results: A total of 49 patients underwent prenatal repair of myelomeningocele, 43 having adequate follow-up for evaluation. Of those, 95.4% had completely intact hysterotomy closures, with only 1 partial dehiscence (2.3%) and 1 thinned scar (2.3%). There were no instances of uterine rupture. Discussion: In patients undergoing this modified hysterotomy closure technique, a much lower than expected complication rate was observed. This simple modified closure technique may improve hysterotomy healing and reduce obstetric morbidity.

Meta-analysis of randomised trials comparing the use of prophylactic mesh to standard midline closure in the reduction of incisional herniae.

PubMed, clinictrials.gov.uk, and the Cochrane database were searched for randomised controlled trials comparing closure of the abdomen after laparotomy using a prophylactic mesh with suture closure. A meta-analysis was then performed. The primary outcome was the occurrence of IH. Eight studies were identified for inclusion in the meta-analysis with a total of 727 patients. There was a significant reduction in the occurrence of IH in the mesh group vs. the suture repair group, OR 0.14 (95% CI 0.07-0.27). There was a significant increase in the number of seromas in the mesh group vs. the suture repair group, OR 1.73 (95% CI 1.04-2.87). There was also a significant increase in operative time in the mesh group vs. the suture repair group SMD 0.24 (95% CI 0.00-0.48). This meta-analysis found a reduction in the occurrence of IH after a laparotomy when a prophylactic mesh is used versus a suture repair. The majority of patients included in the studies were deemed to be at high risk of IH. There appears to be sufficient evidence to recommend the use of a prophylactic mesh during laparotomy in high-risk patients.

Leucocyte- and platelet-rich fibrin (L-PRF) as a regenerative medicine strategy for the treatment of refractory leg ulcers: a prospective cohort study

Chronic wounds (VLU: venous leg ulcer, DFU: diabetic foot ulcer, PU: pressure ulcer, or complex wounds) affect a significant proportion of the population. Despite appropriate standard wound care, such ulcers unfortunately may remain open for months or even years. The use of leukocyte- and platelet-rich fibrin (L-PRF) to cure skin ulcers is a simple and inexpensive method, widely used in some countries but unknown or neglected in most others. This auto-controlled prospective cohort study explored and quantified accurately for the first time the adjunctive benefits of topical applications of L-PRF in the management of such refractory ulcers in a diverse group of patients. Forty-four consecutive patients with VLUs (n = 28, 32 wounds: 17 ≤ 10 cm2 and 15 > 10 cm2), DPUs (n = 9, 10 wounds), PUs (n = 5), or complex wounds (n = 2), all refractory to standard treatment for ≥3 months, received a weekly application of L-PRF membranes. L-PRF was prepared following the original L-PRF method developed more than 15 years ago (400g, 12 minutes) using the Intra-Spin L-PRF centrifuge/system and the XPression box kit (Intra-Lock, Boca Raton, FL, USA; the only CE/FDA cleared system for the preparation of L-PRF). Changes in wound area were recorded longitudinally via digital planimetry. Adverse events and pain levels were also registered. All wounds showed significant improvements after the L-PRF therapy. All VLUs ≤ 10 cm2, all DFUs, as well as the two complex wounds showed full closure within a 3-month period. All wounds of patients with VLUs > 10 cm2 who continued therapy (10 wounds) could be closed, whereas in the five patients who discontinued therapy improvement of wound size was observed. Two out of the five PUs were closed, with improvement in the remaining three patients who again interrupted therapy (surface evolution from 7.35 ± 4.31 cm2 to 5.78 ± 3.81 cm2). No adverse events were observed. A topical application of L-PRF on chronic ulcers, recalcitrant to standard wound care, promotes healing and wound closure in all patients following the treatment. This new therapy is simple, safe and inexpensive, and should be considered a relevant therapeutic option for all refractory skin ulcers.

Suture Choice in Lumbar Dural Closure Contributes to Variation in Leak Pressures: Experimental Model.

