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Abstract BACKGROUND The use of a subdural drain (SDD) after burr-hole drainage of chronic subdural hematoma (cSDH) reduces recurrence at 6 mo. Subperiosteal drains (SPDs) are considered safer, since they are not positioned in direct contact to cortical structures, bridging veins, or hematoma membranes. OBJECTIVE To investigate whether the recurrence rate after insertion of a SPD is noninferior to the insertion of a more commonly used SDD. METHODS Multicenter, prospective, randomized, controlled, noninferiority trial analyzing patients undergoing burr-hole drainage for cSDH aged 18 yr and older. After hematoma evacuation, patients were randomly assigned to receive either a SDD (SDD-group) or a SPD (SPD-group). The primary endpoint was recurrence indicating a reoperation within 12 mo, with a noninferiority margin of 3.5%. Secondary outcomes included clinical and radiological outcome, morbidity and mortality rates, and length of stay. RESULTS Of 220 randomized patients, all were included in the final analysis (120 SPD and 100 SDD). Recurrence rate was lower in the SPD group (8.33%, 95% confidence interval [CI] 4.28-14.72) than in the SDD group (12.00%, 95% CI 6.66-19.73), with the treatment difference (3.67%, 95% CI -12.6-5.3) not meeting predefined noninferiority criteria. The SPD group showed significantly lower rates of surgical infections (P = .0406) and iatrogenic morbidity through drain placement (P = .0184). Length of stay and mortality rates were comparable in both groups. CONCLUSION Although the noninferiority criteria were not met, SPD insertion led to lower recurrence rates, fewer surgical infections, and lower drain misplacement rates. These findings suggest that SPD may be warranted in routine clinical practice Graphical Abstract Graphical Abstract

Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II–III haemorrhoids. This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II–III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716. From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42–3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference −1·2, 95% CI −1·8 to −0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference −1·5, −2·0 to −1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics). Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL. NIHR Health Technology Assessment programme.

Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

PurposeImmediate breast reconstruction (IBR) at the time of mastectomy is gaining popularity, as studies show no negative impact on recurrence or patient survival, but better aesthetic outcome, less psychological distress and lower treatment costs. Using the largest database available in Europe, the presented study compared outcomes and complications of IBR vs. delayed breast reconstruction (DBR).Methods3926 female patients underwent 4577 free DIEP-flap breast reconstructions after malignancies in 22 different German breast cancer centers. The cases were divided into two groups according to the time of reconstruction: an IBR and a DBR group. Surgical complications were accounted for and the groups were then compared.ResultsOverall, the rate of partial-(1.0 versus 1.2 percent of cases; p = 0.706) and total flap loss (2.3 versus 1.9 percent of cases; p = 0.516) showed no significant difference between the groups. The rate of revision surgery was slightly, but significantly lower in the IBR group (7.7 versus 9.8 percent; p = 0.039). Postoperative mobilization was commenced significantly earlier in the IBR group (mobilization on postoperative day 1: 82.1 versus 68.7 percent; p < 0.001), and concordantly the mean length of hospital stay was significantly shorter (7.3 (SD3.7) versus 8.9 (SD13.0) days; p < 0.001).ConclusionIBR is feasible and cannot be considered a risk factor for complications or flap outcome. Our results support the current trend towards an increasing number of IBR. Especially in times of economic pressure in health care, the importance of a decrease of hospitalization cannot be overemphasized.

