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Background Immediate lymphatic reconstruction (ILR) has been proposed to decrease lymphedema rates. The primary aim of our study was to determine whether ILR decreased the incidence of lymphedema in patients undergoing axillary lymph node dissection (ALND). Methods We conducted a two-site pragmatic study of ALND with or without ILR, employing surgeon-level cohort assignment, based on breast surgeons’ preferred standard practice. Lymphedema was assessed by limb volume measurements, patient self-reporting, provider documentation, and International Classification of Diseases, Tenth Revision (ICD-10) codes. Results Overall, 230 patients with breast cancer were enrolled; on an intention-to-treat basis, 99 underwent ALND and 131 underwent ALND with ILR. Of the 131 patients preoperatively planned for ILR, 115 (87.8%) underwent ILR; 72 (62.6%) were performed by one breast surgical oncologist and 43 (37.4%) by fellowship-trained microvascular plastic surgeons. ILR was associated with an increased risk of lymphedema when defined as ≥10% limb volume change on univariable analysis, but not on multivariable analysis, after propensity score adjustment. We did not find a statistically significant difference in limb volume measurements between the two cohorts when including subclinical lymphedema (≥5% inter-limb volume change), nor did we see a difference in grade between the two cohorts on an intent-to-treat or treatment received basis. For all patients, considering ascertainment strategies of patient self-reporting, provider documentation, and ICD-10 codes, as a single binary outcome measure, there was no significant difference in lymphedema rates between those undergoing ILR or not. Conclusion We found no significant difference in lymphedema rates between patients undergoing ALND with or without ILR.

Objective The study attempted to explore the postoperative pain control of ultrasound-guided iliac fascia and trigeminus block anesthesia among patients undergoing free flap reconstruction for head-and-neck tumors. Methods This research implemented a prospective, double-blinded, randomized, and placebo-controlled clinical trial. Patients between 18 and 85 years who had accepted a radical head-and-neck tumor resection while simultaneously undergoing the vascularized anterolateral femoral free flap reconstruction for the surgical coloboma were recruited. The subjects were randomly divided into nerve block and blank groups. Faciocervical pain while speaking was the primary outcome variable. It was measured using the visual analog scale (VAS) during the perioperative period up to postoperative 7 days. Descriptive statistics and logistic regression analysis were performed. The data were analyzed using the Mann–Whitney U test, linear mixed-effects model, chi-square test, and Fisher’s exact test. The statistically significant level was set at P  < 0.05. Results The sample comprised 145 subjects with a mean age of 58.4 (SD = 12.7), 102 (70.3%) males. There were 71 (49.0%) and 74 (51.0%) participants in the nerve block and blank groups. Nerve block anesthesia reduced postoperative pain, depicted by VASS (0.99 ± 1.72 P  < 0.0001). The out-of-bed mobilization started before within the nerve block group (47.45 ± 19.68 P  = 0.017). The high expression of IL-6 could decrease the efficacy of this protocol ( P  = 0.0176). Conclusion Ultrasound-guided iliac fascia combined with trigeminus block anesthesia is an effective method for pain management in patients who underwent head-and-neck tumor surgery in conjunction with the simultaneous repair using the vascularized anterolateral femoral free flap. Trial registration The Institutional Ethics Review Board approved the study and retrospectively registered it with the Chinese Clinical Trial Registry at January 10, 2024 (ChiCTR2400079720).

Background There are two types of methods of creating a gastric conduit after esophagectomy for patients with esophageal cancer: narrow gastric tube reconstruction or whole stomach reconstruction. Whole stomach reconstruction with good blood perfusion was reported in a prospective cohort study to be safe and that it has the possibility to prevent anastomotic leakage (AL). We therefore planned a randomized controlled phase III study to investigate the superiority of whole stomach reconstruction over narrow gastric tube reconstruction after esophagectomy for esophageal cancer. Methods This is a single center, two-arm, open-label, randomized phase III trial. We calculated that 65 patients in each arm of this study and total study population of 130 patients are required according to our historical data on narrow gastric tube reconstruction and prospective data on whole stomach reconstruction. In the narrow gastric tube group, a 3.5-cm-wide gastric tube is made along the greater curvature of the stomach using linear staplers. Otherwise, in the whole stomach group, after the lymphadenectomy of the lesser curvature and No.2, the stomach is cut just below the esophagogastric junction using a linear stapler. The primary endpoint of this study is the incidence of AL. Secondary endpoints are the occurrence rate of anastomotic stenosis, the occurrence rate of pneumonia, the occurrence rate of all postoperative complications, the occurrence rate of reflux esophagitis, quality of life evaluation by EORTC QLQ-C30 and EORTC OES-18, nutritional evaluation, the amount of blood loss, postoperative hospital stays, and blood flow evaluation. Complications are evaluated using the Clavien-Dindo classification (version 2.0), and those of grade II or higher are considered to be postoperative complications. Discussion If the optimal method for creating a gastric conduit after esophagectomy is clarified, it may be possible to contribute to improving short-term and long-term surgical outcomes for patients undergoing surgery for esophageal cancer. Trial registration The protocol of ATHLETE trial was registered in the UMIN Clinical Trials Registry as UMIN000050677 ( http://www.umin.ac.jp/ctr/index.htm ). Date of registration: March 26, 2023. Date of first participant enrollment: March 27, 2023.

