Biomedical subjects

J Hermans

Publications and source records attributed to J Hermans.

At least 145 records · Page 8Linked to original sources

PubMed1997

Central nervous system relapse in non-Hodgkin lymphoma. A single-center study of 532 patients.

OBJECTIVES: To define the cumulative risk of central nervous system (CNS) relapse in systemic non-Hodgkin lymphoma (NHL); to assess the risk factors of age, sex, malignancy grade, stage, localization, and response to initial therapy; and to evaluate the effect of CNS prophylaxis. PATIENTS AND METHODS: An unselected group of 532 patients with systemic NHL. A retrospective analysis. RESULTS: Eleven patients presented with systemic as well as CNS localization, whereas in 55 patients, CNS relapse occurred later. The cumulative risk of CNS relapse at 4 years for all 532 patients was 19%. High-grade NHL carried a 39% risk of CNS relapse, with the vast majority of relapses occurring in the first 14 months after the initial diagnosis. The cumulative risk in patients with intermediate-grade NHL was considerable (22%) and dispersed throughout a much longer period (6 years). Patients with low-grade NHL still carried a 7% risk of CNS relapse; in all these patients, low malignancy grade was transformed into a higher malignancy grade at that time. In a multivariate analysis, high- and intermediate-grade NHL and advanced stage were independent risk factors for CNS relapse. There was not any strong evidence for a beneficial role of CNS prophylaxis in patients with intermediate- and high-grade NHL, but a retrospective analysis cannot be conclusive with regard to the effect of therapy. Systemic relapse occurred rapidly after CNS relapse, resulting in a median survival time after CNS relapse of only 2 months. CONCLUSIONS: Patients with high- and intermediate-grade NHL carry a considerable risk of CNS relapse. Advanced stage is an additional independent risk factor. The role of CNS prophylaxis seems to be disappointing, but a retrospective analysis cannot be conclusive. Prognosis after CNS relapse is poor.

Adolescent↗

PubMed1997

Early cognitive and motor symptoms in identified carriers of the gene for Huntington disease.

OBJECTIVE: To study early motor and cognitive symptoms in Huntington disease. DESIGN: A follow-up cohort study after a DNA test procedure in which gene carriers and noncarriers were identified among people genetically at risk for Huntington disease. SETTING: Leiden University Medical Center, Department of Neurology, Leiden, the Netherlands, in cooperation with the Clinical Genetics Center Leiden and the Department of Medical Psychology and Psychotherapy, Erasmus University Rotterdam, Rotterdam, the Netherlands. PARTICIPANTS: Thirty-three individuals: 9 unaffected gene carriers, 6 gene carriers with motor symptoms, and 18 noncarriers of the gene for Huntington disease. MAIN OUTCOME MEASURES: A neuropsychologic examination covering a broad area of cognitive functioning, reaction time procedures, and motor tasks. RESULTS: The neuropsychologic assessment showed no significant differences between presymptomatic gene carriers and noncarriers. Three motor tasks differentiated between these 2 groups on a liberal .05 P level (analysis of variance followed by the Student test). The affected gene carriers performed less well than the presymptomatic gene carriers and the noncarriers in 10 motor tasks and 7 cognitive tasks. These differences were significant at P < .05. CONCLUSION: Motor symptoms play a more prominent and unequivocal role than cognitive symptoms in early stages of Huntington disease.

Adult↗

PubMed1997

Markers for assessment of nodal metastasis in laryngeal carcinoma.

