The open abdomen in trauma, acute care, and vascular and endovascular surgery: comprehensive, expert, narrative review.

BACKGROUND: The open abdomen is an innovation that greatly improved surgical understanding of damage control, temporary abdominal closure, staged abdominal reconstruction, viscera and enteric fistula care, and abdominal wall reconstruction. This article provides an evidence-informed, expert, comprehensive narrative review of the open abdomen in trauma, acute care, and vascular and endovascular surgery. METHODS: A group of 12 international trauma, acute care, and vascular and endovascular surgery experts were invited to review current literature and important concepts surrounding the open abdomen. RESULTS: The open abdomen may be classified using validated systems developed by a working group in 2009 and modified by the World Society of the Abdominal Compartment Syndrome-The Abdominal Compartment Society in 2013. It may be indicated in major trauma, intra-abdominal sepsis, vascular surgical emergencies, and severe acute pancreatitis; to facilitate second look laparotomy or avoid or treat abdominal compartment syndrome; and when the abdominal wall cannot be safely closed. Temporary abdominal closure and staged abdominal reconstruction methods include a mesh/sheet, transabdominal wall dynamic fascial traction, negative pressure wound therapy, and hybrid negative pressure wound therapy and dynamic fascial traction. This last method likely has the highest primary fascial closure rates. Direct peritoneal resuscitation is currently an experimental strategy developed to improve primary fascial closure rates and reduce complications in those with an open abdomen. Primary fascial closure rates may be improved by early return to the operating room; limiting use of crystalloid fluids during the surgical interval; and preventing and/or treating intra-abdominal hypertension, enteric fistulae, and intra-abdominal collections after surgery. The majority of failures of primary fascial closure and enteroatmospheric fistula formation may be prevented using effective temporary abdominal closure techniques, providing appropriate resuscitation fluids and nutritional support, and closing the abdomen as early as possible. CONCLUSION: Subsequent stages of the innovation of the open abdomen will likely involve the design and conduct of prospective studies to evaluate appropriate indications for its use and effectiveness and safety of the above components of open abdomen management.

Abdominal Closure With Reinforcing Suture Decreases Incisional Hernia Incidence After CRS/HIPEC.

Background: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) entails several risk factors for incisional hernia (IH). A few reports available showing incidences between 7% and 17%. At our institution fascia closure has been performed in a 4:1 suture to wound length manner, with a continuous 2-0 polydiaxanone suture (PDS-group) or with a 2-0 polypropylene suture preceded by a reinforced tension line (RTL) suture (RTL-group). Our hypothesis was that these patients might benefit from reinforcing the suture line with a lower IH incidence in this group. The aim was to evaluate the 1-year IH-incidence of the two different closures. Methods: Patients eligible for inclusion were treated with CRS/HIPEC between 2004 and 2019. IH was diagnosed by scrutinizing CT-scans 1 year ±3 months after surgery. Additional data was retrieved from clinical records and a prospective CRS/HIPEC-database. Results: Of 193 patients, 129 were included, 82 in the PDS- and 47 in the RTL-group. RTL-patients were 5 years younger, had less blood loss and more frequent postoperative neutropenia. No difference regarding sex, BMI, recent midline incisions, excision of midline scars, peritoneal cancer index score, complications (≥Clavien-Dindo 3b), or chemotherapy. Ten IH (7.8%) were found, 9 (11%) in the PDS- and 1 (2.1%) in the RTL-group (p = 0.071). Conclusion: An IH incidence of 7.8% in patients undergoing CRS/HIPEC is not higher than after laparotomies in general. The IH incidence in the PDS-group was 11% compared to 2% in the RTL-group. Even though significance was not reached, the difference is clinically relevant, suggesting an advantage with RTL suture.

Pain with sexual activity at 1 and 3 years: Comparing total extraperitoneal with Lichtenstein inguinal hernia repair in a randomized setting (TEPLICH trial).

