Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn's disease: the LIR!C Trial.

OBJECTIVE: Evaluate the cost-effectiveness of laparoscopic ileocaecal resection compared with infliximab in patients with ileocaecal Crohn's disease failing conventional therapy. DESIGN: A multicentre randomised controlled trial was performed in 29 centres in The Netherlands and the UK. Adult patients with Crohn's disease of the terminal ileum who failed >3 months of conventional immunomodulators or steroids without signs of critical strictures were randomised to laparoscopic ileocaecal resection or infliximab. Outcome measures included quality-adjusted life-years (QALYs) based on the EuroQol (EQ) 5D-3L Questionnaire and the Inflammatory Bowel Disease Questionnaire (IBDQ). Costs were measured from a societal perspective. Analyses were performed according to the intention-to-treat principle. Missing cost and effect data were imputed using multiple imputation. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty. RESULTS: In total, 143 patients were randomised. Mean Crohn's disease total direct healthcare costs per patient at 1 year were lower in the resection group compared with the infliximab group (mean difference €-8931; 95% CI €-12 087 to €-5097). Total societal costs in the resection group were lower than in the infliximab group, however not statistically significant (mean difference €-5729, 95% CI €-10 606 to €172). The probability of resection being cost-effective compared with infliximab was 0.96 at a willingness to pay (WTP) of €0 per QALY gained and per point improvement in IBDQ Score. This probability increased to 0.98 at a WTP of €20 000/QALY gained and 0.99 at a WTP of €500/point of improvement in IBDQ Score. CONCLUSION: Laparoscopic ileocaecal resection is a cost-effective treatment option compared with infliximab. CLINICAL TRIAL REGISTRATION NUMBER: Dutch Trial Registry NTR1150; EudraCT number 2007-005042-20 (closed on 14 October 2015).

Assessing Quality of Syndesmotic Reduction in Surgically Treated Acute Syndesmotic Injuries: A Systematic Review.

There is no universal method with cutoff values for the assessment of distal tibiofibular joint reduction in acute syndesmotic injuries. It is important to detect malreductions because they may lead to impaired functional outcome and may demand reoperations. The aim of this study was to systematically review the literature to evaluate the appropriateness of different image techniques in determining syndesmotic malalignment. A literature search was conducted in Medline, Embase, and the Cochrane Library to search for articles assessing syndesmotic reduction. Excluded were articles where no criteria and/or measurements for syndesmotic reduction were provided, only normative values were provided and reviews. In total, 2157 articles were found, of which 1421 studies were screened for title and abstract after exclusion of duplicates. One hundred ten studies were eligible for full-text analysis. Of these, 61 were excluded. Three studies where added after screening the included references. Fifty-two studies were included, of which 32 were original publications and 20 were publications referring to the original publications. From the original publications, 14 used plains radiographs, 19 computed tomographic (CT) scans, and 5 used 3-dimensional CT scans (some authors used >1 modality in their study). For each modality, a large number of parameters and different cutoff values were reported. CT scanning is superior to plain radiography in the assessment of the quality of joint reduction. Parameters used the most were fibular position in the incisura and fibular rotation. The criteria for adequate reduction should at least include the position of the fibula in the incisura and rotation of the fibula, while ensuring adequate fibular length, all equaling or at least approaching the values of the uninjured contralateral side.

The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019).

BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment. METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm. DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course. TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.

Tranexamic acid in hip hemiarthroplasty surgery: a systematic review and meta-analysis.

