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Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage. MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0–3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046. Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0–3 at 365 days (adjusted risk difference 4% [95% CI −4 to 12]; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012). For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons. National Institute of Neurological Disorders and Stroke and Genentech.

Background The minimally invasive esophagectomy (MIE) is widely being implemented for esophageal cancer in order to reduce morbidity and improve quality of life. Non-randomized studies investigating the mid-term quality of life after MIE show conflicting results at 1-year follow-up. Therefore, the aim of this study is to determine whether MIE has a continuing better mid-term 1-year quality of life than open esophagectomy (OE) indicating both a faster recovery and less procedure-related symptoms. Methods A one-year follow-up analysis of the quality of life was conducted for patients participating in the randomized trial in which MIE was compared with OE. Late complications as symptomatic stenosis of anastomosis are also reported. Results Quality of life at 1 year was better in the MIE group than in the OE group for the physical component summary SF36 [50 (6; 48–53) versus 45 (9; 42–48) p .003]; global health C30 [79 (10; 76–83) versus 67 (21; 60–75) p .004]; and pain OES18 module [6 (9; 2–8) versus 16 (16; 10–22) p .001], respectively. Twenty six patients (44 %) in the MIE and 22 patients (39 %) in the OE group were diagnosed and treated for symptomatic stenosis of the anastomosis. Conclusions This first randomized trial shows that MIE is associated with a better mid-term one-year quality of life compared to OE.

Background The presented prospective randomized controlled single-centre study compares the clinical outcome up to 12 months after total hip arthroplasty using a minimally invasive single-incision direct anterior (DAA) and a direct transgluteal lateral approach. Methods A total of 123 arthroplasties were evaluated utilizing the Harris Hip Score (HHS), the extra short musculoskeletal functional assessment questionnaire (XSFMA), the Short Form 36 (SF-36) health survey, a Stepwatch™ Activity Monitor (SAM), and a timed 25 m foot walk (T25-FW). Postoperative x-ray images after THA were reviewed to determine inclination and stem positioning. Results At final follow-up, the XSFMA functional index scores were 10.3 (anterior) and 15.08 (lateral) while the bother index summed up to a score of 15.8 (anterior) and 21.66 (lateral) respectively, thus only differing significantly for the functional index ( p  = 0.040 and p  = 0.056). The SF-36 physical component score (PCS) was 47.49 (anterior) and 42.91 (lateral) while the mental component score (MCS) summed up to 55.0 (anterior) and 56.23 (lateral) with a significant difference evident for the PCS ( p  = 0.017; p  = 0.714). Patients undergoing THA through a DAA undertook a mean of 6402 cycles per day while those who had undergone THA through a transgluteal approach undertook a mean of 5340 cycles per day ( p  = 0.012). Furthermore, the obtained outcome for the T25-FW with 18.4 s (anterior) and 19.75 s (lateral) and the maximum walking distance (5932 m and 5125 m) differed significantly ( p  = 0.046 and p  = 0.045). The average HHS showed no significant difference equaling 92.4 points in the anterior group and 91.43 in the lateral group ( p  = 0.477). The radiographic analysis revealed an average cup inclination of 38.6° (anterior) and 40.28° (lateral) without signs of migration. Conclusion In summary, our outcomes show that after 1 year THA through the direct anterior approach results in a higher patient activity compared to THA utilizing a transgluteal lateral approach while no differences regarding hip function are evident. Trial registration DRKS00014808 (German Clinical Trial Register DRKS); date of registration: 31.05.2018.