BACKGROUND: Pain at sexual activity induced by an inguinal hernia or as a cause of its repair is not thoroughly studied. Reported frequencies are between 25% and 30% preoperatively and 10% and 15% postoperatively. The primary aim was to analyze pain at sexual activity at 1 year comparing total extraperitoneal with Lichtenstein repair in a randomized setting. METHODS: Men, 30 to 60 years old, with a primary inguinal hernia were randomized to total extraperitoneal without mesh fixation or Lichtenstein repair. A questionnaire on pain prevalence, frequency, intensity, and impairment of sexual functions caused by pain at sexual activity was introduced. Clinical examination, a questionnaire on sexual function, and the 36-Item Short Form Survey were performed preoperatively and at 1 and 3 years postoperatively. A risk factor analysis for pain at sexual activity as performed. RESULTS: A total of 243 patients (111 total extraperitoneal and 132 Lichtenstein) were included between 2008 and 2014; 97% remained for 1-year and 90% for 3-year analysis. Preoperative pain at sexual activity was reported in 35%, with a reduction to 5.9% in total extraperitoneal and 12.5% in Lichtenstein (P = .098) at 1 year and 7.0% in total extraperitoneal and 9.3% in Lichtenstein (P = .566) at 3 years. Quality of life preoperatively was markedly reduced in patients with pain at sexual activity but restored almost to norm levels at 1 and 3 years. New pain at sexual activity (harm) was seen in 8 patients (3.6%) at 1 year. Risk factors for having postoperative pain at sexual activity were preoperative pain and Lichtenstein technique. CONCLUSION: Pain at sexual activity in inguinal hernia patients is more common than suspected and reduces quality of life. Repair will markedly reduce pain at sexual activity and restore quality of life in most patients without difference between techniques. Patients should be informed on a potential relation between having an inguinal hernia and sexual impairment.

Management of diastasis of the rectus abdominis muscles: recommendations for swedish national guidelines.

BACKGROUND: Diastasis of the rectus abdominis muscle is a common condition. There are no generally accepted criteria for diagnosis or treatment of diastasis of the rectus abdominis muscle, which causes uncertainty for the patient and healthcare providers alike. METHODS: The consensus document was created by a group of Swedish surgeons and based on a structured literature review and practical experience. RESULTS: The proposed criteria for diagnosis and treatment of diastasis of the rectus abdominis muscle are as follows: (1) Diastasis diagnosed at clinical examination using a caliper or ruler for measurement. Diagnostic imaging by ultrasound or other imaging modality, should be performed when concurrent umbilical or epigastric hernia or other cause of the patient's symptoms cannot be excluded. (2) Physiotherapy is the firsthand treatment for diastasis of the rectus abdominis muscle. Surgery should only be considered in diastasis of the rectus abdominis muscle patients with functional impairment, and not until the patient has undergone a standardized 6-month abdominal core training program. (3) The largest width of the diastasis should be at least 5 cm before surgical treatment is considered. In case of pronounced abdominal bulging or concomitant ventral hernia, surgery may be considered in patients with a smaller diastasis. (4) When surgery is undertaken, at least 2 years should have elapsed since last childbirth and future pregnancy should not be planned. (5) Plication of the linea alba is the firsthand surgical technique. Other techniques may be used but have not been found superior. DISCUSSION: The level of evidence behind these statements varies, but they are intended to lay down a standard strategy for treatment of diastasis of the rectus abdominis muscle and to enable uniformity of management.

Dynamic Fascial Closure With Vacuum-Assisted Wound Closure and Mesh-Mediated Fascial Traction (VAWCM) Treatment of the Open Abdomen-An Updated Systematic Review.

