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1.
Surg Endosc ; 19(8): 1125-9, 2005 Aug.
Article in English | MEDLINE | ID: mdl-16021367

ABSTRACT

BACKGROUND: This prospective study of a new titanium-coated low-weight polypropylene (PP) mesh (16 g PP/m2) was designed to investigate the clinical efficacy and safety of totally extraperitoneal endoscopic hernioplasty (TEP). METHODS: In this study, 400 patients (average age, 53.5 years; range, 19-80 years) with a total of 588 inguinal hernias underwent surgery with the TEP technique between September 2002 and October 2003. Of these patients, 12.4% had experienced recurrent hernias after open suture herniotomy. In 92% of the cases (368 patients with 540 hernias), a lightweight (16 g PP/m2) titanium-coated polypropylene mesh was implanted without fixation, and in 8% (32 patients with 48 hernias) an identical medium-weight (35 g PP/m2) mesh was implanted. The first follow-up examination was scheduled for postoperative week 6. RESULTS: In the lightweight mesh group, the mean group, operating time per patient was 61 min, corresponding to a calculated time per hernia of 41 min. Two intraoperative major complications occurred: an injury to the cecum and an injury to the bladder. In 12 cases (2%), bleeding from epigastric, testicular, or pubic bone vessels was observed. No injuries to pelvic vessels were seen. One patient was underwent an endoscopic revision to deal with an anticoagulation-related bleed. The mortality rate was 0%. In 12 patients, postoperative hematomas developed. One preperitoneal lipoma had to be extirpated. No infections of the mesh occurred. The median follow-up period for 371 patients (92.3%) was 7.2 weeks (range, 4-14 weeks). These 343 patients (with 504 hernias) had been provided with a lightweight titanium-coated polypropylene mesh (16 g PP/m2) (follow-up rate, 93.2%). Of these patients, 3.5% reported persistent ingunial pain, 1.7% described a sensation of rigidity in the region of the groin, and 3.2% reported dysesthesia. The early recurrence rate was 0.2%. CONCLUSIONS: The TEP procedure can be performed safely and effectively with the appreciably material-reduced and titanium-coated polypropylene mesh without the need for fixation of the implant. The low early recurrence rate of 0.2% is evidence that the posterior wall of the inguinal canal is adequately augmented. The question whether the material reduction and the titanium coating of the mesh may bring about a reduction in postoperative chronic pain and the sensation of rigidity in the inguinal area via an improvement in biocompatibility must await the results of the scheduled follow-up examination 1 year after the surgical procedure.


Subject(s)
Hernia, Inguinal/surgery , Polypropylenes , Surgical Mesh , Titanium , Adult , Aged , Aged, 80 and over , Equipment Design , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Prospective Studies
2.
BMJ ; 317(7155): 379-84, 1998 Aug 08.
Article in English | MEDLINE | ID: mdl-9694753

ABSTRACT

OBJECTIVE: To compare the feasibility of treatment, safety, and toxicity of intravenous amphotericin B deoxycholate prepared in either glucose or intralipid for empirical antimycotic treatment of neutropenic cancer patients. DESIGN: Single centre stratified, randomised non-blinded phase II study. SETTING: University hospital providing tertiary clinical care. SUBJECTS: 51 neutropenic patients (leukaemia (35), lymphoma (11), solid tumours (5)) with refractory fever of unknown origin (24) or pneumonia (27). INTERVENTIONS: Amphotericin B 0.75 mg/kg/day in 250 ml glucose 5% solution or mixed with 250 ml intralipid 20%, given on eight consecutive days then alternate days, as a 1-4 hour infusion. MAIN OUTCOME MEASURES: Feasibility of treatment, subjective tolerance (questionnaire), and objective toxicity (common toxicity criteria of the National Cancer Institute). RESULTS: Study arms were balanced for age, sex, underlying malignancy, renal and liver function, and pre- and concomitant treatment with antibiotics and nephrotoxic agents. No statistically significant or clinically relevant differences were found between the treatment groups for: daily or cumulative dose and duration of treatment with amphotericin B; incidence and time of dose modifications or infusion duration changes related to toxicity; dose or duration of symptomatic support with opiates, antipyretics, or antihistamines; renal function; subjective tolerance; most common toxicity scores; course of infection; and incidence of treatment failures. Patients treated with amphotericin B in intralipid were given fewer diuretics (P<0.05) and therefore had more peripheral oedema (P<0.01) and needed less potassium supplementation (P<0.05) than patients given amphotericin in glucose. Acute respiratory events were more common in the intralipid arm (P<0.05). CONCLUSIONS: Amphotericin B 0.75 mg/kg/day in intralipid given on eight consecutive days then alternate days provides no benefit and is associated with potential pulmonary side effects possibly because of fat overload or an incompatibility of the two drugs.


Subject(s)
Amphotericin B/adverse effects , Antifungal Agents/adverse effects , Fever of Unknown Origin/drug therapy , Neutropenia/complications , Pneumonia/drug therapy , Adolescent , Adult , Aged , Amphotericin B/administration & dosage , Amphotericin B/chemistry , Antifungal Agents/administration & dosage , Antifungal Agents/chemistry , Drug Carriers , Drug Compounding , Fat Emulsions, Intravenous/administration & dosage , Feasibility Studies , Female , Fever of Unknown Origin/complications , Glucose/administration & dosage , Humans , Infusions, Intravenous , Male , Middle Aged , Pneumonia/complications , Prospective Studies
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