Open-label laboratory investigational study; non-animal surgical simulation. The authors perform a comparison of dural closure strength in a durotomy simulator across 2 different suture materials. Incidental durotomy leading to persistent cerebrospinal fluid leak adds considerable morbidity to spinal procedures, often complicating routine elective lumbar spinal procedures. Using an experimental durotomy simulation, the authors compare the strength of closure using Gore-Tex with other suture types and sizes, using various closure techniques. A comparison of dural closures was performed through an analysis of the peak pressure at which leakage occurred from a standardized durotomy closure in an established cerebrospinal fluid repair model with a premade L3 laminectomy. Nurolon was compared with Gore-Tex sutures sizes (for Gore-Tex, CV-6/5-0 and CV-5/4-0 was compared with Nurolon 4-0, 5-0, and 6-0). Thirty-six trials were performed with Nurolon 4-0, 5-0, and 6-0, whereas 21 trials were performed for 4-0 and 5-0 Gore-Tex. The mean peak pressure at which fluid leakage was observed was 21 cm H2O for Nurolon and 34 cm H2O for Gore-Tex. Irrespective of suture choice, all trials were grouped by closure technique: running suture, locked continuous, and interrupted suture. No significant difference was noted between the groups. For each of the 3 trials groups by closure technique, running, locked continuous, and interrupted, Gore-Tex closures had a significantly higher peak pressure to failure. Interrupted Gore-Tex was significantly higher than Interrupted Nurolon (P=0.007), running Gore-Tex was significantly higher than running Nurolon (P=0.034), and locked Gore-Tex was significantly higher than locked Nurolon (P=0.014). Durotomy closure in the lumbar spine with Gore-Tex suture may be a reasonable option for providing a watertight closure. In this laboratory study, Gore-Tex suture provided watertight dural closures that withstood higher peak pressures.

CLOSURE OPERATORS, FRAMES AND NEATEST REPRESENTATIONS

Given a poset $P$ and a standard closure operator $\unicode[STIX]{x1D6E4}:{\wp}(P)\rightarrow {\wp}(P)$, we give a necessary and sufficient condition for the lattice of $\unicode[STIX]{x1D6E4}$-closed sets of ${\wp}(P)$ to be a frame in terms of the recursive construction of the $\unicode[STIX]{x1D6E4}$-closure of sets. We use this condition to show that, given a set ${\mathcal{U}}$ of distinguished joins from $P$, the lattice of ${\mathcal{U}}$-ideals of $P$ fails to be a frame if and only if it fails to be $\unicode[STIX]{x1D70E}$-distributive, with $\unicode[STIX]{x1D70E}$ depending on the cardinalities of sets in ${\mathcal{U}}$. From this we deduce that if a poset has the property that whenever $a\wedge (b\vee c)$ is defined for $a,b,c\in P$ it is necessarily equal to $(a\wedge b)\vee (a\wedge c)$, then it has an $(\unicode[STIX]{x1D714},3)$-representation.

Sternocleidomastoid flap augmentation of the pharyngeal closure after total laryngectomy.

The objective of the study was to evaluate the effect of sternocleidomastoid (SCM) flap augmentation of the pharyngeal closure after total laryngectomy on the incidence of pharyngocutaneous fistula (PCF). Thirty patients with T4a laryngeal carcinoma and none of them receiving primary radiotherapy previously were divided into two equal groups. Group A patients had SCM flap augmentation of the pharyngeal closure after total laryngectomy. Group B patients had the standard pharyngeal closure without augmentation. Both groups were followed up for 30days postoperatively for the development of PCF. The use of the SCM added about extra 15min to the surgical procedure in all patients (p<0.001). The shape of the suture line of the neopharynx was horizontal in 14 patients (7 in each group) while it was T-shaped in the remaining 16 (8 in each group). Neck dissection was done in all patients except only two patients who previously had the neck dissection done in combination with partial laryngectomy. Three patients in each group developed PCF either early (10days or less postoperatively) or late (more than 10days but less than 30days postoperatively). There was no statistically significant difference in the length of hospital stay between the two groups. The use of SCM flap did not reduce the incidence of PCF after total laryngectomy.

