Complications of laparoscopy: an inquiry about closed- versus open-entry technique

OBJECTIVE: The purpose of this study was to determine the amount of complications and the incidence of open- versus closed-entry (either by Veress needle or first trocar) technique in gynecologic laparoscopy in The Netherlands. STUDY DESIGN: Questionnaire analysis of members of the Dutch Society for Gynaecological Endoscopy and Minimal Invasive Surgery was combined with a Medline literature search. Data related to complications on entry from January 1,1997, through December 31, 2001, were collected by questionnaire and were separated into group I (Veress needle or first trocar) and group II (open-entry technique). The number of laparoscopy procedures, years of experience, and indications to perform the chosen entry technique were collected. RESULTS: Response rate was 98%. The procedures were performed by 187 gynecologists in 74 hospitals (72%) in The Netherlands. Groups I and II were comparable to each other, with respect to type of clinic (teaching vs nonteaching hospital), the number of procedures, and the experience of gynecologists. One hundred six gynecologists (57%) used only the closed-entry technique. This group reported 31 complications (0.1%) in 31,532 procedures. Even in the case of patients who were at risk for entry-related complications (previous laparotomy, obesity), pneumoperitoneum was established by the closed-entry technique. However, most gynecologists used an alternative insufflation point (eg, Palmer's point). The remaining 81 gynecologists used both entry techniques. However, the open-entry technique was used on special indications and in only 2.0% of cases (range: 1-20%). These special indications were suspected adhesions or previous laparotomy (90%) and obese (7%) or very thin patients (3%). These 81 gynecologists reported 20,027 closed-entry procedures and 579 open-entry procedures and complication rates of 0.12% and 1.38%, respectively (P<.001). Significantly more visceral lesions were found (P<.001) at open-entry technique in group II. Our literature search showed a calculated average entry complication rate for the closed-entry technique for visceral and vascular lesions of 0.44 of 1000 procedures and 0.31 of 1000 procedures, respectively. CONCLUSION: Although 43% of the gynecologists in this study performed the open-entry technique in laparoscopy, Dutch gynecologists seldom use this technique. When it is performed in selected patients, the number of complications is not reduced necessarily. In contrast to published data of general surgeons' findings, the number of entry-related complications in the open technique was significantly higher than the closed-entry technique. There is no evidence to abandon the closed-entry technique in laparoscopy. However, the selection of patients for an open- or alternative-entry procedure is still recommended.     

Nonalbuminuric renal insufficiency in type 2 diabetes

OBJECTIVE: To determine the prevalence and characteristics of patients with type 2 diabetes who have impaired renal function, defined as a glomerular filtration rate (GFR) <60 ml. min(-1). 1.73 m(-2), and normoalbuminuria. RESEARCH DESIGN AND METHODS: A cross-sectional survey of 301 outpatients attending a single tertiary referral center using the plasma disappearance of isotopic (99m)Tc-diethylene-triamine-penta-acetic acid to measure GFR and at least two measurements of urinary albumin excretion rate (AER) over 24 h to determine albuminuria. RESULTS: A total of 109 patients (36%) had a GFR <60 ml. min(-1). 1.73 m(-2). The overall prevalence of normo-, micro-, and macroalbuminuria was 43 of 109 (39%), 38 of 109 (35%), and 28 of 109 (26%), respectively. Compared with patients with macroalbuminuria, those with normoalbuminuria were more likely to be older and female. After excluding patients whose normoalbuminuric status was possibly related to the initiation of a renin-angiotensin system (RAS) inhibitor before the start of the study, the prevalence of a GFR <60 ml. min(-1). 1.73 m(-2) and normoalbuminuria was 23%. Temporal changes in GFR in a subset of 34 of 109 (32%) unselected patients with impaired renal function were available for comparison over a 3- to 10-year period. The rates of decline in GFR (ml. min(-1). 1.73 m(-2). year(-1)) of -4.6 +/- 1.0, -2.8 +/- 1.0, and -3.0 +/- 07 were not significantly different for normo- (n = 12), micro- (n = 12), and macroalbuminuric (n = 10) patients, respectively. CONCLUSIONS: These results suggest that patients with type 2 diabetes can commonly progress to a significant degree of renal impairment while remaining normoalbuminuric.     

Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Heart Disease in Postmenopausal Women

Context.— Observational studies have found lower rates of coronary heart disease (CHD) in postmenopausal women who take estrogen than in women who do not, but this potential benefit has not been confirmed in clinical trials. Objective.— To determine if estrogen plus progestin therapy alters the risk for CHD events in postmenopausal women with established coronary disease. Design.— Randomized, blinded, placebo-controlled secondary prevention trial. Setting.— Outpatient and community settings at 20 US clinical centers. Participants.— A total of 2763 women with coronary disease, younger than 80 years, and postmenopausal with an intact uterus. Mean age was 66.7 years. Intervention.— Either 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate in 1 tablet daily (n=1380) or a placebo of identical appearance (n=1383). Follow-up averaged 4.1 years; 82% of those assigned to hormone treatment were taking it at the end of 1 year, and 75% at the end of 3 years. Main Outcome Measures.— The primary outcome was the occurrence of nonfatal myocardial infarction (MI) or CHD death. Secondary cardiovascular outcomes included coronary revascularization, unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke or transient ischemic attack, and peripheral arterial disease. All-cause mortality was also considered. Results.— Overall, there were no significant differences between groups in the primary outcome or in any of the secondary cardiovascular outcomes: 172 women in the hormone group and 176 women in the placebo group had MI or CHD death (relative hazard [RH], 0.99; 95% confidence interval [CI], 0.80-1.22). The lack of an overall effect occurred despite a net 11% lower low-density lipoprotein cholesterol level and 10% higher high-density lipoprotein cholesterol level in the hormone group compared with the placebo group (each P<.001). Within the overall null effect, there was a statistically significant time trend, with more CHD events in the hormone group than in the placebo group in year 1 and fewer in years 4 and 5. More women in the hormone group than in the placebo group experienced venous thromboembolic events (34 vs 12; RH, 2.89; 95% CI, 1.50-5.58) and gallbladder disease (84 vs 62; RH, 1.38; 95% CI, 1.00-1.92). There were no significant differences in several other end points for which power was limited, including fracture, cancer, and total mortality (131 vs 123 deaths; RH, 1.08; 95% CI, 0.84-1.38). Conclusions.— During an average follow-up of 4.1 years, treatment with oral conjugated equine estrogen plus medroxyprogesterone acetate did not reduce the overall rate of CHD events in postmenopausal women with established coronary disease. The treatment did increase the rate of thromboembolic events and gallbladder disease. Based on the finding of no overall cardiovascular benefit and a pattern of early increase in risk of CHD events, we do not recommend starting this treatment for the purpose of secondary prevention of CHD. However, given the favorable pattern of CHD events after several years of therapy, it could be appropriate for women already receiving this treatment to continue.