We set out to determine whether a minimally invasive approach for one-level instrumented posterior lumbar interbody fusion reduced undesirable changes in the multifidus muscle, compared to a conventional open approach. We also investigated associations between muscle injury during surgery (creatinine kinase levels), clinical outcome and changes in the multifidus at follow-up. We studied 59 patients treated by one team of surgeons at a single institution (minimally invasive approach in 28 and conventional open approach in 31, voluntarily chosen by patients). More than 1 year postoperatively, all the patients were followed up with the visual analogue scale (VAS) and Oswestry disability index (ODI), and 16 patients from each group were evaluated using MRI. This enabled the cross-sectional area (CSA) of lean multifidus muscle, and the T2 signal intensity ratio of multifidus to psoas muscle, to be compared at the operative and adjacent levels. The minimally invasive group had less postoperative back pain ( P  < 0.001) and lower postoperative ODI scores ( P  = 0.001). Multifidus atrophy was less in the minimally invasive group ( P  < 0.001), with mean reductions in CSA of 12.2% at the operative and 8.5% at the adjacent levels, compared to 36.8% and 29.3% in the conventional open group. The increase in the multifidus:psoas T2 signal intensity ratio was similarly less marked in the minimally invasive group where values increased by 10.6% at the operative and 8.3% at the adjacent levels, compared to 34.4 and 22.7% in the conventional open group ( P  < 0.001). These changes in multifidus CSA and T2 signal intensity ratio were significantly correlated with postoperative creatinine kinase levels, VAS scores and ODI scores ( P  < 0.01). The minimally invasive approach caused less change in multifidus, less postoperative back pain and functional disability than conventional open approach. Muscle damage during surgery was significantly correlated with long-term multifidus muscle atrophy and fatty infiltration. Furthermore these degenerative changes of multifidus were also significantly correlated with long-term clinical outcome.

Abstract BACKGROUND In minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF), cage type and position play important roles in fusion achievement and sagittal alignment correction. However, no prospective randomized comparison of the results using different types of cage has been reported to date. OBJECTIVE To compare the radiological and clinical outcomes of unilateral MIS-TLIF using 2 types of cage. METHODS All candidates for single-level MIS-TLIF were randomized into banana-shaped cage and straight-cage groups. Plain radiographs and computed tomography scans were used for assessment of cage positions, fusion status, disc height, segmental lordotic angle, cage subsidence, and pelvic parameters. Clinical outcome was assessed using visual analog scale and Oswestry Disability Index scores. RESULTS Forty-four and 40 consecutive patients were operated on using banana-shaped and straight cages, respectively. Cage position was more anterior and lateral in the straight-cage group and more medial and posterior in the banana-shaped cage group. Solid fusion was achieved in 95.2% and 96.6% of the 2 groups, respectively, at 12 mo. The change in disc height and segmental lordotic angle postoperatively was significantly greater in the banana-shaped cage group. The incidence of subsidence during follow-up was significantly higher in the banana-shaped cage group (P < .04). Clinically, the visual analog scale and Oswestry Disability Index scores decreased significantly after surgery in both groups, with no significant difference between the groups. CONCLUSION Our preliminary outcomes suggest that the subsidence rate may be higher using banana-shaped cages in MIS-TLIF, possibly due to their more medial final position.

Purpose of ReviewThis review aims to clarify the current role of minimally invasive surgery in the treatment of rectal cancer, highlighting short- and long-term outcomes from the latest trials and studies.Recent FindingsData from previous trials has been conflicting, with some failing to demonstrate non-inferiority of laparoscopic surgical resection of rectal cancer compared to an open approach and others demonstrating similar clinical outcomes. Robot-assisted surgery was thought to be a promising solution to the challenges faced by laparoscopic surgery, and even though the only randomized controlled trial to date comparing these two techniques did not show superiority of robot-assisted surgery over laparoscopy, more recent retrospective data suggests a statistically significant higher negative circumferential resection margin rate, decreased frequency of conversion to open, and less sexual and urinary complications.SummaryMinimally invasive surgery techniques for resection of rectal cancer, particularly robot-assisted, offer clear short-term peri-operative benefits over an open approach; however, current data has yet to display non-inferiority in terms of oncological outcomes.

To observe the efficacy and safety of retrograde intrarenal surgery (RIRS) combined with flexible vacuum-assisted ureteral access sheath (FV-UAS) and minimally invasive percutaneous nephrolithotomy (MPCNL) in patients with impacted upper ureteral stones (IUUS). The study included 189 patients, of which 95 were included in the FV-UAS group and 94 in the MPCNL group. The primary study outcome was the stone-free rates (SFRs) on the first postoperative day. Secondary outcomes included the total SFRs 1 month postoperatively, operative time, reduction in hemoglobin levels, length of postoperative hospital stay, improvement in the quality of life as measured by the QoL score, incidence of ureteral stricture at 3 months postoperatively, and any surgery-related complications. There was no obvious difference between two groups in patients’ demographics and preoperative clinical characteristics ( P  > 0.05). The mean decrease in hemoglobin was significantly lower in the FV-UAS group than in the MPCNL group (5.1 vs. 14.7 g/L, P  < 0.001). Similarly, the FV-UAS group had a shorter average hospital stay than the MPCNL group (2.7 vs. 4.9 days, P  < 0.001). However, SFRs at the first postoperative day and 4 weeks postoperatively were statistically similar between the two groups ( P  > 0.05). QoL improvement, measured by the QoL score, was significantly higher in the FV-UAS group than in the MPCNL group (32.5 vs. 27.1, P  < 0.001). At 3 months postoperatively, the difference between two groups in the terms of ureteral stricture was not statistically significant ( P  > 0.05). Notablely, the overall rate of postoperative complications was markedly lower in the FV-UAS group than in the MPCNL group ( P  < 0.001). Our study revealed that RIRS with FV-UAS is a promising approach to treat IUUS, achieving satisfactory SFRs compared to MPCNL and notable improvements in QoL with a low complication rate.