Introduction: Several different temporary abdominal closure techniques are described in the context of open abdomen treatment. Techniques based on dynamic fascial closure combined with negative pressure therapy have gained popularity and seem to result in the highest fascial closure rates without increased complications and are highlighted in recent guidelines and recommendations. One dynamic closure technique is the vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) technique, first described in 2007. The aim of this systematic review was to evaluate the VAWCM technique regarding a number of short- and long-term results. Materials and Methods: A systematic literature search was performed in PubMed, EMBASE, and Cochrane Library databases for articles published between January 1, 2006 and May 8, 2020. The review was independently performed by the two authors according to the PRISMA statements for reporting systematic reviews and meta-analyses. Results were pooled for presentation of weighted means when applicable. Results: A total of 220 articles were screened by title and abstract. Thirty-two articles were assessed for eligibility by full-text review and 15 articles finally remained for review. A total of 600 patients treated with VAWCM were included. The pooled weighted means were as follows: fascial closure, 83.5%; enteroatmospheric fistula, 5.6%; planned ventral hernia, 6.2%; in-hospital survival, 72%; and incisional hernia incidence, 40.5%. Long-term survival ranged between 22 and 72%. Quality of life (SF-36) was reported in two studies showing lower scores than the population mean especially in physical domains. Incisional hernia resulted in lower scores in one but not in the other study. Discussion: The results of 600 VAWCM-treated patients from 15 studies were evaluated in this systematic review. Earlier findings with high fascial closure rates, low enteroatmospheric fistula, and planned ventral hernia rates as well as high incisional hernia incidences were underlined. Permanent mesh for efficient fascial traction and reinforcement at fascial closure seem to be the next step in evolving an optimal temporary closure technique in open abdomen treatment.

The Relevance of Sexual Dysfunction Related to Groin Pain After Inguinal Hernia Repair - The SexIHQ Short Form Questionnaire Assessment.

BACKGROUND: Chronic postoperative pain after inguinal hernia surgery can affect sexual function. A new short form questionnaire for inguinal hernia pain related sexual dysfunction (SexIHQ) was introduced and applied to a register based cohort of total extra-peritoneal hernioplasty (TEP) operated patients. METHODS: Sexually active men, 30-60 years old, recorded in the Swedish Hernia Register for a primary inguinal hernia TEP operation were included. Two initial questions of the SexIHQ identify patients with pain at sexual activity. Only these patients proceeded to answer the specific questions on pain-induced impairment of sexual activity, pain frequency and intensity, physical functions (erection and ejaculation), and symptoms of depression. SexIHQ, the Short Form-36 (SF-36), the Inguinal Pain Questionnaire (IPQ) were mailed to participants for long term follow up. RESULTS: In 538 included patients, 44 (8.2%) reported pain during sexual activity at mean 33 months after surgery. Sexual dysfunction was seen in 33 of these patients. A postoperative complication was a risk factor for pain during sexual activity; OR 4.89 (95% CI 1.92-12.43; p < 0.001). Quality-of-life was reduced in almost all SF-36 domains in patients with pain during sexual activity. CONCLUSIONS: A short form questionnaire, suitable for large cohorts, was developed to assess sexual dysfunction due to groin pain after inguinal hernia repair in male patients. Sexual dysfunction due to groin pain after hernia surgery by TEP is surprisingly common. Patients should preoperatively be informed of the risk of having pain during sexual activity following groin hernia surgery.

Vacuum-assisted wound closure and mesh-mediated fascial traction for open abdomen therapy - a systematic review.

BACKGROUND: The aim of this paper was to review the literature on vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) in open abdomen therapy. It was designed as systematic review of observational studies. METHODS: A Pub Med, EMBASE and Cochrane search from 2007/01-2016/07 was performed combining the Medical Subject Headings "vacuum", "mesh-mediated fascial traction", "temporary abdominal closure", "delayed abdominal closure", "open abdomen", "abdominal compartment syndrome", "negative pressure wound therapy" or "vacuum assisted wound closure". RESULTS: Eleven original studies were found including patients numbering from 7 to 111. Six studies were prospective and five were retrospective. Nine studies were on mixed surgical (n = 9), vascular (n = 6) and trauma (n = 6) patients, while two were exclusively on vascular patients. The primary fascial closure rate per protocol varied from 80-100%. The time to closure of the open abdomen varied between 9-32 days. The entero-atmospheric fistula rate varied from 0-10.0%. The in-hospital survival rate varied from 57-100%. In the largest prospective study, the incisional hernia rate among survivors at 63 months of median follow-up was 54% (27/50), and 16 (33%) repairs out of 48 incisional hernias were performed throughout the study period. The study patients reported lower short form health survey (SF-36) scores than the mean reference population, mainly dependent on the prevalence of major co-morbidities. There was no difference in SF-36 scores or a modified ventral hernia pain questionnaire (VHPQ) at 5 years of follow up between those with versus those without incisional hernias. CONCLUSIONS: A high primary fascial closure rate can be achieved with the vacuum-assisted wound closure and meshmediated fascial traction technique in elderly, mainly non-trauma patients, in need of prolonged open abdomen therapy.

