Three-year follow-up of bone status in male patients after bariatric surgery—a prospective single-center cohort study

BackgroundIn women, bariatric surgery (BS) leads to a decline in bone mineral density (BMD) and may ultimately lead to premature osteoporosis. The impact in men is largely unknown.ObjectiveTo assess the effect of BS on bone metabolism in males.SettingSingle-center prospective cohort study.MethodsTwenty-four male BS candidates were prospectively enrolled. Anthropometric characteristics, serum gonadal hormones, markers of bone metabolism, and BMD were measured at baseline, 6-, 12- and 36-months postoperatively.ResultsRoux-en-Y gastric bypass (RYGB) and adjustable gastric banding (AGB) were performed in 15 and 9 patients, respectively. Nineteen patients completed the 3-year follow-up. At 3 years, BMD of the right and left femur had decreased by 9.1 ± 7.2% and 9.4 ± 5.8% for RYGB and by 6.7 ± 3.9% and 4.5 ± 2.8% for AGB. Radius BMD had decreased by 14.0 ± 5.6% for RYGB and 5.9 ± 4.1% for AGB, i.e., significantly stronger for RYGB (P = .006). Serum parathyroid hormone increased in both groups and 13 of 19 patients developed Vitamin D deficiency. A significant increase of the bone resorption marker was seen only during the first year despite continuation of bone loss. Four patients developed de novo osteopenia or osteoporosis. No fractures were observed.ConclusionThere are strong indications that male bone metabolism response after BS differs from female metabolism. The most affected site is the radius. In males, the cause of this BMD loss seems multifactorial, including mechanical unloading, hyperparathyroidism, and hypogonadism. However, clinical relevance remains unknown and therefore studies with longer-term follow-up are necessary.     

Predictors of loss of follow-up in a prospective registry: which patients drop out 12 months after lumbar spine surgery?

Background ContextLong-term patient-reported outcomes (PROMs) are essential in clinical practice and research. Prospective trials and registries often struggle with high rates of loss of follow-up (LOFU), which may bias their findings. Little is known on risk factors for PROM nonresponse, especially for digitally mailed questionnaires.PurposeTo elucidate which patients are at high risk for LOFU by identifying associated predictors.Study DesignAnalysis of a prospective registry.Patient SamplePatients that underwent surgery for degenerative lumbar disease were included.Outcome MeasuresRate of PROM follow-up response at 12 months postoperatively.MethodsPreoperatively and at 12 months postoperatively, patients were asked to complete a range of PROM questionnaires using a web-based tool. All patients who successfully completed their baseline questionnaire were included. Patients were not actively reminded upon nonresponse. Univariate and independent predictors of LOFU at 12 months were identified.ResultsWe included 1,456 patients, of which 861 (59%) were lost to follow-up at 12 months. Univariately, lower age, American Society of Anesthesiologists (ASA) class 1, smoking, lack of prior surgery, higher pain scores and functional disability, and lower quality-of-life were associated with LOFU (all p<.05). Only lower age (OR: 0.98, p=.001), smoking (OR: 1.46, p=.019), lack of prior surgery (OR: 0.59, p=.019), and spondylolisthesis (OR: 0.47, p=.024) independently predicted LOFU.ConclusionsIn a prospective registry of lumbar spine surgery patients based on web-based outcome capturing, younger age, active smoking status, lack of prior surgery, and nonspondylolisthesis surgery were independent predictors of loss of follow-up. In the future, it may become possible to preoperatively identify patients at high-risk for study dropout. As the implementation of prospective registries and the use of automated follow-up methods are on the rise, it is crucial to ensure efficiency and reduce bias of the methods on which all clinical research is based on.     

Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine?: A study of responding and non-responding cohort participants from a clinical spine surgery registry

Background and purpose

Loss to follow-up may bias the outcome assessments of clinical registries. In this study, we wanted to determine whether outcomes were different in responding and non-responding patients who were included in a clinical spine surgery registry, at two years of follow-up. In addition, we wanted to identify risk factors for failure to respond.

Methods

633 patients who were operated for degenerative disorders of the lumbar spine were followed for 2 years using a local clinical spine registry. Those who did not attend the clinic and those who did not answer a postal questionnaire—for whom 2 years of outcome data were missing—and who would be lost to follow-up according to the standard procedures of the registry protocols, were defined as non-respondents. They were traced and interviewed by telephone. Outcome measures were: improvement in health-related quality of life (EQ-5D), leg pain, and back pain; and also general state of health, employment status, and perceived benefits of the operation.

Results

We found no statistically significant differences in outcome between respondents (78% of the patients) and non-respondents (22%). Receipt of postal questionnaires (not being summoned for a follow-up visit) was the strongest risk factor for failure to respond. Forgetfulness appeared to be an important cause. Older patients and those who had complications were more likely to respond.

Interpretation

A loss to follow-up of 22% would not bias conclusions about overall treatment effects and, importantly, there were no indications of worse outcomes in non-respondents.Clinical registries are increasingly being used to monitoring treatment effectiveness and for evaluation of risk factors associated with different outcomes. Loss to follow-up may seriously bias the outcome assessments of clinical registries, and will reduce the statistical power due to smaller sample size (Hunt and White 1998, Hollis and Campbell 1999, Parker and Dewey 2000, Shih 2002, Gluud 2006). Information about outcomes of patients who do not respond at follow-up is valuable both for clinicians and researchers. In limited clinical trials, one can make vigorous attempts to trace and retain cohort members. Such efforts would be too expensive and resource-demanding in large population-based registries (Roder et al. 2005, Fritzell et al. 2006). Thus, researchers who use registry data will have to deal with higher numbers of non-respondents being lost to follow-up (Hunt and White 1998). If the outcomes of non-respondents and respondents are different, wrong conclusions could be drawn about the beneficial and harmful effects of interventions (Gluud 2006). Several studies have indicated that individuals who drop out of clinical trials have worse outcomes than those who do not (Sims 1973, Murray et al. 1997, Norquist et al. 2000, Ludemann et al. 2003, Kim et al. 2004). Different imputation methods have been developed to compensate for missing outcomes (Rubin and Schenker 1991, Little and Yau 1996, Shih and Quan 1997, Wood et al. 2004), but these methods are also susceptible to bias, since they rely on assumptions made about the dropouts (Hollis and Campbell 1999, Shih 2002). Studies of the “true” outcomes in non-respondents may help us to make the right assumptions about outcomes of patients who are lost to follow-up. In addition, to prevent loss to follow-up, we need information about risk factors for failure to respond.Here we present a prospective study of patients who were operated for degenerative disorders of the lumbar spine. We assessed the outcomes of non-respondents, who would be lost to follow-up according to the standard procedures of registry protocols, and compared their outcomes with those of patients who responded, in order to evaluate whether the missing outcomes would bias conclusions about treatment effectiveness. We also wanted to identify risk factors for failure to respond.     

Could a regional trauma system in eastern Switzerland decrease the mortality of blunt polytrauma patients? A prospective cohort study

BACKGROUND: In Europe and Switzerland, hardly any studies have been performed on regional trauma systems. We therefore decided to conduct a prospective study in our region to establish whether an organized trauma system derived from the American model would have a beneficial effect on the survival of blunt polytrauma patients. METHODS: In a prospective observational cohort study conducted between 1990 and 1996, we compared the actual mortality in 280 blunt polytrauma patients admitted directly to our trauma center with the predicted mortality using the A Severity Characterization of Trauma score. The same comparison was made for 190 transferred polytrauma admissions from regional hospitals. Our hypothesis was that for the transferred admissions, the actual mortality would be significantly higher than predicted, but that there would be no difference for the directly admitted patients. Inclusion criteria were blunt trauma of at least two body sites and an Injury Severity Score of 8 or more. RESULTS: Mortality in the patients admitted directly to the trauma center was 11.8% (33 of 280), which was not significantly lower than that for the transferred admissions at 14.2% (27 of 190). There were 10% (3 of 30) more deaths than predicted among the direct admissions (i.e., 3 more deaths; 95% confidence interval, -5.2-11.1; p = NS). Among the transferred admissions, there were 46% (8.6 of 18.4) more deaths than predicted (i.e., 8.6 more deaths; 95% confidence interval, 2.5-14.7; p < 0.05). CONCLUSION: It is likely that a regional trauma system in eastern Switzerland for polytrauma patients with an ISS of 8 or more would have a moderately positive effect on mortality. During the period of observation, transferred admissions from regional hospitals to our trauma center had a 46% higher mortality than predicted. In absolute terms, therefore, with a regional trauma system, it might have been possible to avoid between one death every 2 to 3 years and two to three deaths every year.     