PURPOSE: Anemia is one of the most common complications after hip fracture surgery. Tranexamic acid (TXA) has been considered effective in preventing anemia in total hip arthroplasty, but its role in hemiarthroplasty is debated. The aim of this systematic review was to investigate the efficacy and safety of perioperative TXA for hip hemiarthroplasty. METHODS: A systematic literature search was performed to identify studies comparing adult patients who underwent hemiarthroplasty for a hip fracture with and without perioperative TXA. The primary outcome was transfusion rate. Secondary outcomes included postoperative hemoglobin, length of hospital stay, adverse events (i.e., deep venous thromboses and pulmonary embolism), and 30-day mortality. RESULTS: In total, 13 articles were included, comprising 54,843 patients of whom 14.1% received perioperative TXA. TXA was applied intravenous in ten studies, topical in two studies, one study investigated both. Pooled results showed a significant reduction in transfusion rate (pooled RR: 0.48, 95% CI 0.40-0.58, p < 0.01). Postoperative hemoglobin and length of stay were investigated in nine studies, pooled results showed significant improvement of both outcomes for patients that received TXA. Eleven studies investigated thromboembolic events, and there was no statistical difference in deep venous thromboses (pooled RR: 0.67, 95% CI 0.18-2.56, p = 0.56) or pulmonary embolism (pooled RR: 1.10, 95% CI 0.45-2.68, p = 0.83) among the two groups. There was a significant reduction in 30-day mortality for patients that received TXA. CONCLUSION: TXA can be considered effective and safe for patients undergoing hip hemiarthroplasty, with a reduction in transfusion rate and increase in postoperative hemoglobin, without increasing adverse events. Optimal timing, dosage, and type of administration of TXA remain unclear.

Alternative specimen extraction techniques after laparoscopic emergency colectomy in inflammatory bowel disease.

BACKGROUND: Omitting the extraction site incision potentially further decreases the abdominal wall trauma in laparoscopic surgery. The purpose of this study was to report the results of alternative specimen extraction techniques after laparoscopic emergency colectomy in patients with inflammatory bowel disease (IBD). METHODS: Ten consecutive patients with IBD underwent (sub)acute emergency colectomy for refractory disease from October 2009 until December 2010. The specimen was retrieved via the stoma site in three and transrectally in seven patients. Patient data were prospectively collected. In case of later completion proctectomy and pouch procedure, adhesions were systematically scored. RESULTS: The extraction techniques were all feasible. Median operative time was 219 (interquartile range (IQR), 197-232) min. The pain scores and morphine requirement in patients decreased quickly after surgery. No infectious complications occurred. In five patients, a completion proctectomy was performed at a median time of 7 (IQR, 3.8-9.3) months after colectomy. All patients showed absence of any adhesions in the pelvis. In two patients, limited adhesions of the cut side of the mesentery were present. CONCLUSIONS: Specimen extraction via the rectum or stoma site is a safe, alternative way to extract the specimen after laparoscopic colectomy. No infectious complications were observed postoperatively and no pelvic adhesions were found during completion proctectomy.

The proximal femur nail antirotation: an identifiable improvement in the treatment of unstable pertrochanteric fractures?

BACKGROUND: The optimal surgical treatment of patients with an unstable extracapsular proximal femoral fracture is yet to be found. From the biomechanical point of view, the use of an intramedullary device in combination with a dynamic femoral head/neck stabilization implant seems an optimal technique. One of these intramedullary devices, the Proximal Femoral Nail (PFN), has several drawbacks in practice. The Proximal Femur Nail Antirotation (PFNA) has been designed to address these. We hypothesized that the placement of one femoral head/neck fixation device in the PFNA would improve positioning of the implant in the femoral head compared with the PFN and reduce the number of reoperations in both short and long term. METHODS: We followed 157 consecutive patients with unstable trochanteric fractures (Arbeitsgemeinschaft für Osteosynthesefragen classification 31.A.2 and A.3) treated with a PFN or a PFNA for 1 year. The radiologic position of the implant was evaluated, and the postoperative local and systemic complications were registered. RESULTS: The position of the femoral head/neck stabilization implant was "good" in 39 (44.8%) patients in the PFN group and 23 (32.9%) patients in the PFNA group; the position was "acceptable" in 30 (34.5%) versus 33 (47.1%) patients, and in 18 (20.7%) versus 14 (20%) patients, the position was "poor" (p = 0.277). Because of implant-related complications, three patients in the PFN group and four patients in the PFNA group needed an early reoperation (p = 0.136). A late reoperation because of implant-related complications was performed in 13 patients in the PFN group and in three in the PFNA group (p = 0.016). CONCLUSIONS: This study shows that osteosynthesis with the PFNA does not improve the position of the implant in the femoral head compared with the PFN. However, the risk of a secondary complication and the necessity of a late reoperation are significantly higher in patients treated with a PFN compared with patients treated with a PFNA.