BACKGROUND: Regional metastasis is an important factor in the treatment and prognosis of patients with head and neck squamous cell carcinoma. Although in recent years imaging techniques have improved, it is still impossible to detect small metastatic deposits. Metastasis is mainly determined by properties of the primary tumor and its interaction with surrounding structures. OBJECTIVE: To identify markers that predict the presence of metastasis based on the features of the primary tumor. DESIGN: Correlation of the results of histological, immunohistochemical, and molecular biological analysis with clinical and histopathological data. MATERIALS AND METHODS: Several histological features and biological markers were examined in 31 laryngeal carcinomas. The following markers were selected on their putative role in the process of metastasis and were studied using immunohistochemical and/or Southern blot techniques: proliferating cell nuclear antigen (PCNA), p53, retinoblastoma tumor-suppressor gene (Rb), myc, bcl-2 (inhibitor of apoptosis), epidermal growth factor (EGF), EGF-receptor (EGFR), neu, nm23 (also known as NME1, putative metastasis suppressor), desmoplakin, neuron cell-adhesion molecule (N-CAM), epithelial cell-adhesion molecule (Ep-CAM), E-cadherin, cyclin D1 (CCND1), and EMS1. RESULTS: The presence of an inflammatory reaction surrounding the tumor (P = .07), eosinophilic infiltration (P = .16), positive immunostaining for Rb (P = .02), negative immunostaining for Ep-CAM (P = .13), and amplification of CCND1 and EMS1 (P = .05) correlated with nodal metastasis. The combination of an inflammatory reaction, eosinophilic infiltration, and staining for Rb and Ep-CAM resulted in a superior accuracy in assessing nodal metastasis. CONCLUSIONS: These results indicate that it is possible to predict and exclude lymph node metastasis by studying the features of the primary tumor only. When these results are confirmed in a larger series, biological markers may be powerful diagnostic tools with great impact on clinical decision making.

Antibodies, Monoclonal↗

PubMed1997

Expression of p53 in adrenocortical tumours: clinicopathological correlations.

There are limited data to suggest that abnormalities of p53 expression may be a late event in the development of adrenocortical tumours. This has been investigated further by examining a series of adrenocortical adenomas and carcinomas by immunohistochemistry for p53 expression and a subset for evidence of mutation in exons 5-8 of the p53 gene using polymerase chain reaction/single strand conformational polymorphism (PCR/SSCP). In carcinomas, the findings have been correlated with survival data and with tumour ploidy. Immunopositivity for p53 was seen in 4 of 34 adenomas and 22 of 42 carcinomas. Mobility shifts were identified in 1 of 4 adenomas and 10 of 21 carcinomas. There was no correlation between immunostaining pattern or PCR/SSCP evidence of mutation and either survival or disease-free survival in carcinoma. There was also no correlation between p53 status and tumour ploidy. While these findings support a role for p53 in tumour progression, abnormal p53 expression does not appear to have any significant prognostic effect in carcinoma.

Adrenal Cortex Neoplasms↗

PubMed1997

Human papillomavirus infection in squamous cell carcinoma of the vulva, in various synchronous epithelial changes and in normal vulvar skin.

OBJECTIVE: To investigate the prevalence of human papillomavirus (HPV) infection in various vulvar lesions. METHODS: HPV infection using consensus primer-PCR was studied in 66 patients with vulvar carcinoma and in the synchronous epithelial lesions. RESULTS: HPV infection was present in 13/66 carcinoma, in 1/33 VIN I, in 3/11 VIN II, in 8/16 VIN III, in 2/30 lichen sclerosus, in 1/37 squamous cell hyperplasia, and in 2/55 normal skin specimens. Normal skin from healthy controls showed HPV-negative specimens only. Patients with HPV-positive carcinomas were younger, presented in lower stages, and had high-grade VIN more often than those with HPV-negative carcinomas. CONCLUSIONS: In sum we found that all types of epithelial changes synchronous with carcinoma of the vulva showed HPV infection, indicating that they all might have malignant potential.

Adult↗

PubMed1997

SIMS: computation of a smooth invariant molecular surface.

SIMS, a new method of calculating a smooth invariant molecular dot surface, is presented. The SIMS method generates the smooth molecular surface by rolling two probe spheres. A solvent probe sphere is rolled over the molecule and produces a Richards-Connolly molecular surface (MS), which envelops the solvent-excluded volume of the molecule. In deep crevices, Connolly's method of calculating the MS has two deficiencies. First, it produces self-intersecting parts of the molecular surface, which must be removed to obtain the correct MS. Second, the correct MS is not smooth, i.e., the direction of the normal vector of the MS is not continuous, and some points of the MS are singular. We present an exact method for removing self-intersecting parts and smoothing the singular regions of the MS. The singular MS is smoothed by rolling a smoothing probe sphere over the inward side of the singular MS. The MS in the vicinity of singularities is replaced with the reentrant surface of the smoothing probe sphere. The smoothing method does not disturb the topology of a singular MS, and the smooth MS is a better approximation of the dielectric border between high dielectric solvent and the low dielectric molecular interior. The SIMS method generates a smooth molecular dot surface, which has a quasi-uniform dot distribution in two orthogonal directions on the molecular surface, which is invariant with molecular rotation and stable under changes in the molecular conformation, and which can be used in a variety of implicit methods of modeling solvent effects. The SIMS program is faster than the Connolly MS program, and in a matter of seconds generates a smooth dot MS of a 200-residue protein. The program is available from the authors on request (see http:@femto.med.unc.edu/SIMS).

Algorithms↗

PubMed1997

Hypofractionated radiotherapy for invasive bladder cancer.

BACKGROUND AND PURPOSE: The policy of the Radiotherapy Department of St. Thomas' Hospital in London for patients with invasive bladder cancer, used to be treatment with hypofractionated radiotherapy. The advantages of this fractionation scheme included reduction of the number of treatment sessions and better use of limited resources. Our results after hypofractionation were compared to series with more conventional radiotherapy. MATERIAL AND METHODS: Between 1975 and 1985, 123 patients with a T2-T3 transitional cell carcinoma of the bladder were treated by a radical course of hypofractionated radiotherapy. Local control, survival and morbidity rates were analysed retrospectively. RESULTS: The actuarial local control rates at 5 and 10 years were 31 and 29%, respectively. The actuarial cancer-specific 5- and 10-year survival rates were 48 and 39%, respectively. Acute side effects were observed in 87% of patients. The actuarial overall and severe late complication rates at 5 years were 33 and 9%, respectively. The local control, survival and early side effect rates we found, were in the same range as those reported in literature. Late radiation side effects however, were more common after hypofractionated radiotherapy compared to conventional radiotherapy schedules. CONCLUSIONS: We conclude that the potential advantage of a reduced number of treatment sessions may be lost in the long term, because of the higher incidence of late morbidity after hypofractionated radiotherapy. Hypofractionation however, remains a valuable technique for palliation and deserves further investigation for radical treatment where access to equipment is difficult or resources are limited.

Aged↗

PubMed1997

Developing a population-based registry for patients with paraproteinemias or multiple myeloma.

The development of a population-based registry on paraproteinemia and multiple myeloma is described. A unique feature of this registry is the multidisciplinary approach to obtain and collect new cases. Clinical chemists, internists, hematologists, and pathologists could all enter patients. All patients newly diagnosed in the mid-western part of The Netherlands (1.7 million inhabitants in 1992) with a paraproteinemia or multiple myeloma in 1991, 1992, and 1993 were included. The project was composed of a registry of clinical and laboratory data extracted from the patient's records, storage of 1 ml serum at diagnosis, and a yearly follow-up. A total of 1832 entries was received, of which 83% met the inclusion criteria. Comparison of this database with the Regional Cancer Registry showed that the paraprotein registry was successful as far as registration of myeloma patients was concerned. We conclude that the multidisciplinary approach used in this paraprotein registry is feasible and has resulted in a unique collection of patients for studying potential pre-malignant conditions such as paraproteinemia.

Diagnosis, Differential↗

PubMed1997

Blood and marrow transplantation activity in Europe 1995. European Group for Blood and Marrow Transplantation (EBMT).