Background To analyze the effects of pressure-controlled volume-guaranteed ventilation (PCV-VG) and volume-controlled ventilation (VCV) on postoperative pulmonary complications (PPCs) after oral and maxillofacial surgery with free flap reconstruction. Methods This was a prospective, randomized, controlled trial comparing two intraoperative ventilation strategies. Two hundred and forty patients who underwent oral and maxillofacial surgery with free flap reconstruction were randomly allocated to either VCV group ( n  = 120) or the PCV-VG group ( n  = 120). After induction of anesthesia, for both modes of ventilation, the target tidal volume (VT) was 6 mL/kg and the respiratory rate was adjusted to avoid hypercarbia. The primary outcome was a composite of postoperative pulmonary complications within the first seven postoperative days. The peak and mean inspiratory pressures and dynamic compliance were recorded at T1(the time after the patients entered the operation room), T2 (the time of skin incision), T3 (the time when anastomosing blood vessels), T4 (the time of closure of the incision). And oxygenation index (OI) and arterial partial pressure of oxygen (PaO 2 ) / fraction of inspiration oxygen (FiO 2 ) were calculated and recorded at T1 and T4. Results The two groups had similar characteristics at baseline. 26.7% patients in PCV-VG group, and 34.2% patients in VCV group experienced PPCs within the first 7 days after surgery ( P  = 0.051). In the first 7 days after surgery, the PCV-VG group had a better postoperative survival probability, but without significant statistical differences (Log-rank test, P  = 0.056). But in tracheotomy patients, PCV-VG group had a lower incidence of PPCs ( P  < 0.05). In addition, the PCV-VG group had a shorter length of stay in hospital after surgery (9 days vs. 10 days, P  = 0.041). Furthermore, PCV-VG group had significantly lower peak inspiratory pressure and greater dynamic compliance than VCV group ( P  < 0.05). At the same time, OI and PaO 2 /FiO 2 were better in PCV-VG group ( P  < 0.05). Conclusions For patients undergoing oral and maxillofacial surgery with free flap reconstruction who were at intermediate or high risk of developing PPCs, PCV-VG could shorten the length of stay in hospital and showed a trend toward being superior to VCV in its ability to provide ventilation with lower peak inspiratory pressure, greater dynamic compliance, and better oxygenation. Meanwhile, in tracheotomy patients, the PCV-VG group had a lower incidence of PPCs. Trial registration Chinese Clinical Trial Registry, www.chictr.org.cn , number: ChiCTR2200060865; Registered on June 12, 2022.

IntroductionAbdominal wall hernias are a common source of morbidity and mortality. The use of biological mesh has become an important adjunct in successful abdominal wall reconstruction. There are a variety of biological mesh products available; however, there is limited evidence supporting the use of one type over another. This study aims to compare the performance (eg, the rate of hernia recurrence) of either a crosslinked biological mesh product or a non-crosslinked product in patients undergoing abdominal wall reconstruction.Methods and analysisThis is a single-centre, dual arm randomised controlled trial. Patients requiring abdominal wall reconstruction will be assessed for eligibility. Eligible patients will then undergo an informed consent process following by randomisation to either (1) crosslinked porcine dermis mesh (Permacol); or (2) non-crosslinked porcine dermis mesh (Strattice). These groups will be compared for the rate of hernia recurrence at 1 and 2 years as well as the rate of postoperative complications (eg, surgical site infections).Ethics and disseminationThis study has been approved by the institution’s research ethics board and registered with clinicaltrials.gov. All eligible participants will provide informed consent prior to randomization. The results of this study may help guide the choice of biologic mesh for this population. The results of this study will be published in peer-reviewed journals as well as national and international conferences.Trial registration numberNCT02703662.

