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.     

Accuracy evaluation of image registration and segmentation tools used in conformal treatment planning of prostate cancer.

Segmentation and registration tools are commonly used in radiotherapy for target and at risk organs localisation. In this work the performances of three different segmentation tools and of a surface matching registration technique, used on computed tomography (CT) and magnetic resonance (MR) images for the treatment planning of conformal prostate carcinoma, are studied. The accuracy of the segmentation and registration tools was evaluated by phantom experiment and on patient data, respectively. A preliminary estimate of MR image distortion was also performed.     

Control of post anaesthetic shivering with nefopam hydrochloride in mildly hypothermic patients after neurosurgery

Postoperative shivering may be prevented by maintaining normothermia intraoperatively or it may be treated using specific drugs. The aim of this study was to compare the efficacy of nefopam hydrochloride (nefopam) to that of clonidine and meperidine in patients undergoing elective neurosurgical procedures. Three groups of patients were included in the study. Patients in group A (60) received i.v., at random, 20 mg of nefopam, 50 mg of meperidine or 150 μg of clonidine in the immediate postoperative period. The incidence of shivering and the time at which shivering ceased were noted, along with central temperature and main haemodynamic changes. Group B (20) received i.v., at random, either 10 mg of nefopam or saline before awakening from anaesthesia. The effects of nefopam on central temperature, oxygen consumption (Vo₂), carbon dioxide production (VcO₂), basal metabolic rate (BMR) and energy expenditure (EE) were investigated. Group C (10) received i.v. 20 mg of nefopam during surgery: cerebrospinal fluid pressure (CSFP), cerebral perfusion pressure (CPP) and electroencephalogram (EEG) were monitored. In group A nefopam stopped shivering in 95% of patients when compared to meperidine and clonidine, which were effective in 32% and 40% of patients respectively. In group B, only 10% of patients receiving nefopam had postoperative shivering, Vo2, VcO2 and EE were significantly lower in patients treated with nefopam than those in the control group. No changes in CSFP, CPP or EEG were observed in group C. In conclusion, nefopam seems to be more effective than clonidine or meperidine in quickly suppressing shivering, without producing significant adverse reactions.