On nonhydrostatic coastal model simulations of shear instabilities in a stratified shear flow at high Reynolds number

AbstractThe nonhydrostatic surface and terrain‐following coastal model NHWAVE is utilized to simulate a continually forced stratified shear flow in a straight channel, which is a generic problem to test the existing nonhydrostatic coastal models' capability in resolving shear instabilities in the field scale. The resolved shear instabilities in the shear layer has a Reynolds number of about 1.4 × 106, which is comparable to field observed value. Using the standard Smagorinsky closure with a grid size close to the Ozmidov length scale, simulation results show that the resolved energy cascade exceeds 1 order of magnitude and the evolution and turbulent mixing characteristics are predicted well. Two different approaches are used to estimate the turbulent dissipation rate, namely using the resolved turbulent energy spectrum and the parameterized subgrid turbulent dissipation rate, and the predicted results provide the upper and lower bounds that encompass the measured values. Model results show significantly higher turbulence in braids of shear instabilities, which is similar to field observations while both the subgrid turbulent dissipation rate and resolved vorticity field can be used as surrogates for measured high acoustic backscatter signals. Simulation results also reveal that the surface velocity divergence/convergence is an effective identifier for the front of the density current and the shear instabilities. To guide future numerical studies in more realistic domains, an evaluation on the effects of different grid resolutions and subgrid viscosity on the resolved flow field and subgrid dissipation rate are discussed.

The use of negative pressure wound therapy to prevent post-operative surgical site infections following pancreaticoduodenectomy

Objective: Rates of superficial surgical site infection (SSI) following pancreaticoduodenectomy remain high despite significant investment in process measures aimed at reducing perioperative infectious complications. Following resection for cancer, complications such as SSI impact adjuvant therapy delivery and portend worse survival. The utilization of an incisional negative pressure dressing (iVAC) has been demonstrated to reduce SSI in other high-risk cohorts. Methods: Following a comprehensive effort to identify patients at high risk for SSI, practice patterns at a single academic center shifted and iVAC use increased. Data regarding SSI were collected in a prospectively maintained database. Individualized patient risk and SSI rate in the cohort receiving iVAC was compared to the cohort receiving standard closure. Results: In total, 436 patients underwent pancreaticoduodenectomy over 21-months. An iVAC was used in 120 patients (27.5%). The overall rate of SSI was 20%. On multivariate analysis, increased risk for SSI was associated with neoadjuvant therapy, preoperative biliary interventions and prior abdominal surgery. Obese patients and patients receiving preoperative biliary intervention were more likely to have an iVAC. Despite this, iVAC use was associated with a decreased rate of SSI (OR 0.45, p < 0.009). In the highest-risk patients, SSI rate was decreased from 49% in patients without an iVAC to 19% with iVAC use (p=0.018). Conclusion: The use of an iVAC following pancreaticoduodenectomy is associated with decreased SSI rates. This is particularly true for patients at highest risk. When integrated with prior work, these data suggest iVAC use may improve adjuvant therapy administration for cancer patients with potential long-term oncologic benefit.Table 1Observed and expected rates of SSI stratified by risk category in patients with and without iVAC placementRisk CategoryˆSSI within 30 days of surgeryp-Value*ExpectedObserved – all patientsObserved – VAC placedObserved – no VAC placed00%29 (13.6%)2 (4.0%)27 (16.5%)0.024132%29 (19.3%)8 (16.3%)21 (20.8%)0.516264%29 (40.3%)4 (19.1%)25 (49.0%)0.018*Comparison between patients who did or did not receive wound VACs.ˆRisk category as defined in prior work [15]. Open table in a new tab *Comparison between patients who did or did not receive wound VACs. ˆRisk category as defined in prior work [15].