In 1995, a total of 12,101 blood or marrow transplants, performed in Europe by 343 teams from 31 countries, were reported to the European Group for Blood and Marrow Transplantation (EBMT). Of these, 3858 (32%) were allogeneic, 8243 (68%) autologous transplants. Of the autologous transplants 1384 (17%) were bone marrow derived, 6504 (79%) from peripheral blood stem cells and 355 (4%) combined bone marrow and peripheral blood stem cell transplants. Of the allogeneic transplants, 571 (15%) were peripheral blood stem cell transplants, the remainder, 3287 (85%) bone marrow transplants. Main indications were leukemias with 4408 transplants (36%), 2977 allogeneic (68%) and 1431 autologous (32%); lymphomas with 4671 transplants (39%), 272 allogeneic (6%) and 4399 autologous (94%); severe aplastic anemia with 237 transplants (2%), 237 allogeneic (100%) and 0 autologous (0%); solid tumors with 2399 transplants (20%), 17 allogeneic (1%) and 2382 autologous (99%); and congenital disorders with 294 transplants (2%), 294 allogeneic (100%) and 0 autologous (0%) and others with 92 transplants (1%), 61 allogeneic (66%) and 31 autologous (34%). There were major differences between participating countries. The absolute numbers of teams and transplants per country differ widely and range from 0.2 to 33.3 teams per 10 million inhabitants (median 5.8); 3.2 to 733.3 total transplants per 10 million (median 200); 0.7 to 210 allogeneic transplants per 10 million (median 65); 0.3 to 700 autologous transplants per 10 million (median 122); 0 to 47.7 unrelated transplants per 10 million inhabitants (median 8.7). There is also a difference in the relative number of transplants for the individual indications. The coefficient of variation for selected diseases was calculated for those 14 countries with a minimum of 100 transplants. A narrow coefficient of variation indicates consensus amongst grafting physicians. It is narrowest for chronic myeloid leukemia in allogeneic transplants (36.7%) and for Hodgkin's disease in autologous transplants (44.8%). These data reflect the present status of blood and marrow transplantation in Europe and provide a basis for patient counselling and health care planning.

Anemia, Aplastic↗

PubMed1997

Haploidentical family member transplants for patients with chronic myeloid leukaemia: a report of the Chronic Leukaemia Working Party of off European Group for Blood and Marrow Transplantation (EBMT).

Within the registry of the chronic leukaemia working party of the European Group for Blood and Marrow Transplantation, data were available from 103 patients with chronic myeloid leukaemia who were treated by bone marrow transplantation from haploidentical family members. The patients of median age 30 years were transplanted between 1983 and 1994 in 25 European centres. The overall probabilities of survival and leukaemia-free survival (LFS) at 5 years were 32 and 25%, respectively. In univariate analysis, two factors were identified which affected survival and LFS, ie the state of disease at the time of transplant and the degree of HLA disparity. Fifty-nine patients were transplanted in first chronic phase and the probability of survival at 2 years was 47%. Forty-four patients received their transplants for advanced disease and their probability of survival at 2 years was 25% (P = 0.004). Donor bone marrow was HLA-mismatched for 0-1 antigens in 54 patients (group 1) and for 2-3 antigens in 49 patients (group 2). At 2 years, the probabilities of survival for groups 1 and 2 were 46 and 27% (P < 0.02) and the probabilities of LFS were 43 and 24% (P < 0.03), respectively. Multivariate analysis confirmed the prognostic importance of the disease stage and of the HLA disparity. Patients transplanted in first chronic phase from a donor mismatched for 0-1 HLA antigens had a probability of survival of 52% at 2 years compared with 19% for patients transplanted in advanced disease stage from donors mismatched for 2-3 HLA antigens.

Adolescent↗

PubMed1997

Long-term results after allogeneic bone marrow transplantation for chronic myelogenous leukemia in chronic phase: a report from the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.