Purpose Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu ® without drainage is equal/ non-inferior to standard mastecomy with drainage. Methods The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu ® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups. Results Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu ® group than in the drainage group, especially aspirations of clinically relevant seromas ( p  = 0.014). The TissuGlu ® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu ® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu ® compared to standard drainage couldn’t be reached. Discussion The present evaluation shows no advantage of the tissue adhesive TissuGlu ® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures. We did a cohort study of women in Scotland aged 20 years or older undergoing a first, single incontinence procedure or prolapse procedure during 1997–98 to 2015–16 identified from a national hospital admission database. Primary outcomes were immediate postoperative complications and subsequent (within 5 years) readmissions for later postoperative complications, further incontinence surgery, or further prolapse surgery. Poisson regression models were used to compare outcomes after procedures carried out with and without mesh. Between April 1, 1997, and March 31, 2016, 16 660 women underwent a first, single incontinence procedure, 13 133 (79%) of which used mesh. Compared with non-mesh open surgery (colposuspension), mesh procedures had a lower risk of immediate complications (adjusted relative risk [aRR] 0·44 [95% CI 0·36–0·55]) and subsequent prolapse surgery (adjusted incidence rate ratio [aIRR] 0·30 [0·24–0·39]), and a similar risk of further incontinence surgery (0·90 [0·73–1·11]) and later complications (1·12 [0·98–1·27]); all ratios are for retropubic mesh. During the same time period, 18 986 women underwent a first, single prolapse procedure, 1279 (7%) of which used mesh. Compared with non-mesh repair, mesh repair of anterior compartment prolapse was associated with a similar risk of immediate complications (aRR 0·93 [95% CI 0·49–1·79]); an increased risk of further incontinence (aIRR 3·20 [2·06–4·96]) and prolapse surgery (1·69 [1·29–2·20]); and a substantially increased risk of later complications (3·15 [2·46–4·04]). Compared with non-mesh repair, mesh repair of posterior compartment prolapse was associated with a similarly increased risk of repeat prolapse surgery and later complications. No difference in any outcome was observed between vaginal and, separately, abdominal mesh repair of vaginal vault prolapse compared with vaginal non-mesh repair. Our results support the use of mesh procedures for incontinence, although further research on longer term outcomes would be beneficial. Mesh procedures for anterior and posterior compartment prolapse cannot be recommended for primary prolapse repair. Both vaginal and abdominal mesh procedures for vaginal vault prolapse repair are associated with similar effectiveness and complication rates to non-mesh vaginal repair. These results therefore do not clearly favour any particular vault repair procedure. None.

Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0–100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7·2 points (95% CI 5·7–8·8), from 26·0 at baseline to 33·4 at 1 month, in the kyphoplasty group, and by 2·0 points (0·4–3·6), from 25·5 to 27·4, in the non-surgical group (difference between groups 5·2 points, 2·9–7·4; p<0·0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. Our findings suggest that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option. Medtronic Spine LLC.

Background This meta-analysis aimed to determine the bone union rate of bone defects treated with the different autologous bone graft techniques. Methods The PubMed and the Cochrane Library databases were searched using the terms: ‘fracture’ AND (‘bone loss’ OR ‘defect’ OR ‘defects’) AND ‘bone graft’, restricted to English language, to human species, and to a publication period from January 1999 to November 2014. Data were extracted by one of the reviewers and then checked by the second. A quality of evidence score and a methodology score were used. Heterogeneity was assessed. A random effects model approach was used to combine estimates. Results Out of 376 selected studies only 34 met the inclusion criteria. The summary pooled union rate was 91 % (95 % CI: 87–95 %) while union rate after additional procedures raised to 98 % (95 % CI 96–99 %). No association between union rate and bone defect size was found. (Univariable regression model: vascularized: P  = 0.677; non-vascularized: 0.202. Multivariable regression model: vascularized: P  = 0.381; non-vascularized: P  = 0.226). Vascularized graft was associated with a lower risk of infection after surgery when compared to non-vascularized graft (95 % CI 0.03 to 0.23, p  < 0.001). Conclusion The results of this meta-analysis demonstrate the effectiveness of autologous graft for bone defects. Furthermore, from the available clinical evidence bone defect size does not seem to have an impact on bone union when treated with autologous bone graft techniques.

Abstract BACKGROUND Cranioplasty is a ubiquitous neurosurgical procedure consisting of reconstruction of a pre-existing calvarial defect. Many materials are available, including polymethylmethacrylate in hand-moulded (hPMMA) and prefabricated (pPMMA) form, hydroxyapatite (HA), polyetheretherketone (PEEK) and titanium (Ti). OBJECTIVE To perform a network meta-analysis (NMA) to assess the relationship between materials and complications of cranioplasty. METHODS PubMed/MEDLINE, Google Scholar, EMBASE, Scopus, and The Cochrane Library were searched from January 1, 1990 to February 14, 2021. Studies detailing rates of any of infections, implant exposure, or revision surgery were included. A frequentist NMA was performed for each complication. Risk ratios (RRs) with 95% CIs were calculated for each material pair. RESULTS A total of 3620 abstracts were screened and 31 full papers were included. Surgical revision was reported in 18 studies and occurred in 316/2032 cases (14%; 95% CI 11-17). PEEK had the lowest risk of re-operation with a rate of 8/157 (5%; 95% CI 0-11) in 5 studies, superior to autografts (RR 0.20; 95% CI 0.07-0.57), hPMMA (RR 0.20; 95% CI 0.07-0.60), Ti (RR 0.39; 95% CI 0.17-0.92), and pPMMA (RR 0.14; 95% CI 0.04-0.51). Revision rate was 131/684 (19%; 95% CI 13-25; 10 studies) in autografts, 61/317 (18%; 95%CI 9-28; 7 studies) in hPMMA, 84/599 (13%; 95% CI 7-19; 11 studies) in Ti, 7/59 (9%; 95% CI 1-23; 3 studies) in pPMMA, and 25/216 (12%; 95% CI 4-24; 4 studies) in HA. Infection occurred in 463/4667 (8%; 95% CI 6-11) and implant exposure in 120/1651 (6%; 95% CI 4-9). CONCLUSION PEEK appears to have the lowest risk of cranioplasty revision, but further research is required to determine the optimal material. Graphical Abstract Graphical Abstract