Large eddy simulation of dam‐break‐driven swash on a rough‐planar beach

Turbulence characteristics in the swash zone are investigated using a 3-D large eddy simulation model. The numerical model is implemented based on OpenFOAM which solves the filtered Navier-Stokes equations for two immiscible fluids with a standard Smagorinsky subgrid-scale closure. The numerical model is validated with laboratory data for swash flow driven by a dam-break apparatus. The model results demonstrate that the main characteristics of turbulence in the swash zone are different from those in the surf zone, which are mainly induced by surface wave breaking. During uprush phase, bore-generated turbulence has 2-D turbulence characteristics because of limited water depth. Near-bed-generated turbulence is mainly observed during backwash. Turbulence production and turbulent dissipation rate estimated from the model results indicate an imbalance, possibly due to advection at swash front and large roughness used. Touching down of turbulent coherent structure (TCS) is observed during uprush, which drives intense bed shear stress. During the backwash, interaction between TCS and bed is less clear. However, finger-like patterns in the spatial extent of bed shear stress and vertical components of vorticity are predicted during the backwash. The location of the strongest finger patterns in the vertical direction is collocated with that of maximum turbulence production. These finger patterns are likely caused by boundary layer instabilities injected vertically from the bed.

Do standard carotid artery endarterectomy and primary closure technique cause early restenosis in diabetic patients?

IntroductionWe aimed to investigate carotid restenosis in 2-year follow-up in diabetic and nondiabetic patients who underwent standard carotid endarterectomy with primary carotid closure and determine whether diabetes mellitus is a risk factor for early stenosis for this surgical procedure.Material and methodsWe retrospectively assessed the data of patients who underwent standard carotid endarterectomy with primary carotid closure from the hospital registry and outpatient clinic follow-up between January 2006 and January 2012. The study included 25 diabetics and 25 nondiabetics, in total 50 patients. The control carotid Doppler ultrasonographies and/or computed tomography angiographies of the patients at postoperative 1, 6, 12, and 24 months were examined and a stenosis rate between 70% and 99% was regarded as significant carotid restenosis.ResultsWhen the diabetic and nondiabetic group patients were compared for early carotid restenosis at 2 years, there were 3 (12%) patients in the diabetic group and 4 (16%) patients in the nondiabetic group with restenosis. A statistically significant difference in early carotid restenosis was not observed between the two groups (p > 0.05).ConclusionsStandard carotid endarterectomy and primary closure of the artery is a successfully performed surgical procedure in diabetic patients. We concluded that diabetes mellitus is not a risk factor for early restenosis in the diabetic patient population according to the results of our research.

Primary Placement of Incisional Negative Pressure Wound Therapy at Time of Laparotomy for Gynecologic Malignancies.

Wound complications are an important cause of postoperative morbidity amongst patient with gynecologic malignancies. We evaluated whether the placement of prophylactic negative pressure wound therapy (NPWT) at the time of laparotomy for gynecologic cancer surgery reduces wound complication rates. A retrospective analysis of patients undergoing laparotomy with primary wound closure performed by a gynecologic oncologist at a single academic institution over a 5-year study period was performed. Patients who had placement of prophylactic NPWT dressing were compared with patients with a standard closure. Postoperative outcomes were examined. A total of 230 patients were identified: 208 women received standard wound care, 22 received NPWT. Groups were similar in age, prevalence of diabetes, tobacco use, and number of previous abdominal procedures. Intraoperative factors including length of procedure and transfusion requirements were similar. Body mass index for patients receiving standard treatment was 30.67 compared with 41.29 for NPWT group (P < 0.001). Incidence of all wound complications was 19.7% for those receiving standard treatment versus 27.3% for NPWT group (P = 0.40). Length of hospital stay was similar between the 2 groups (5.25 vs 6.22 days, P = 0.20). There were 3 hospital readmissions for wound complications-none occurred in women with a prophylactic NPWT dressing. Despite significantly higher obesity rates, patients with prophylactic NPWT dressing placement had similar rates of wound complications. Our findings suggest a potential therapeutic benefit in the use of prophylactic NPWT for the reduction of wound complications in this high-risk gynecologic oncology patient population.

Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM).

Background and aims: After Peroral Endoscopic Myotomy (POEM), the mucosal incision is closed with endoscopically applied clips. After each clip placement, a subsequent clipping device has to be introduced through the working channel. With the Clipmaster3, three consecutive clips can be placed without reloading which could reduce closure time. We performed a prospective study evaluating efficacy, safety, and ease of use. Closure using Clipmaster3 was compared to closure with standard clips. Methods: Patients undergoing closure with the Clipmaster3 were compared to patients who underwent POEM with standard clip closure. Results: In total, 12 consecutive POEM closures with Clipmaster3 were compared to 24 standard POEM procedures. The Clipmaster3 and the standard group did not differ in sex distribution, age (42 years [29 – 49] vs 41 years [34 – 54] P = 0.379), achalasia subtype, disease duration, length of the mucosal incision (25.0 mm [20 – 30] vs 20.0 mm [20 – 30], P = 1.0), and closure time (622 seconds [438 – 909] vs 599 seconds [488 – 664] P = 0.72). Endoscopically successful closure could be performed in all patients. The proportion of all clips used that were either displaced or discarded was larger for Clipmaster3 (8.8 %) compared to standard closure (2.0 %, P = 0.00782). Ease of handling VAS (visual analogue scale) score for Clipmaster3 did not differ between endoscopist and endoscopy nurse (7 out of 10). Conclusions: Clipmaster3 is feasible and safe for closure of mucosal incisions after POEM. Clipmaster3 was not associated with reduced closure time. Compared to standard closure, more Clipmaster3 clips were displaced or discarded to achieve successful closure. A training effect cannot be excluded as a cause of these results.Study registration: NCT01405417

Hughes Abdominal Repair Trial (HART) - Abdominal wall closure techniques to reduce the incidence of incisional hernias: study protocol for a randomised controlled trial.

BackgroundIncisional hernias are common complications of midline closure following abdominal surgery and cause significant morbidity, impaired quality of life and increased health care costs.The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. This theoretically distributes the load along the incision length as well as across it. There is evidence to suggest that this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared the Hughes Repair with standard mass closure for the prevention of incisional hernia formation following a midline incision.Methods/designThis is a 1:1 randomised controlled trial comparing two suture techniques for the closure of the midline abdominal wound following surgery for colorectal cancer. Full ethical approval has been gained (Wales REC 3, MREC 12/WA/0374). Eight hundred patients will be randomised from approximately 20 general surgical units within the United Kingdom. Patients undergoing open or laparoscopic (more than a 5-cm midline incision) surgery for colorectal cancer, elective or emergency, are eligible. Patients under the age of 18 years, those having mesh inserted or undergoing musculofascial flap closure of the perineal defect in abdominoperineal wound closure, and those unable to give informed consent will be excluded. Patients will be randomised intraoperatively to either the Hughes Repair or standard mass closure. The primary outcome measure is the incidence of incisional hernias at 1 year as assessed by standardised clinical examination. The secondary outcomes include quality of life patient-reported outcome measures, cost-utility analysis, incidence of complete abdominal wound dehiscence and C-POSSUM scores. The incidence of incisional hernia at 1 year, assessed by computerised tomography, will form a tertiary outcome.DiscussionA feasibility phase has been completed. The results of the study will be used to inform current and future practice and potentially reduce the risk of incisional hernia formation following midline incisions.Trial registrationTrial Registration Number: ISRCTN 25616490. Registered on 1 January 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1573-0) contains supplementary material, which is available to authorized users.

Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials.