Abstract Background Context Transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are both frequently used as surgical treatment for lumbar spondylolisthesis. Due ...to the unilateral transforaminal route to the intervertebral space used in TLIF, opposed to the bilateral route used in PLIF, TLIF could be associated with fewer complications, shorter duration of surgery, and less blood loss, while effectiveness of both techniques on back and/or leg pain is equal. Purpose To compare the effectiveness of both TLIF and PLIF in reducing disability, and to compare the intra- and postoperative complications of both techniques in patients with lumbar spondylolisthesis. Study Design/Setting A systematic literature review and meta-analysis was carried out. Methods We conducted a Medline (using Pubmed), Embase (using Ovid), Cochrane Library, Current Controlled Trials, ClinicalTrials.gov and NHS Centre for Review and Dissemination search for studies reporting TLIF, PLIF, lumbar spondylolisthesis and disability, pain, complications, duration of surgery and estimated blood loss. A meta-analysis was performed to compute pooled estimates of differences between TLIF and PLIF. Forest plots were constructed for each analysis group. Results 192 studies were identified, nine studies were included (one randomized controlled trial and eight case series), including 990 patients (450 TLIF and 540 PLIF). Pooled mean difference in postoperative ODI scores between TLIF and PLIF was -3.46 (95% CI -4.72, -2.20, p = <0.001). Pooled mean difference in postoperative VAS scores was -0.05 (95% CI -0.18, 0.09, p = 0.480). The overall complication rate for TLIF was 8.7% (range 0-25%), for PLIF 17.0% (range 4.7-28.8%), pooled odds ratio was 0.47 (95% CI 0.28, 0.81, p = 0.006). The average duration of surgery was 169 minutes for TLIF and 190 minutes for PLIF (mean difference -20.1, 95% CI -33.5, -6.6, p = 0.003). Estimated blood loss was 350 ml for TLIF and 418 ml for PLIF (mean difference -43.9 ml, 95% CI -71.2, -16.6, p = 0.002). Conclusions TLIF has advantages over PLIF in complication rate, blood loss and operation duration. Clinical outcome is similar, with a slightly lower postoperative ODI score for TLIF.
Purpose
The number of breast cancer survivors continues to grow. Due to refinements in operating techniques, autologous breast reconstruction has become part of standard care. Impaired sensation ...remains a debilitating side effect with a significant impact on the quality of life. Microsurgical nerve coaptation of a sensory nerve has the potential to improve sensation of the reconstructed breast. This study investigates the effect of improved sensation of the reconstructed breast on the quality of life in breast cancer survivors.
Methods
A retrospective cohort study was performed in the Maastricht University Medical Center. Patients undergoing a DIEP flap breast reconstruction between January 2015 and January 2016 were included. The primary outcome was quality of life (BREAST-Q domain ‘physical well-being of the chest’). The Semmes–Weinstein monofilaments were used for objective sensation measurement of the reconstructed breast(s).
Results
Eighteen patients with and 14 patients without nerve coaptation responded. Nipple reconstruction was the only characteristic that differed statistically significant between both groups (
p
= 0.04). The BREAST-Q score for the domain physical well-being of the chest was 77.89 ± 18.89 on average in patients with nerve coaptation and 66.21 ± 18.26 in patients without nerve coaptation (
p
= 0.09). Linear regression showed a statistically significant relation between objectively measured sensation and BREAST-Q score for the domain physical well-being of the chest with a regression coefficient of − 13.17 ± 3.61 (
p
< 0.01).
Conclusions
Improved sensation in the autologous reconstructed breast, with the addition of microsurgical nerve coaptation, has a statistical significant positive impact on the quality of life in breast cancer survivors according to the BREAST-Q.
IMPORTANCE: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. OBJECTIVE: To investigate quality of life (QoL) ...among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). DESIGN, SETTING, AND PARTICIPANTS: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. INTERVENTIONS: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. MAIN OUTCOMES AND MEASURES: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. RESULTS: A total of 193 female patients (mean SD age, 49.2 10.6 years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean SD age, 49.3 10.3 years) and 80 in the IBR group (mean age, 49.1 11.0 years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 111.4 mL; IBR: 384.1 86.6 mL). No differences in oncological serious adverse events were found. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02339779
Previous studies have shown that opioids can reduce chronic breathlessness in advanced disease. However, physicians remain reluctant to prescribe opioids for these patients, commonly due to fear of ...respiratory adverse effects. The aim of this study was to systematically review reported respiratory adverse effects of opioids in patients with advanced disease and chronic breathlessness.PubMed, Embase, the Cochrane Central Register of Controlled Trials, CINAHL, ClinicalTrials.gov and the reference lists of relevant systematic reviews were searched. Two independent researchers screened against predefined inclusion criteria and extracted data. Meta-analysis was conducted where possible.We included 63 out of 1990 articles, describing 67 studies. Meta-analysis showed an increase in carbon dioxide tension (0.27 kPa, 95% CI 0.08-0.45 kPa,) and no significant change in oxygen tension and oxygen saturation (both p>0.05). Nonserious respiratory depression (definition variable/not stated) was described in four out of 1064 patients. One cancer patient pretreated with morphine for pain needed temporary respiratory support following nebulised morphine for breathlessness (single case study).We found no evidence of significant or clinically relevant respiratory adverse effects of opioids for chronic breathlessness. Heterogeneity of design and study population, and low study quality are limitations. Larger studies designed to detect respiratory adverse effects are needed.
Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved ...outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. TBIicp patients were randomized to either the Brain Trauma Foundation (BTF) guideline CPP target range (control group) or to the individualized CA-guided CPP targets (intervention group). CPP targets were guided by six times daily software-based alerts for up to 5 days. The primary feasibility end-point was the percentage of time with CPP concordant (±5 mm Hg) with the set CPP targets. The main secondary safety end-point was an increase in therapeutic intensity level (TIL) between the control and intervention group. Twenty-eight patients were randomized to the control and 32 patients to the intervention group. CPP in the intervention group was in the target range for 46.5% (interquartile range, 41.2-58) of the monitored time, significantly higher than the feasibility target specified in the published protocol (36%;
< 0.001). There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes.
The primary objective of this study is to identify which modifiable and non-modifiable factors are independent predictors of the development of chronic pain in patients with acute- or subacute ...nonspecific idiopathic, non-traumatic neck pain, and secondly, to combine these to develop and internally validate a prognostic prediction model.
A prospective cohort study will be conducted by physiotherapists in 30 primary physiotherapy practices between January 26, 2020, and August 31, 2022, with a 6-month follow-up until March 17, 2023. Patients who consult a physiotherapist with a new episode of acute- (0 to 3 weeks) or subacute neck pain (4 to 12 weeks) will complete a baseline questionnaire. After their first appointment, candidate prognostic variables will be collected from participants regarding their neck pain symptoms, prior conditions, work-related factors, general factors, psychological and behavioral factors. Follow-up assessments will be conducted at six weeks, three months, and six months after the initial assessment. The primary outcome measure is the Numeric Pain Rating Scale (NPRS) to examine the presence of chronic pain. If the pain is present at six weeks, three months, and six months with a score of NPRS ≥3, it is classified as chronic pain. An initial exploratory analysis will use univariate logistic regression to assess the relationship between candidate prognostic factors at baseline and outcome. Multiple logistic regression analyses will be conducted. The discriminative ability of the prognostic model will be determined based on the Area Under the receiver operating characteristic Curve (AUC), calibration will be assessed using a calibration plot and formally tested using the Hosmer and Lemeshow goodness-of-fit test, and model fit will be quantified as Nagelkerke's R2. Internal validation will be performed using bootstrapping-resampling to yield a measure of overfitting and the optimism-corrected AUC.
The results of this study will improve the understanding of prognostic and potential protective factors, which will help clinicians guide their clinical decision making, develop an individualized treatment approach, and predict chronic neck pain more accurately.
Background
Breast cancer will affect one in eight women during their lifetime. The opportunity to restore the removed tissue and cosmetic appearance is provided by reconstructive breast surgery ...following skin‐sparing mastectomy (SSM). Mastectomy skin flap necrosis (MSFN) is a common complication following SSM breast reconstruction. This postoperative complication can be prevented by intraoperative assessment of mastectomy skin flap viability and intervention when tissue perfusion is compromised. Indocyanine green fluorescence angiography is presumed to be a better predictor of MSFN compared to clinical evaluation alone.
Objectives
To assess the effects of indocyanine green fluorescence angiography (ICGA) for preventing mastectomy skin flap necrosis in women undergoing immediate breast reconstruction following skin‐sparing mastectomy.
To summarise the different ICGA protocols available for assessment of mastectomy skin flap perfusion in women undergoing immediate breast reconstructions following skin‐sparing mastectomy.
Search methods
We searched the Cochrane Breast Cancer Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL; Issue 3, 2019), MEDLINE, Embase, the World Health Organization's International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov in April 2019. In addition, we searched reference lists of published studies.
Selection criteria
We included studies that compared the use of ICGA to clinical evaluation to assess mastectomy skin vascularisation and recruited women undergoing immediate autologous or prosthetic reconstructive surgery following SSM for confirmed breast malignancy or high risk of developing breast cancer.
Data collection and analysis
Two review authors independently assessed the risk of bias of the included nonrandomised studies and extracted data on postoperative outcomes, including postoperative MSFN, reoperation, autologous flap necrosis, dehiscence, infection, haematoma and seroma, and patient‐related outcomes. The quality of the evidence was assessed using the GRADE approach and we constructed two 'Summary of finding's tables: one for the comparison of ICGA to clinical evaluation on a per patient basis and one on a per breast basis.
Main results
Nine nonrandomised cohort studies met the inclusion criteria and involved a total of 1589 women with 2199 breast reconstructions. We included seven retrospective and two prospective cohort studies. Six studies reported the number of MSFN on a per breast basis for a total of 1435 breasts and three studies reported the number of MSFN on a per patient basis for a total of 573 women. Five studies reported the number of other complications on a per breast basis for a total of 1370 breasts and four studies reported the number on a per patient basis for a total of 613 patients. Therefore, we decided to pool data separately.
Risk of bias for each included nonrandomised study was assessed using the Newcastle‐Ottawa Scale for cohort studies. There was serious concern with risk of bias due to the nonrandomised study design of all included studies and the low comparability of cohorts in most studies. The quality of the evidence was found to be very low, after downgrading the quality of evidence twice for imprecision based on the small sample sizes and low number of events in the included studies.
Postoperative complications on a per patient basis
We are uncertain about the effect of ICGA on MSFN (RR 0.79, 95% CI 0.40 to 1.56; three studies, 573 participants: very low quality of evidence), infection rates (RR 0.91, 95% CI 0.60 to 1.40; four studies, 613 participants: very low quality of evidence), haematoma rates (RR 0.87, 95% CI 0.30 to 2.53; two studies, 459 participants: very low quality of evidence) and seroma rates (RR 1.68, 95% CI 0.41 to 6.80; two studies, 408 participants: very low quality of evidence) compared to the clinical group. We found evidence that ICGA may reduce reoperation rates (RR 0.50, 95% CI 0.35 to 0.72; four studies, 613 participants: very low quality of evidence). One study considered dehiscence as an outcome. In this single study, dehiscence was observed in 2.2% of participants (4/184) in the ICGA group compared to 0.5% of participants (1/184) in the clinical group (P = 0.372). The RR was 4.00 (95% CI 0.45 to 35.45; one study; 368 participants; very low quality of evidence).
Postoperative complications on a per breast basis
We found evidence that ICGA may reduce MSFN (RR 0.62, 95% CI 0.48 to 0.82; six studies, 1435 breasts: very low quality of evidence), may reduce reoperation rates (RR 0.65, 95% CI 0.47 to 0.92; five studies, 1370 breasts: very low quality of evidence) and may reduce infection rates (RR 0.65, 95% CI 0.44 to 0.97; five studies, 1370 breasts: very low quality of evidence) compared to the clinical group. We are uncertain about the effect of ICGA on haematoma rates (RR 1.53, CI 95% 0.47 to 4.95; four studies, 1042 breasts: very low quality of evidence) and seroma rates (RR 0.71, 95% CI 0.37 to 1.35; two studies, 528 breasts: very low quality of evidence).
None of the studies reported patient‐related outcomes.
ICGA protocols: eight studies used the SPY System and one study used the Photodynamic Eye imaging system (PDE) to assess MSFN. ICGA protocols in the included studies were not extensively described in most studies.
Authors' conclusions
Although mastectomy skin flap perfusion is performed more frequently using ICGA as a helpful tool, there is a lack of high‐quality evidence in the context of randomised controlled trials. The quality of evidence in this review is very low, since only nonrandomised cohort studies have been included. With the results from this review, no conclusions can be drawn about what method of assessment is best to use during breast reconstructive surgery. High‐quality randomised controlled studies that compare the use of ICGA to assess MSFN compared to clinical evaluation are needed.
Objective
To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP‐Q stage ≥2 vaginal vault prolapse ...(VVP).
Design
Multicentre randomised controlled trial (RCT) and prospective cohort study alongside.
Setting
Seven non‐university teaching hospitals and two university hospitals in the Netherlands.
Population
Patients with symptomatic post‐hysterectomy vaginal vault prolapse, requiring surgical treatment.
Methods
Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP‐Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively.
Main outcome measures
Primary outcome was disease‐specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri‐operative data, complications and sexual function.
Results
A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease‐specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129).
Conclusions
LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow‐up period of 12 months.
Background
During extracorporeal life support (ECLS), bleeding is one of the most frequent complications, associated with high morbidity and increased mortality, despite continuous improvements in ...devices and patient care. Risk factors for bleeding complications in veno‐venous (V‐V) ECLS applied for respiratory support have been poorly investigated.
We aim to develop and internally validate a prediction model to calculate the risk for bleeding complications in adult patients receiving V‐V ECLS support.
Methods
Data from adult patients reported to the extracorporeal life support organization (ELSO) registry between the years 2010 and 2020 were analyzed. The primary outcome was bleeding complications recorded during V‐V ECLS. Multivariable logistic regression with backward stepwise elimination was used to develop the predictive model. The performance of the model was tested by discriminative ability and calibration with receiver operating characteristic curves and visual inspection of the calibration plot.
Results
In total, 18 658 adult patients were included, of which 3 933 (21.1%) developed bleeding complications. The prediction model showed a prediction of bleeding complications with an AUC of 0.63. Pre‐ECLS arrest, surgical cannulation, lactate, pO2, HCO3, ventilation rate, mean airway pressure, pre‐ECLS cardiopulmonary bypass or renal replacement therapy, pre‐ECLS surgical interventions, and different types of diagnosis were included in the prediction model.
Conclusions
The model is based on the largest cohort of V‐V ECLS patients and reveals the most favorable predictive value addressing bleeding events given the predictors that are feasible and when compared to the current literature. This model will help identify patients at risk of bleeding complications, and decision making in terms of anticoagulation and hemostatic management.
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