A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal™): report of a three-center phase II clinical trial

Objective: To investigate on the feasibility, safety, and effectiveness of a new bioabsorbable material for lung staple-line reinforcement. Methods: This prospective open trial included 66 patients (mean age of 56 ± 17 years) who underwent various types of lung resection using staplers with knitted calcium alginate sleeves for buttressing (FOREseal™, Laboratoires Brothier, Nanterre, France) at three academic centers: 29 lobectomies, 22 emphysema surgeries, 15 wedge resections or lung biopsies. Intraoperative air leakage was assessed at a mean respiratory peak pressure of 30 cmH₂O, and rated as grade 1, 2, or 3. Persistent air leakage in the postoperative course, as well as any relevant event, was assessed daily. The follow-up period was of 6 months. Results: No technical problem linked to the device occurred. Hemostasis of the cutting edges was completed in all patients. Fifty-six percent of the patients had no intraoperative air leak and 27.3% had grade 1 leaks. Mean postoperative air leaks and thoracic drainage times were 1.9 ± 2.3 days and 6 ± 5.3 days, respectively. In-hospital mortality was nil. There was no empyema. Mean hospital stay was 9.1 ± 6.6 days. At follow-up, one patient underwent lung transplantation, and pathology of the explanted specimen showed the absence of device-related foreign-body inflammation. One patient complained from metalloptysis, and another one, with a metastatic invasive aspergillosis, developed an infectious recurrence that required reoperation. Conclusions: FOREseal is an ergonomic, safe, and promising new material instead of nonabsorbable materials and xenomaterials for staple-line reinforcement. A randomized comparative study is now in progress.     

Is levator hiatus distension associated with peripheral ligamentous laxity during pregnancy?

Introduction and hypothesis

The impact of pregnancy on pelvic floor disorders remains poorly understood. During pregnancy, an increase in ligamentous laxity and pelvic organ mobility is often reported. Our main objective was to investigate a possible association between peripheral ligamentous laxity and levator hiatus (LH) distension during pregnancy.

Methods

This was a prospective longitudinal study of 26 pregnant women followed up from the first to the third trimester. We collected the following information: occurrence of pelvic organ prolapse (POP) symptoms (score higher than 0 for the POP section of the Pelvic Floor Distress Inventory 20 questions score), 4D perineal ultrasound scan results with LH distension assessment and measurement of metacarpophalangeal joint mobility (MCP laxity). The association between MCP laxity and LH distension was estimated by mixed multilevel linear regression. The associations between MCP laxity and categorical parameters were estimated in a multivariate analysis using a generalized estimating equation model.

Results

MCP laxity and LH distension were correlated with a correlation coefficient of 0.26 (p?=?0.02), and 6.8% of the LH distension variance was explained by MCP laxity. In the multivariate analysis, MCP laxity was associated with POP symptoms with an odds ratio at 1.05 (95% CI 1.01–1.11) for an increase of 1° in MCP laxity.

Conclusion

LH distension and peripheral ligamentous laxity are significantly associated during pregnancy. However, the relationship is weak, and the results need to be confirmed in larger populations and with more specific techniques such as elastography to directly assess the elastic properties of the pelvic floor muscles.

     

Clonidine as an adjuvant to intrathecal local anesthetics for surgery: systematic review of randomized trials

BACKGROUND AND OBJECTIVES: Clonidine is added to intrathecal local anesthetics to improve intraoperative analgesia and to increase the duration of sensory and motor block. The aim of this systematic review is to quantify beneficial and harmful effects of clonidine when used as an adjuvant to intrathecal local anesthetics for surgery. METHODS: We included data from 22 randomized trials (1,445 patients) testing a large variety of doses of clonidine, added to intrathecal bupivacaine, mepivacaine, prilocaine, or tetracaine. RESULTS: Clonidine 15 to 150 microg prolonged in a linear, dose-dependent manner, the time to 2 segment regression (range of means, 14 to 75 minutes) and the time to regression to L2 (range of means, 11 to 128 minutes). The time to first analgesic request (median 101 minutes, range 35 to 310) and of motor block (median 47 minutes, range 6 to 131) was prolonged without evidence of dose-responsiveness. Time to achieve complete sensory or motor block, and extent of cephalic spread remained unchanged. There were fewer episodes of intraoperative pain with clonidine (relative risk, 0.24; 95% confidence interval [CI], 0.09-0.64; number needed to treat, 13) but more episodes of arterial hypotension (relative risk, 1.81; 95% CI 1.44-2.28; number needed to harm, 8) without evidence of dose-responsiveness. The risk of bradycardia was unchanged. CONCLUSIONS: This study may serve as a rational basis to help clinicians decide whether or not to combine clonidine with an intrathecal local anesthetic for surgery. The optimal dose of clonidine, however, remains unknown.     