Quality of Life and Surgical Outcome 1 Year After Open and Laparoscopic Incisional Hernia Repair: PROLOVE: A Randomized Controlled Trial.

OBJECTIVE: Patients suffering from an incisional hernia after abdominal surgery have an impaired quality of life (QoL). Surgery aims to improve QoL with a minimum risk of further complications. The aim was to analyze QoL, predictors for outcome, including recurrence and reoperation rates during the first postoperative year. METHODS: In a randomized controlled trial comparing laparoscopic and open mesh repair, 133 patients were assessed preoperatively and after 1 year with regard to QoL using the Short Form-36 (SF-36), visual analog scale (pain, movement limitation, and fatigue), and questions addressing abdominal wall complaints. Factors concerning recurrence, reoperations, satisfaction, and improved QoL were analyzed. RESULTS: A total of 124 patients remained for analysis. All SF-36 scores except mental composite score increased, reaching and maintaining levels of the Swedish norm already after 8 weeks with no difference between groups. Event-free recovery was seen in 85% in the laparoscopic group and in 65% of the open cases (P < 0.010). Five recurrences occurred after laparoscopic surgery and 1 in the open group (P < 0.112). Overall, abdominal wall complaints decreased from 82% to 13% of the patients; and 92% were satisfied with the result after 1 year.In univariable logistic regression analyses laparoscopic surgery and male sex predicted an event-free recovery. Obesity (BMI > 30) predicted better outcome with regard to QoL. No predictors for recurrence or satisfaction were identified. CONCLUSIONS: Patients with incisional hernia benefit substantially from surgery concerning QoL, independent of surgical technique. An event-free recovery occurred frequently after laparoscopic surgery. SF-36 seems well suited for assessing surgical outcome in patients after incisional hernia repair.

Impact of Mesh Fixation on Chronic Pain in Total Extraperitoneal Inguinal Hernia Repair (TEP): A Nationwide Register-based Study.

BACKGROUND: Mesh fixation is used to prevent recurrence at the potential risk for chronic pain in TEP. The aim was to compare the impact of permanent fixation (PF) with no fixation (NF)/nonpermanent fixation (NPF) of mesh on chronic pain after TEP repair for primary inguinal hernia. METHODS: Men, 30 to 75 years old, consecutively registered in the Swedish Hernia Register for a TEP primary repair in 2005 to 2009, were included in a mail survey using SF-36 and the Inguinal Pain Questionnaire (IPQ). Primary endpoint was IPQ question "Did you have pain during past week that could not be ignored." Risk factors for chronic pain and recurrent operations were analyzed. RESULTS: A total of 1110 patients were included (325 PF, 785 NF/NPF) with 7.7% reporting pain at median 33 months follow-up. No difference regarding primary endpoint pain (P < 0.462), IPQ and SF-36 subscales were seen. Recurrent operation was carried out in 1.4% during 7.5 years follow-up with no difference between PF- and NF-groups including subgroups of medial hernias. All SF-36 subscale-scores were equal to or better than the Swedish norm. A postoperative complication was a risk factor for chronic pain (OR 2.44, 95% CI 1.23-5.25, P < 0.023). CONCLUSIONS: The TEP procedure for primary inguinal hernia repair in men is associated with a low frequency of chronic pain and recurrent operations, with no difference between permanent fixation and no/nonpermanent fixation of mesh in a nationwide population-based study. TEP without fixation reduces costs and is safe for all patients.