About the quality of prehospital emergency ventilation – a prospective study in trauma patients

Introduction: The prehospitaly initiated endotracheal intubation and controlled ventilation, is especially in multi-system-trauma cases, recognized to be the “gold standard”. Thus especially in view of the increasing demands being placed upon the quality of prehospital emergency treatment in general, the quality of such prehospital induced ventilation, is becoming of increasing importance. Thereby we must take into consideration the limited possabilities, which are afflicted with a high degree of uncertainess, which we have at our disposal to effectively evaluate the efficiency of emergency ventilation. The purpose of our study within a collective of severely traumatized patients, was to determine the quality of prehospitaly induced ventilation with regards to the adequacy of oxygenation and ventilation and as a result of our findings, to identify areas for procedural optimization. Results: The prospective study over an one year period involved n = 104 trauma cases (male: 79; female: 25/age: 39,8 ± 20,8 years/ISS: 28,1 ± 15,3) whose prehospital emergency treatment required and included endotracheal intubation and controlled ventilation. All patients were subject to a prehospital pulse oxymetric monitoring, whereas none were subject to an objectivating apparatus monitoring of ventilation: 94,2 % of the patients were upon admission adequately oxygenated (paO₂ > 80 mmHg); only one patient was hypoxemic (paO₂ < 60 mmHg). 46,2 % were adequately ventilated (paCO₂: 35–45 mmHg), 43,2 % however were hyperventilated (paCO₂ < 35 mmHg), and 10,6 % hypoventilated (paCO₂ > 45 mmHg). A statistical significant relation between hyper-/hypoventilation and the degree of severity of trauma as well as to the individual injury pattern was not evident. However with reference to age: The group of > 60 years of age were significantly more frequently hyperventilated (paCO₂ < 30 mmHg: 31,2 %; p < 0,05). A noteworthy accumulation of hypoventilation was experienced amongst the group of patients, who during the prehospital treatment phase were hemodynamic instable (shock index > 1). Conclusion: In summary it is evident, that as a rule, even very severe traumatized patients can prehospitaly be adequately oxygenated and that such oxygenation can with the assistance of pulse oxymetric monitoring be effectively controlled. Remaining problem is the emergency physicians ability to evaluate and control ventilation. The prehospital determination of minute volume (MV) in accordance with the presently valid recommendation: MV = 100–150 ml/kg body weight, in the majority of trauma cases results in inadequate ventilation. The introduction of an objectifying monitoring method is therefore urgently required.      

Lumbar spine surgery in patients with rheumatoid arthritis (RA): what affects the outcomes?

Background Context

Although the cervical spine is only occasionally involved in rheumatoid arthritis (RA), involvement of the lumbar spine is even less common. A few reports on lumbar spinal stenosis in patients with RA have appeared. Although disc space narrowing occurs in aging, postoperative adjacent segment disease (ASD) in patients with RA has not been subject to much analysis.

Reduction in mortality in severely injured patients following the introduction of the “treatment of patients with severe and multiple injuries” guideline of the German society of trauma surgery – a retrospective analysis of a level 1 trauma center (2010–2012)

Objective

The German society of trauma surgery published the “Treatment of Patients with Severe and Multiple injuries” guideline in 2011. This achieved the highest level of recommendation for guidelines published in Germany. This study investigated if there was an improvement in the survival rates of severed injured patients following the introduction of the guideline in clinical treatment.