A 16-year clinical experience with intermittent androgen deprivation for prostate cancer: oncological results

Objective  

To present oncological results with intermittent androgen deprivation (IAD) in a single center.     

IGL-1 solution in kidney transplantation: first multi-center study

Abstract:  IGL-1 solution is characterized by inversion of K+ and Na+ concentrations in the University Wisconsin (UW) solution and polyethylene glycol 35 (PEG 35) substitution for hydroxy ethyl starch. In this prospective study, 121 patients transplanted with kidneys preserved in IGL-1 solution were compared to 102 patients grafted with kidneys preserved in UW solution. Serum creatinine and creatinine clearance, delayed graft function (DGF) and rejection episodes, patient and graft survival were evaluated in the first post-transplant year. Groups were comparable regarding to donor and recipient characteristics. Median creatinine levels were significantly lower in IGL-1 group from day 6 to day 14 and it decreased more rapidly in the IGL-1 group (from day 4 to day 15: p < 0.05). Creatinine clearance values were usually higher in the IGL-1 group for the first 15 d. During the follow-up period serum creatinine concentrations were lower in IGL-1 group at one, three, six and 12 months after transplantation (p = 0.04; p = 0.06, p = 0.01 and p = 0.08, respectively) while creatinine clearance values were similar during the follow-up. No significant difference in DGF and rejection rates as well as in patient and graft survival was shown between the two groups. Kidneys preserved in IGL-1 solution showed to have the same function as kidneys preserved in UW solution.     

Patient-based decision for resuming activity after ACL reconstruction: a single-centre experience

Purpose

The purpose of the study was to report the functional outcome following anterior cruciate ligament (ACL) reconstruction in patients who decide when to resume work and normal sporting activity post-operatively. The hypothesis tested was that patient-based decision to return to work and sport was possible without compromising functional outcome and increased the rate of repeat rupture in comparison with the existing literature.

Methods

This was a monocentric, retrospective study. Seventy-two patients requiring primary ACL reconstruction were included. All patients were followed up for a mean period of 4.3 years. Return to work and to sporting activity was allowed based on patient’s decision. No restriction was suggested by the physician. Delays to return to work and sports and occurrence of graft failure were documented.

Results

Sixty-six patients (92 %) returned to any sporting activity. The mean delay was 4.1 months for running, 6.1 months for pivoting sports, and 6.6 months for contact sports. Return to competitive sport was possible in 82 % of patients after a mean delay of 7.1 months. Return to work was possible for 96 % of patients after a mean delay of 2.3 months. Index Tegner score normalized in 71 % of patients. Four repeat ruptures (6 %) were observed, all of them following a significant knee injury.

Conclusions

Patient-based decision to return to work and sport was possible without compromising functional outcome. The post-operative restrictions implemented by orthopaedic surgeons following ACL reconstructions may be relaxed and more patient based.

     

Laser phototherapy improves early stage of cutaneous wound healing of rats under hyperlipidic diet

The aim of this study was to evaluate the influence of laser photobiomodulation in cutaneous healing of rats under a hyperlipidic diet. Forty-eight Wistar Albinus rats, weaned, received standard diet (SD) or hyperlipidic diet (HD) for 20 weeks. The groups were divided into SD rats and HD rats, SD-irradiated rats (LSD), and HD-irradiated rats (LHD). Standard cutaneous wound (1 cm²) was created on the dorsum of each rat. The irradiation started immediately after surgery and every 48 h for 7 or 14 days (λ660 nm, 40 mW, 6 J/cm², ? 0,04 cm², CW), when they were killed under deep anesthesia. The specimens were removed, routinely processed, stained with hematoxylin/eosin (H/E), and evaluated by light microscopy. Rats fed with hyperlipidic diet had greater intensity in the inflammatory process and prolonged hyperemia. At day 7, the intensity of inflammation was reduced in LSD and LHD groups when compared to their control groups, SD (p?=?0.002) and HD (p?=?0.02). There was an increase in fibroblast proliferation and collagen deposition, especially in the LHD group. At day 14, the HD group presented more intensive hyperemia than the SD group. It can be concluded that the hyperlipidic diet modified the inflammation pattern in wound healing and that laser light has a positive biomodulative effect on the healing process only in early stages.