Laparoscopic transcystic laser lithotripsy for common bile duct stone clearance.

PURPOSE: Laparoscopic transcystic common bile duct (CBD) exploration is a safe single-stage procedure for CBD stone clearance. The aim of this report was to describe our experience of transcystic laser lithotripsy in patients with complex CBD stones. MATERIALS AND METHODS: Data from consecutive patients treated with transcystic holmium:YAG laser lithotripsy was collected and analyzed concerning age, sex, number of stones, duct clearance, conversions, operation time, complications, and hospital stay. RESULTS: Duct clearance was achieved in all (n=8) patients as a single-stage procedure, although 1 had to be converted to open surgery. Median operation time was 225 minutes and hospital stay was 2 days. There was no postoperative morbidity or mortality. CONCLUSIONS: Laparoscopic transcystic use of holmium:YAG laser for complex CBD stones seems safe and efficient even though operation time is long. The technique has the potential of completing the treatment armamentarium for transcystic laparoscopic clearance of difficult CBD stones.

Evaluation of the open abdomen classification system: a validity and reliability analysis.

BACKGROUND: Classification of the open abdomen (OA) status is essential for clinical studies on the subject and may help to improve OA therapy. This is a validity and reliability analysis of the OA classification proposed by the World Society of the Abdominal Compartment Syndrome in 2013. METHODS: Prospective data on 111 consecutive OA patients treated with vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) was used. For validity analysis, OA grades were compared with fascial closure and mortality. For reliability analysis, operative reports were graded by three external raters on two different occasions and the results compared. Instructions for use of the classification were constructed and studied by the external raters beforehand. RESULTS: The in-hospital mortality rate was 30 % (33/111). The delayed primary fascial closure rate was 89 % (85/95). Most complex grade (p = 0.033), deteriorating grade (p = 0.045), enteric leak (p = 0.001), and enteroatmospheric fistula (p = 0001) were associated with worse clinical outcomes, while initial grade, grade 1A only, contamination, fixation, and frozen abdomen were not. A floor effect was observed, with 20 % of patients receiving the lowest grade throughout OA period. Inter-rater reliability, expressed as intra-class correlation coefficient (ICC), was 0.77, 0.76, and 0.88 (95 % confidence interval 0.66-0.84, 0.65-0.84, and 0.81-0.92, respectively) and test-retest reliability 1.0, 0.99, and 0.95, respectively. CONCLUSIONS: More complex OA grades were associated with worse clinical outcomes. However, favorable clinical results with the VAWCM technique caused many patients to receive the lowest grade, thus causing a floor effect and lower validity. Inter-rater and test-retest reliability was 'good' to 'very good'.

Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial.

OBJECTIVE: : The aim of the trial was to compare laparoscopic technique with open technique regarding short-term pain, quality of life (QoL), recovery, and complications. BACKGROUND: : Laparoscopic and open techniques for incisional hernia repair are recognized treatment options with pros and cons. METHODS: : Patients from 7 centers with a midline incisional hernia of a maximum width of 10 cm were randomized to either laparoscopic (LR) or open sublay (OR) mesh repair. Primary end point was pain at 3 weeks, measured as the bodily pain subscale of Short Form-36 (SF-36). Secondary end points were complications registered by type and severity (the Clavien-Dindo classification), movement restrictions, fatigue, time to full recovery, and QoL up to 8 weeks. RESULTS: : Patients were recruited between October 2005 and November 2009. Of 157 randomized patients, 133 received intervention: 64 LR and 69 OR. Measurements of pain did not differ, nor did movement restriction and postoperative fatigue. SF-36 subscales favored the LR group: physical function (P < 0.001), role physical (P < 0.012), mental health (P < 0.022), and physical composite score (P < 0.009). Surgical site infections were 17 in the OR group compared with 1 in the LR group (P < 0.001). The severity of complications did not differ between the groups (P < 0.213). CONCLUSIONS: : Postoperative pain or recovery at 3 weeks after repair of midline incisional hernias does not differ between LR and OR, but the LR results in better physical function and less surgical site infections than the OR does. (ClinicalTrials.gov Identifier: NCT00472537).

Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases.

BACKGROUND: This phase II randomized, placebo-controlled study was conducted to evaluate efficacy and safety of radium-223 in patients with castration-resistant prostate cancer (CRPC) and painful bone metastases. Twelve- and 18-month survival results were reported previously. Here we report 24-month overall survival (OS) and safety data from the period 12 to 24 months after the first injection of study medication. METHODS: Patients with CRPC and bone pain were randomized 1:1 to receive 4 injections of radium-223 (50 kBq/kg [n = 33]) or placebo (n = 31) after external-beam radiotherapy; each injection was given every 4 weeks. Endpoints for this report were 24-month OS, long-term safety, and treatment-related adverse events (AEs) occurring in the 12- to 24-month period. RESULTS: After 24 months, 10 (30%) patients were alive in the radium-223 group compared with 4 patients (13%) in the placebo group. Patients who received at least 1 dose of study medication had a median OS of 65 weeks in the radium-223 group vs. 46 weeks in the placebo group (log-rank P = .056). The hazard ratio (HR) for OS, adjusted for baseline covariates, was 0.476 (95% confidence interval [CI], 0.258-0.877; Cox regression P = .017). The most frequent cause of death for both arms was disease progression. There were no reports of treatment-related AEs or long-term hematologic toxicity during the 12- to 24-month follow-up. CONCLUSION: Radium-223 had a highly favorable safety profile, with no evidence of second malignancies at 24-month follow-up. The significant improvement in OS observed in patients receiving radium-223 vs. placebo suggests that treatment of bone disease with radium-223 has survival benefits.

Intra-abdominal hypertension and abdominal compartment syndrome in nontrauma surgical patients.

Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are commonly encountered in nontrauma surgical patients. Depending on the etiology of the patient's surgical illness (ruptured abdominal aortic aneurysm, acute pancreatitis, burns, etc.), both the incidence and mortality of IAH/ACS may be quite high. Recent advances in both the diagnosis and resuscitation of these surgical patients have resulted in significantly improved survival over that seen in years past. Intra-abdominal pressure measurements should be performed in any surgical patient who demonstrates risk factors for IAH/ACS.

Pressure at the bowel surface during topical negative pressure therapy of the open abdomen: an experimental study in a porcine model.

BACKGROUND: Topical negative pressure (TNP) therapy is increasingly used in open abdomen management. It is not known to what extent this pressure propagates through the dressing to the bowel surface, potentially increasing the risk of bowel fistula formation. The present study in a porcine model was designed to evaluate pressure propagation. METHODS: A commercially available TNP therapy system (ABThera/VAC) was applied in six pigs after laparotomy. Pressure sensors were placed in predetermined positions in the dressing and in the abdominal cavity and the pressure was registered at TNP settings of -50, -75, -100, -125, and -150 mmHg. Next, after infusing 200 ml of saline into the abdomen through a catheter, the amount of fluid drained through the system during 10 min of TNP therapy was registered. Finally, pressure was measured above and below eight layers of paraffin gauzes during TNP therapy. RESULTS: Observed pressure within the outer two foams and the foam of the visceral protective layer correlated with preset TNP. The median pressure at the bowel surface was between -2 and -10 mmHg, regardless of preset TNP. Median fluid drainage was 95% of the infused fluid at -75 mmHg and 124% at -150 mmHg. Paraffin gauzes had a limited isolating effect, reducing the pressure by 13% in median. CONCLUSIONS: Negative pressure reaching the bowel surface during TNP therapy with the ABThera system is limited for all TNP levels. Reduced therapy pressure does not lead to reduced pressure at the bowel surface. The system drains the abdominal cavity completely of fluid. Paraffin gauzes are of limited value as a means of pressure isolation.

Novel technique for treatment of a renal artery occlusion in a child with neurofibromatosis: a combined endovascular and laparoscopic approach.