Methods

All patients with an injury severity score ≥16 on primary admission to hospital between January 2010 and December 2012 (a total of 373 patients) were included in this study. The data for these patients were collected from the German Trauma Registry and from patients’ hospital records. Patients who were treated in 2010 were compared with patients who were treated in 2011 and 2012, following the introduction of the “treatment of patients with severe and multiple injuries” guideline in the authors’ clinic at the beginning of 2011.

Results

Significant differences were found in ISS, RTS, New ISS, and TRISS between 2010 and 2011/2012. No differences were found in the severity of injury when classified by different body regions. Major differences were found in the total volume replacement, the length of emergency surgery, the length of surgery performed within the first 24 h and the rate of whole-body computed tomography. The mortality rate dropped from 32.48% in 2010 to 18.75% in 2011/2012 (p = 0.003).

Conclusions

The introduction and use of a guideline-based medical care regime for severely injured patients might reduce the rate of mortality.     

Reduction of radiation dose during radiofrequency denervation of the lumbar facet joints using the new targeting system SabreSource™: a prospective study in 20 patients

Background and aims  

Facet joint denervation is a frequently performed technique to treat facet joint syndrome. Most often this technique is used under fluoroscopic guidance implicating high radiation doses for both patients and surgeons. This prospective study was performed to evaluate the effectiveness in reducing radiation dose during radiofrequency ablation therapy of the lumbar facet joints and to evaluate the feasibility and possibilities of the new real time image guidance system SabreSource™.     

Reduction of radiation dose during facet joint injection using the new image guidance system SabreSource™: a prospective study in 60 patients

Interventional procedures are associated with high radiation doses for both patients and surgeons. To reduce the risk from ionizing radiation, it is essential to minimize radiation dose. This prospective study was performed to evaluate the effectiveness in reducing radiation dose during facet joint injection in the lumbar spine and to evaluate the feasibility and possibilities of the new real time image guidance system SabreSource™. A total of 60 patients, treated with a standardized injection therapy of the facet joints L4–L5 or L5–S1, were included in this study. A total of 30 patients were treated by fluoroscopy guidance alone, the following 30 patients were treated using the new SabreSource™ system. Thus a total of 120 injections to the facet joints were performed. Pain, according to the visual analogue scale (VAS), was documented before and 6 h after the intervention. Radiation dose, time of radiation and the number of exposures needed to place the needle were recorded. No significant differences concerning age (mean age 60.5 years, range 51–69), body mass index (mean BMI 26.2, range 22.2–29.9) and preoperative pain (VAS 7.9, range 6–10) were found between the two groups. There was no difference in pain reduction between the two groups (60 vs. 61.5%; P = 0.001) but the radiation dose was significantly smaller with the new SabreSource™ system (reduction of radiation dose 32.7%, P = 0.01; reduction of mean entrance surface dose 32.3%, P = 0.01). The SabreSource™ System significantly reduced the radiation dose received during the injection therapy of the lumbar facet joints. With minimal effort for the setup at the beginning of a session, the system is easy to handle and can be helpful for other injection therapies (e.g. nerve root block therapies).     

Bipolar thermofusion vessel sealing system (TVS) versus conventional vessel ligation (CVL) in thyroid surgery—results of a prospective study

Introduction  

One of the keystones in surgery of the thyroid gland is accurate hemostasis. This can be achieved by conventional ligations or new instruments as harmonic scissors or bipolar devices. In the present study, we report our experience with a new bipolar thermofusion vessel sealing system (TVS) compared to conventional vessel ligation (CVL).     