Abstract BackgroundGiven revision or conversion surgery is required in up to 60% of patients who had adjustable gastric band (LAGB), we compared safety and efficacy of sleeve gastrectomy (SG) and one anastomosis gastric bypass (OAGB) as conversion surgical procedures in patients with suboptimal response or weight recurrence following LAGB.MethodsConversion surgery was performed in 335 patients between 2016 and 2020. Weight loss, early and late-stage complications, and comorbidity outcomes were reviewed and analyzed.ResultsOne hundred and sixty-three patients underwent cSG (BMI: 38.3 ± 8.3 kg/m2), and 172 patients underwent cOAGB (BMI: 45.2 ± 9.3 kg/m2). Percent total body weight loss (%TWL) was 28.7 ± 9.9% at 12 months, 30.3 ± 12.8% at 2 years, 31.0 ± 14.5% at 3 years, and 31.1 ± 14.7% at 4 years following OAGB, which was significantly higher than SG; 18.4 ± 8.7%, 18.8 ± 9.8%, 19.3 ± 11.1%, and 16.9 ± 10.9%, respectively (p < 0.0001). Remission of comorbidities, regardless of conversion procedure type, was 20.8% for hypertension (HT), 52% for dyslipidemia (DLD), 60% for type 2 diabetes (DM), 64% for non-alcoholic steatohepatitis (NASH), and 76% for insulin resistance (IR).There were no leaks or deaths following SG or OAGB. A twofold greater frequency of complications was seen in the OAGB group vs SG group (15.1% and 6.7%, respectively).ConclusionSignificant weight loss, acceptable complication rates, and similar remission of comorbidities were seen regardless of the type of conversion procedure. Prospective randomized clinical trials are recommended for further elucidation of long-term outcomes.

Purpose Two non-restorative options for low rectal cancer not invading the sphincter are the low Hartmann’s procedure (LH) or intersphincteric proctectomy (IP). The aim of this study was to compare postoperative morbidity with emphasis on pelvic abscesses after LH and IP. Methods All patients that had LH or IP for low rectal cancer were included in three centres between 2008 and 2014 in this retrospective cohort study. Follow-up was performed for at least 12 months. Results A total of 52 patients were included: 40 LH and 12 IP. Median follow-up was 29 months (IQR 23). There were no differences between groups in gender, age and ASA classification. Seven patients in the LH group (18%) and four patients in the IP group (33%) developed a complication within 30-day postoperative with a Clavien-Dindo classification grade III or higher ( P  = 0.253). Four out of 40 patients (10%) in the LH group and two out of 12 patients (17%) in the IP group developed a pelvic abscess ( P  = 0.612). Reinterventions were performed in 11 (28%) patients in the LH group and five (42%) patients in the IP group ( P  = 0.478), with a total number of reinterventions of 13 and 20, respectively. Six and 15 interventions were related to pelvic abscesses, respectively. Conclusion Pelvic abscesses seem to occur in a similar rate after both LH and IP. Previous reports from the literature suggesting that IP might be associated with less infectious pelvic complications compared to LH are not supported by this study, although numbers are small.

Background Obesity is a leading cause of morbidity and healthcare utilization. At the moment, the best treatment for obesity has shown to be laparoscopic gastric bypass. However, about a quarter of the patients experience substantial weight regain, which is difficult to treat, as revision surgery has higher risks than primary procedures. Endoscopic procedures, such as endoscopic suturing, are effective, safe and less invasive in addressing weight regain. Methods We conducted a retrospective analysis on 22 consecutive patients operated between 2011 and 2013 who had a significant weight regain after RYGB (mean follow-up 22 months), in order to evaluate the long-term outcomes of endoscopic gastro-jejunal revision after weight regain post-bypass surgery. Mucosal ablation around the anastomosis was performed in all patients, and the endoscopic suturing device was used to perform suture stoma reduction. We also evaluated, in a group of 11 patients, the effect of combining sclerotherapy and endoscopic suturing. Results We showed good efficacy of the endoluminal procedure, with 100 % of patients achieving weight loss. Maximum weight loss was noted at a mean of 18-month follow-up (average of 60.3 % excess weight loss; n  = 19), while the mean weight loss regained percentage was 5 % ± 39. 4/22 patients (all four in non-sclerotherapy group, all of them had an anastomosis >10 mm) regained some of this lost weight by the time of the longest follow-up. There was an actual correlation between final stoma diameter (<10 mm) and weight loss. Conclusions A larger randomized sample of patients with a longer follow-up would be needed to support the effectiveness of the combination of the two therapies. Although almost 20 % of the patients regained weight during the follow-up period, the endoluminal approach offers the advantage of being repeatable after weight regain without adding morbidity risks.