Neurofibromatosis is associated with mid-aortic dysplasia, renal artery aneurysms and renal artery ostial stenosis, or occlusions in about 1% of cases. We describe a novel approach to recanalize an occluded renal artery in a 10-year-old girl with neurofibromatosis and difficulty in pharmacologically controlling her hypertension. Normally, when reconstruction is required, an open operative technique is used. We report on the combined use of laparoscopic exposure and percutaneous retrograde puncture of the occluded renal artery, which could be recanalized and stented. The pros and cons of this new approach are discussed.

Vacuum-assisted wound closure and mesh-mediated fascial traction--a novel technique for late closure of the open abdomen.

BACKGROUND: Open abdomen (OA) treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum-assisted wound closure (VAWC) technique. However, we have experienced occasional failures with this technique in cases with severe visceral swelling needing longer treatment periods with open abdomen. Feasibility and short-term outcome of a novel combination of techniques for managing the open abdomen are presented. METHODS: The VAWC technique was combined with medial traction of the fasciae through a temporary mesh in seven consecutive patients. The VAWC-system was changed and the mesh tightened every 2-3 days. RESULTS: Median (range) age in the 7 men was 65 (17-78) years. The diagnoses were ruptured abdominal aortic aneurysm (AAA) (3), operation for juxtarenal AAA (1), iatrogenic aortic lesion (1), trauma (1) and abdominal abscesses (1). Four patients were decompressed due to abdominal compartment syndrome (ACS) or intra-abdominal hypertension, and 3 could not be closed after laparotomy. Intra-abdominal pressure prior to OA treatment was 24 (17-36) mmHg. Maximal separation of the fasciae was 16 (7 -30) cm. Delayed primary closure was achieved in all patients after 32 (12-52) days with OA. No recurrent ACS was seen. No technique-specific complication was observed. Two small incisional hernias, one intra-abdominal abscess and one wound infection occurred in three patients. CONCLUSIONS: Delayed primary closure in cases with severe visceral swelling and long periods of OA seems feasible with this technique.

Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study.

BACKGROUND: The alpha-emitter radium-223 ((223)Ra) is a bone-seeking radionuclide studied as a new treatment for patients with bone metastases from hormone-refractory prostate cancer. We aimed to study mature outcomes from a randomised, multicentre, phase II study of (223)Ra. METHODS: Patients with hormone-refractory prostate cancer and bone pain needing external-beam radiotherapy were assigned to four intravenous injections of (223)Ra (50 kBq/kg, 33 patients) or placebo (31 patients), given every 4 weeks. Primary endpoints were change in bone-alkaline phosphatase (ALP) concentration and time to skeletal-related events (SREs). Secondary endpoints included toxic effects, time to prostate-specific-antigen (PSA) progression, and overall survival. All tests were done at a 5% significance level, based on intention to treat. FINDINGS: Median relative change in bone-ALP during treatment was -65.6% (95% CI -69.5 to -57.7) and 9.3% (3.8-60.9) in the (223)Ra group and placebo groups, respectively (p<0.0001, Wilcoxon ranked-sums test). Hazard ratio for time to first SRE, adjusted for baseline covariates, was 1.75 (0.96-3.19, p=0.065, Cox regression). Haematological toxic effects did not differ significantly between two groups. No patient discontinued (223)Ra because of treatment toxicity. Median time to PSA progression was 26 weeks (16-39) versus 8 weeks (4-12; p=0.048) for (223)Ra versus placebo, respectively. Median overall survival was 65.3 weeks (48.7-infinity) for (223)Ra and 46.4 weeks (32.1-77.4) for placebo (p=0.066, log rank). The hazard ratio for overall survival, adjusted for baseline covariates was 2.12 (1.13-3.98, p=0.020, Cox regression). INTERPRETATION: (223)Ra was well tolerated with minimum myelotoxicity, and had a significant effect on bone-ALP concentrations. Larger clinical trials are warranted to study (223)Ra on the prevention of SREs and on overall survival in patients with hormone-refractory prostate cancer. Bone-targeting properties of (223)Ra could also potentially be used for treating skeletal metastasis from other primary cancers.