Bipolar clavicular fractures and treatment options.

INTRODUCTION: Fractures of the clavicle are common injuries, accounting 2.6-4% of all fractures in adults. Of these fractures, 21-28% are lateral clavicle fractures and 2-3% are medial clavicle fractures. Bipolar clavicle fractures are defined as a lateral and medial fracture and are uncommon. There is no consensus on the treatment of these fractures. The aim of this study is to provide a treatment on bipolar clavicle fractures based on the current literature. METHODS: The electronic databases PubMed, the Cochrane library and EMBASE were searched up on September 25th, 2017. Two reviewers (KR and TG) independently screened titles and abstracts for their relevance. Studies designed to evaluate the outcomes of conservative and/or operative treatment of segmental bipolar clavicle fractures in adults (> 16 years) were included. Editorials and commentaries were excluded, as well as synthetic, cadaveric and animal studies. Primary outcomes considered were pain reduction and shoulder function. Secondary outcomes considered are complications. RESULTS: Ten studies reporting results from ten patients were included for the review. In most patients, if treated operatively, surgical treatment with the use of double plating was performed. Only in elderly patients conservative treatment was adopted. All included patients were pain free and had a full range of motion after 3-6 months. Only two case reports provided a DASH score, while in eight studies no functional outcome score was measured. CONCLUSION: A missed bipolar fracture can complicate the clinical progress. Surgical management of these fractures may be necessary; however, the treatment of choice depends on the age of the patient, daily activities and comorbidity.

Supporting the medial hinge in proximal humerus fractures with an intramedullary plate.

Proximal humerus fractures are common and approximately 20% of displaced fractures may benefit from surgery. A lack of medial support is found to be a predictor of failure after surgical fixation of proximal humerus fractures. The optimal technique for restoring the medial hinge is unclear. We describe two cases of patients with a dislocated 4-part humerus fracture treated with a locking plate and an additional small intramedullary plate to support the medial hinge. This technique is simple and allows for an enhanced stability of the medial hinge during and after surgery.

Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: retrospective long-term follow-up of the LIR!C trial.

BACKGROUND: The LIR!C trial showed that laparoscopic ileocaecal resection is a cost-effective treatment that has similar quality-of-life outcomes to treatment with infliximab, an anti-tumour necrosis factor (TNF) drug. We aimed to compare long-term outcomes of both interventions and identify baseline factors associated with the duration of treatment effect in each group. METHODS: In this retrospective follow-up study, we collected data from patients who participated in the LIR!C trial, a multicentre randomised controlled trial that compared quality of life after surgical resection versus infliximab in adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease. From Jan 1 to May 1, 2018, we collected follow-up data from the time from enrolment in the LIR!C trial until the last visit at either the gastrointestinal surgeon or gastroenterologist. In this study, outcomes of interest were need for surgery or repeat surgery or anti-TNF therapy, duration of treatment effect, and identification of factors associated with the duration of treatment effect. Duration of treatment effect was defined as the time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery). FINDINGS: We collected long-term follow-up data for 134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group. Median follow-up was 63·5 months (IQR 39·0-94·5). In the resection group, 18 (26%) of 69 patients started anti-TNF therapy and none required a second resection. 29 (42%) patients in the resection group did not require additional Crohn's disease-related medication, although 14 (48%) of these patients were given prophylactic immunomodulator therapy. In the infliximab group, 31 (48%) of 65 patients had a Crohn's disease-related resection, and the remaining 34 patients maintained, switched, or escalated their anti-TNF therapy. Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52). In both groups, therapy with an immunomodulator, in addition to the allocated treatment, was associated with duration of treatment effect (hazard ratio for resection group 0·34 [95% CI 0·16-0·69] and for infliximab group 0·49 [0·26-0·93]). INTERPRETATION: These findings further support laparoscopic ileocaecal resection as a treatment option in patients with Crohn's disease with limited (affected segment ≤40 cm) and predominantly inflammatory terminal ileitis for whom conventional treatment is not successful. FUNDING: None.

Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.

BACKGROUND: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. METHODS: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). FINDINGS: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF. INTERPRETATION: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy. FUNDING: Netherlands Organisation for Health Research and Development.

Health-related quality of life and disability in patients with ulcerative colitis and proctocolectomy with ileoanal pouch versus treatment with anti-TNF agents.

BACKGROUND AND AIMS: We compared health-related quality of life (HRQL) and disability in ulcerative colitis (UC) patients in remission with anti-tumor necrosis factor agents (TNF) or after restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA). METHODS: Two patient cohorts were studied. The first group consisted of patients in remission after RPC with IPAA (surgery group). The second group consisted of patients in remission with infliximab or adalimumab (medical group). For inclusion in the surgery group the pouch had to be functional for ≥1year and patients were excluded in case of postoperative complications. In the medical group, patients had to be on maintenance therapy with anti-TNF agents for ≥1year and in clinical remission. HRQL and disability outcomes were assessed using SF-36, COREFO, WPAI:UC and EORTC questionnaires. RESULTS: 60 patients were included, 30 patients in both groups. 58 out of 60 patients (97%) returned the completed questionnaires: 29 patients in the surgery group (median age 42 years [22-67]; 48% female) and 29 patients in the medical group (median age 45 years [19-68]; 65% female). Patient characteristics were comparable between the two groups. There were no significant differences in SF-36, WPAI:UC and EORTC questionnaires between both groups, except for the medication and stool frequency scale (COREFO questionnaire) that was significantly higher in the surgery vs. the medical group (p=0.004 and p<0.001, respectively). CONCLUSION: HRQL and disability were not different among the medical and surgical group, except for stool frequency and anti-diarrhea medication use that was significantly higher in surgically treated patients.

Single-port versus multiport laparoscopic ileocecal resection for Crohn's disease.

BACKGROUND AND AIMS: Several case series have demonstrated the feasibility of single-port laparoscopic ileocecal resection in Crohn's disease. However, only a few studies compared the single-port with a multiport laparoscopic ileocecal approach. The aim of this study was to compare short term surgical outcome parameters between single-port and multiport laparoscopic ileocecal resections for Crohn's disease. METHODS: Twenty-one patients who underwent single-port laparoscopic ileocecal resection between March 2010 and September 2012 were prospectively registered. A matched comparison on a 1:2 basis was performed with patients who underwent multiport laparoscopic ileocecal resection from January 1999 to March 2010. Matching parameters were BMI, length of diseased bowel resected and the presence of fistulas. Endpoints were the length of postoperative hospital stay, operative time, conversions, complications, postoperative pain scores and postoperative analgesia consumption. RESULTS: Twenty-one patients undergoing single-port resection were matched to 42 patients undergoing multiport resection. The postoperative stay (4 days, iqr 4-5 vs. 5 days, iqr 4-6; p=0.033), operative time (103 min, iqr 94.0-121.0 vs. 123.5 min, iqr 100.0-157.0; p=0.036) and morphine use on the first postoperative day (12.5 mg, iqr 5.0-33.3 vs. 28 mg, 15.0-50.0; p=0.012) differed significantly. Postoperative pain scores and complications were similar in both groups. This study was limited by potential selection bias. CONCLUSIONS: Single-port laparoscopic ileocecal resection is safe and feasible in Crohn's disease and is associated with less need for pain medication postoperatively as opposed to multiport laparoscopic ileocecal resection.