BACKGROUND:Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE:To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS:A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS:Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION:This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. ABBREVIATIONS:EQ-5D, EuroQoL-5DINSITE, Investigation of Sacroiliac Fusion TreatmentMCS, mental component summaryNSM, nonsurgical managementODI, Oswestry Disability IndexPCS, physical component summaryRFA, radiofrequency ablationSF-36, Short Form-36SIJ, sacroiliac jointTTO, time trade-offVAS, visual analog scale

Background This study was a secondary analysis of the ROBOGYN-1004 trial conducted between 2010 and 2015. The study aimed to identify factors that affect postoperative morbidity after either robot-assisted laparoscopy (RL) or conventional laparoscopy (CL) in gynecologic oncology. Methods The study used two-level logistic regression analyses to evaluate the prognostic and predictive value of patient, surgery, and center characteristics in predicting severe postoperative morbidity 6 months after surgery. Results This analysis included 368 patients. Severe morbidity occurred in 49 (28 %) of 176 patients who underwent RL versus 41 (21 %) of 192 patients who underwent CL ( p = 0.15). In the multivariate analysis, after adjustment for the treatment group (RL vs CL), the risk of severe morbidity increased significantly for patients who had poorer performance status, with an odds ratio (OR) of 1.62 for the 1-point difference in the WHO performance score (95 % CI 1.06–2.47; p = 0.027) and according to the type of surgery ( p < 0.001). A focus on complex surgical acts showed significant more morbidity in the RL group than in the CL group at the less experienced centers (OR, 3.31; 95 % CI 1.0–11; p = 0.05) compared with no impact at the experienced centers (OR, 0.87; 95 % CI 0.38–1.99; p = 0.75). Conclusion The findings suggest that the center’s experience may have an impact on the risk of morbidity for patients undergoing complex robot-assisted surgical procedures.

Background Currently, there are three main surgical approaches for resectable esophageal cancer: open transthoracic esophagectomy (OTE), conventional minimally invasive esophagectomy (MIE) and robot-assisted esophagectomy (RAE). Previous studies had demonstrated the better short-term outcomes in MIE or RAE when compared to OTE, respectively. However, to date, no prospective study was designed to compare these two minimally invasive approaches (MIE and RAE). The primary objective of this study is to compare the outcomes on survival, safety and efficacy, quality of life between RAE and MIE in the treatment for resectable esophageal squamous cell carcinoma (ESCC). Methods This study is designed as a multicenter, prospective, randomized, non-inferiority phase III clinical trial, investigating the safety and efficacy of RAE compared with MIE in the treatment of resectable ESCC. Eligible patients are randomly assigned to either RAE ( n  = 180) or MIE ( n  = 180) group. The follow-up visits will be scheduled at 3, 6, 9, and 12 months in the first two years, and then every 6 months until the end of the study. During the follow-up period, clinical data and quality of life questionnaires will be examined. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are 3-year OS, 5-year disease-free survival (DFS), short-term outcomes as well as quality of life. Discussion This is the first prospectively randomized controlled trial designed to compare RAE with MIE as surgical treatment for resectable ESCC. According to our hypothesis, RAE will result in at least similar oncologic outcomes and long-term quality of life, but with a shorter operation time, lower percentage of perioperative complications, lower blood loss, and shorter hospital stay when compared with MIE. This study started in July 2017. Follow-up will terminate after 5 years from the time when the last patient was enrolled. Trial registration ClinicalTrial.gov: NCT03094351 (March 29, 2017). The trial was prospectively registered.