The purpose of this study was to determine the long-term results of allogeneic bone marrow transplantation for chronic myeloid leukemia. A retrospective analysis was carried out of the outcome of 373 consecutive transplants performed at 38 European institutions between 1980 and 1988 and reported to the registry of the European Group for Blood and Marrow Transplantation. All transplants were carried out for first chronic phase of chronic myelogenous leukemia using unmanipulated marow cells from HLA-identical sibling donors. The probability of survival and leukemia-free survival at 8 years were 54% (95% CI: 49-59) and 47% (95% CI: 41-52) respectively. The probabilities of developing acute GVHD (II-IV) at 100 days and chronic GVHD at 4 years after transplant were 47% (95% CI: 41-53) and 52% (95% CI: 46-58) respectively. The probabilities of transplant-related mortality and leukemic relapse 8 years after BMT were 41% (95% CI: 36-48) and 19% (95% CI: 14-25), respectively. Transplant within 12 months of diagnosis was associated with reduced transplant-related mortality (34 vs 45%, P = 0.013) and resulted in improved leukemia-free survival (52 vs 44%, P = 0.03). The probability of relapse was significantly reduced in patients who developed chronic GVHD (RR = 0.33, P = 0.004). The probability of relapse occurring more than 2 years after transplant was increased more than five-fold in patients transplanted from a male donor (RR = 5.5, P = 0.006). Sixty-seven patients in hematologic remission were studied for residual disease by two-step RT/PCR for BCR-ABL mRNA and 61 (91%) tested negative. We conclude that bone marrow transplantation can induce long-term survival in approximately one-half of CML patients; the majority of survivors have no evidence of residual leukemia cells when studied by molecular techniques. The probability of late relapse is increased with use of a male donor.

Adolescent↗

PubMed1997

A population-based registry on paraproteinaemia in The Netherlands. Comprehensive Cancer Centre West, Leiden, The Netherlands.

Patients with monoclonal gammopathies comprise a heterogenous group. The few studies on incidence and follow-up are single-centre-based and may reflect referral bias. To avoid this, all patients (n=1275) in midwestern Netherlands with a newly discovered paraproteinaemia in 1991, 1992 and 1993 were included in a population-based registry and divided into four major diagnostic groups: multiple myeloma and plasmacytoma (n=230, 18%), other haematological diseases (n=141, 11%), paraprotein-related internal diseases (n=191, 15%) and monoclonal gammopathy of undetermined significance (MGUS, n=713, 56%). To avoid a possibly erroneous diagnosis, patients who were classified as having MGUS but who did not undergo confirmatory bone marrow examination were included in a separate group 'provisional MGUS' (n=524, 41%), whereas patients who did were classified as having 'definite MGUS' (n=189, 15%). The 'provisional MGUS' patients were relatively older and had more often a poor performance status, but differences between this and the 'definite MGUS' group were otherwise small. Patients complaining of general malaise more often had a full work-up of their paraproteinaemia. Bone pain, hypercalcaemia, high total protein, and high ESR occurred predominantly in the myeloma group, whereas fever or infection was less often seen in these patients. This registry of patients with paraproteinaemias provided valuable data related to all different diseases associated with paraproteinaemia.

Adult↗

PubMed1997

The role of radioactive iodine in the treatment of advanced differentiated thyroid carcinoma.