Internal fixation of acetabular fractures in an older population using the TIMI approach – Midterm results of a prospective study

IntroductionThe incidence of geriatric acetabular fractures continues to increase due to demographic changes. In the elderly, anterior column fractures are common, and standard approaches are associated with a considerable risk for surgery-associated complications. Therefore, a minimally invasive approach was developed in our department. The aim of this study was to examine early and mid-term results regarding the use of this novel two-incision minimally invasive (TIMI) approach in patients aged over 55 years with acetabular fractures.MethodsFrom July 2007 to April 2014, 47 patients aged over 55 years were treated via the TIMI approach; these patients were included in the present prospective study. The patients' characteristics, data, and early phase of care were assessed during acute care. A radiological evaluation comprised pre- and postoperative CT scans and x-rays, including Judet views at follow-up. Follow-up examinations were performed after 6 and 24 months and comprised a clinical and radiological examination and an evaluation of hip function (Harris Hip Score) and health-related quality of life (EQ-5D).ResultsThe mean age of the patients was 74 ± 11 years, with a gender ratio of 35/12 (m/f). The average operation time was 93 ± 30 min, and perioperative blood loss amounted to 858 ± 463 ml. In total, five (11%) complications associated with the operative procedure occurred, and revision surgery was necessary in three patients. We observed no wound infections, abdominal wall hernias or cases of heterotopic ossification in our sample. The Harris Hip Score at six months after surgery was 81, and it slightly improved to 84 after 24 months. The mean EQ5D index was 0.91 at six months after surgery and 0.92 at 24 months after surgery.ConclusionThe TIMI approach represents a valuable alternative to the ilioinguinal and modified Stoppa approach for the treatment of acetabular fractures located in the anterior column, which are often observed in geriatric patients.Level of evidenceTherapeutic Level II (Prospective cohort study).     

Patients’ expectations of spine surgery for degenerative conditions: results from the Canadian Spine Outcomes and Research Network (CSORN)

BACKGROUNDUnderstanding patient expectations is a critical component of patient-centered care; however, little is known about which expectation(s) are most important to patients as they relate to their sense of postoperative success.PURPOSETo investigate patient's preoperative expectations of change in symptoms, function, and well-being resulting from surgical intervention and to examine the associations between sociodemographic, lifestyle, health status, and clinical characteristics with patient outcome expectationsSTUDY DESIGNObservational cross-sectional study.SAMPLEPreoperative data from the Canadian Spine Outcomes and Research Network national registry of patients of patients (n=4,333) undergoing surgery for degenerative spinal conditions between 2012 and 2017.OUTCOME MEASURESPatients reported their expectations as a result of the surgery (0 [no change], 1 [somewhat better], 2 [better] or 3 [much better]) for seven items: leg/arm pain, back/neck pain, independence in everyday activities, sporting activities/recreation, general physical capacity, frequency and quality of social contacts, and mental well-being. Patients also reported the single most important change expected.METHODSData on demographic, lifestyles, health status, clinical factors, and reasons for having surgery were also collected. Factor analysis was used to examine the multidimensionality of expectations. Multivariate linear regression was used to examine factors associated with expectations.RESULTSOver 80% of patients reported expectation for improvements (at least somewhat better) in all items with the exception of social contacts (75.8%). Expectations are multidimensional; a two factor structure emerged indicating two expectation dimensions (pain relief and overall functional well-being). Two expectation scores were calculated corresponding to the two dimensions (0–100), with higher scores reflecting higher expectations. The mean±standard deviation pain relief expectation score was 78.5±24.7 and the mean overall functional well-being expectation score was 69.7±24.4. In multivariate analysis, the variables associated with these dimensions either differed or differed in degree of influence. For example, higher pain and disability scores, thoracolumbar location and diagnosis of spondylolisthesis were associated with higher expectations in both dimensions, while longer disease duration was only associated with lower overall functional well-being expectations. The top three most important expected change items were pain (improvement of leg or arm pain (29.1%)/improvement in back/neck pain (26.0%)), improvement in general capacity/function (21.0%), and improvement of independence in everyday activities (15.9%). Rankings of the most important expected change were similar across sociodemographic, lifestyle, health status, and clinical variables examined.CONCLUSIONSOur findings highlight the need to identify and address specific individual expectations as part of the shared decision-making and presurgery education process.     