Background The number of revision rotator cuff cases is increasing. The literature is lacking guidance or biomechanical evaluation for fixation strength in a revision case scenario. Therefore, the aim of the study was to provide biomechanical data investigating primary fixation strength of a transosseous technique after anchor pullout failure of a single row reconstruction. It was hypothesized that an arthroscopic transosseous repair system as a procedure for rotator cuff revisions is providing equivalent stability compared to a primary single row suture anchor fixation due to change of fixation site. Methods Eight matched pairs ( n  = 16) of fresh frozen human shoulders were tested. The paired specimen shoulders were randomly divided into two repair groups ( A single row and B primary transosseous repair). The potted specimens were mounted onto the Servohydraulic test system. Both groups were tested under cyclic loading followed by load to failure testing. Suture anchor repair shoulders (group A) that were tested to failure underwent a revision transosseous repair and were subsequently tested again using the same setup and protocol (group C). Results The mean native footprint areas did not show a significant difference between groups. The reconstructed footprint area showed a significantly greater coverage in favor of the transosseous repair. Ultimate load to failure of reconstructions with the primary anchor fixation (344.73 N ± 63.19) and the primary transosseous device (375.36 N ± 70.27) was not significantly higher compared to the revision repair (332.19 N ± 119.01 p  = 0.45, p  = 0.53). Conclusion The tested transosseous anchor device is a suitable option to widely used suture anchors, providing equivalent fixation properties even in a revision case scenario. Level of evidence Basic Science Study, Biomechanics.

ObjectivesUnderstanding patients’ preferences for treatment is crucial to provision of good care and shared decisions, especially when more than one treatment option exists for a given condition. One such condition is infection of the area around the prosthesis after hip replacement, which affects between 0.4% and 3% of patients. There is more than one treatment option for this major complication, and our study aimed to assess the value that patients place on aspects of revision surgery for periprosthetic hip infection.DesignWe identified four attributes of revision surgery for periprosthetic hip infection. Using a discrete choice experiment (DCE), we measured the value placed on each attribute by 57 people who had undergone either one-stage or two-stage revision surgery for infection.SettingThe DCE was conducted with participants from nine National Health Service hospitals in the UK.ParticipantsAdults who had undergone revision surgery for periprosthetic hip infection (N=57).ResultsOverall, the strongest preference was for a surgical option that resulted in no restrictions on engaging in valued activities after a new hip is fitted (β=0.7). Less valued but still important attributes included a shorter time taken from the start of treatment to return to normal activities (6 months; β=0.3), few or no side effects from antibiotics (β=0.2), and having only one operation (β=0.2).ConclusionsThe results highlight that people who have had revision surgery for periprosthetic hip infection most value aspects of care that affect their ability to engage in normal everyday activities. These were the most important characteristics in decisions about revision surgery.

BackgroundDespite the advantages of autologous fat transfer to the breast, there are many complications after the surgery, such as oil cysts, calcification and palpable breast nodules. The fat purification process is a key step to reduce those complications, but there is currently no standard processing method. This study was designed to compare the incidence of fat necrosis after autologous fat grafting to the breast with low-speed centrifugation and sedimentation.MethodsThis study analyzed 100 patients (167 breasts) who underwent autologous fat grafts to the breasts from January, 2015 to March, 2017. Patients were divided into two groups randomly, low-speed centrifugation (800 r/min) and sedimentation (15 min). Postoperative fat necrosis such as oil cysts and palpable breast nodules was measured using physical examination and breast ultrasound 3 months after the surgery. The number and the diameter of the fat necroses were detected.ResultsA total of 100 patients (167 breasts) were included this research. There were 21 breasts with clinically palpable nodules (12.57%); fifteen (19.48%) were in the low-speed centrifugation group and six (6.67%) were in the sedimentation group (p < 0.05). According to postoperative breast ultrasounds, there were 83 breasts with hypoechoic cyst formations (49.7%); forty-five (58.44%) in the low-speed centrifugation group and 38 (42.22%) in the sedimentation group (p < 0.05). A positive correlation between the number of operative sessions and fat necrosis was found out.ConclusionAlthough low-speed centrifugation could achieve higher fat purification efficacy when compared with sedimentation, it causes more fat necrosis than sedimentation, such as clinically palpable nodules and subclinical nodules, especially in patients who had a history of breast surgery and those who needed more than one fat grafting session.Level of Evidence IIIThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.