Management of 2nd-degree facial burns using the Versajet(®) hydrosurgery system and xenograft: a prospective evaluation of 20 cases

Introduction

There is no single therapeutic scheme for the management of intermediary 2nd-degree facial burns, which can cause problems because of their uncertain course. It is preferable to obtain optimal healing of the face in order to avoid functional or cosmetic sequelae. Some practitioners recommend early excision (first week) of these burns, whereas others prefer to wait and perform surgery later (after 2 weeks). The practice in our burns unit is early surgery (from the first week) associated with hydrosurgical excision and application of a biosynthetic dressing (xenograft). A prospective follow-up of 20 cases was carried out to evaluate the efficacy of our protocol.

Patients and methods

The prospective evaluation was performed with follow-up at 2 weeks and 3, 6 and 12 months. The patients included had intermediary 2nd-degree burns on at least 15% of the face and no life-threatening prognosis. The mean age in our series was 40.5 years (16–72), the mean percentage of burn surface area was 27.75% and the mean percentage of facial burn was 60.75%. Early excision was performed (day 5–10) using the Versajet^® system, which allows tangential water-dissection. Porcine xenograft (E-Z Derm^®) was applied immediately afterwards. Patients whose healing process was not complete at 2 weeks were then scheduled to receive a thin autograft. Patients were followed up 2 weeks, 3, 6 and 12 months after discharge.

Results

Excision was performed at a mean 7.6 days, and mean initial healing time was 13.4 days. In three cases, a full-thickness skin graft was used, whereas healing occurred in the other patients without further grafts. Two patients had functional sequelae (ectropion) corrected later by repair surgery. The course of healing for the other patients proceeded normally.

Discussion

There is no consensus about the management of intermediate depth 2nd-degree facial burns. We chose to perform early surgery using the Versajet^® system, which allows fine, precise excision, leaving nearly all of the healthy tissue in place. The Versajet^® is particularly adapted to facial contours and is clearly more efficacious than the customary dermatomes. The use of a xenograft may augment facial healing while reducing the number of dressings and lessening patient discomfort. Our protocol provides the advantages of early management (limitation of functional sequelae, reduced hospitalization time), while avoiding too extensive or deep an excision through use of the Versajet^®.     

Cleft closure (the Bascom cleft lift) for 714 patients—treatment of choice for complex and recurrent pilonidal disease (a cohort study)

Aim

Pilonidal disease is a benign condition that affects mainly the young. In existing literature, there is no consensus for best treatment, with multiple operative techniques described, some complex, resulting in a high proportion of failure and/or morbidity. The cleft closure (or cleft lift) described by Bascom and Bascom (Arch Surg, 137 , 2002, 1146−50), by comparison, is a simple operation, resulting in healing in the majority and good cosmesis.

Method

This is a single surgeon series, with the aim of evaluating outcomes for consecutive patients who underwent cleft closure surgery at two centres (St Mark's Hospital, London, and Queen Alexandra Hospital, Portsmouth) between 1995 and 2021 for either extensive, complex or recurrent pilonidal disease. Primary study outcomes that were measured included rate of primary healing, time to complete healing and rate of recurrence.

Results

Some 714 patients had a cleft closure of whom 656 had documented follow-up. Primary healing occurred in 60.7% (n = 398) rising to 88.5% by 12 weeks (n = 562) and 91.8% by 16 weeks. The remaining patients healed over the following weeks with only 19 wounds failing to heal completely (3%), requiring further surgery to achieve healing. After complete healing 5.3% of patients developed recurrent disease at a median of 12 months.

Conclusion

Cleft closure is an effective operation for pilonidal disease. Overall, 97% of patients healed without further surgery. A 3% failure rate and 5.3% recurrence rate were observed. This technique could be considered as an alternative procedure to complex flaps or midline excision, in extensive, recurrent and unhealed pilonidal disease.