OBJECTIVE: 131I therapy may be beneficial for patients with advanced differentiated thyroid cancer (DTC) but there have been relatively few studies of the prognostic factors which influence the outcome. We have evaluated differences in outcome in relation to histology, localization of tumour, differentiation grade, age and sex after 131I as the only secondary treatment for advanced stages of DTC. DESIGN: Retrospective study of a selected patient group treated according to a fixed protocol. PATIENTS: We studied the outcome in 86 patients with stage pN3, pT4 or pM1 out of total of 432 patients treated for DTC from 1970 until 1991. RESULTS: The overall cure rate of 131I therapy after a mean follow-up of 12.1 years was 50% (papillary 65% vs follicular 23%). The overall 5-year progression free survival (PFSR) was 66%. Three out of 11 patients with bone metastases from follicular cancer were cured after a mean dose of 13.2 GBq, significantly less than the average dose of 28.4 GBq given to all patients with bone metastases. In the univariate analysis of 5-year PFSR histology (papillary 79% vs follicular 43%), differentiation grade (well differentiated 81% and moderately differentiated 31%), tumour stage (pN3100%, pT4 77% and M1 48%), and age (< or = 60 years 85% vs > 60 years 46%) were significant prognostic factors. A multivariate analysis showed differentiation grade, histology and age to be significant prognostic variables for outcome (moderately vs well differentiated: RR = 3.16, follicular vs. papillary: RR = 2.56 and age > 60 vs age < or = 60: RR = 2.43). CONCLUSIONS: 131I can be an effective treatment in patients with advanced differentiated thyroid cancer at all sites and can cure, on average, 50% of all patients with advanced differentiated thyroid cancer.

Carcinoma, Papillary↗

PubMed1997

The relevance of various vulvar epithelial changes in the early detection of squamous cell carcinoma of the vulva.

The objective of this study is to evaluate the possible relevance of vulvar epithelial changes as a risk factor for squamous cell carcinoma of the vulva. The data of 66 women surgically treated for squamous cell carcinoma of the vulva have been analyzed. More than 6500 slides from the resection specimens were revised with special emphasis on concurrent epithelial changes. Synchronous epithelial changes were seen in 63 patients. Thirty-nine patients had synchronous vulvar intra-epithelial neoplasia grade 1 (VIN I), 10 VIN II and 13 VIN III. Thirty-one patients had synchronous lichen sclerosus and 49 squamous cell hyperplasia. The difference between the percentage of patients with epithelial changes diagnosed preceding their carcinoma (30%) and the percentage of patients that had synchronous epithelial changes after reviewing the specimen (95%) was striking. It was concluded that more careful diagnosis, treatment and follow-up of these conditions might lead to an earlier recognition of squamous cell carcinoma of the vulva and therefore to a better prognosis.

Journal Article↗

PubMed1997

Transfusion of red cells is associated with increased incidence of bacterial infection after colorectal surgery: a prospective study.

BACKGROUND: Several studies suggest that perioperative blood transfusion is a major independent risk factor for postoperative bacterial infections. Transfusion-induced immunosuppression is thought to mediate this effect. STUDY DESIGN AND METHODS: In a randomized clinical trial comprising 697 patients with colorectal cancer, the relationship between two types of red cell components (buffy coat-depleted packed red cells and white cell-reduced [filtered] packed red cells) and postoperative bacterial infections was analyzed. RESULTS: Both types of red cells appeared to be associated with a greater incidence of postoperative infection than was no transfusion (39 vs. 24%, p < 0.01). A dose-response relationship could be demonstrated: the corrected relative risk was 1.6 for 1 to 3 units of red cells and 3.6 for more than 3 units. Multivariate analyses identified the transfusion of red cells and tumor location as the only significant independent risk factors for postoperative bacterial infection. CONCLUSION: Because allogeneic white cells, plasma, microaggregates, citrate, and platelets could be ruled out as risk factors for transfusion-associated postoperative infections, it is hypothesized that the transfusion of red cells is a potentially detrimental factor that transiently impairs the clearance of bacteria by phagocytic cells.

Adenocarcinoma↗

PubMed1997

p53 protein overexpression, a frequent observation in squamous cell carcinoma of the vulva and in various synchronous vulvar epithelia, has no value as a prognostic parameter.

In this study we have investigated the prevalence of p53 overexpression in various vulvar lesions and its significance as a prognostic parameter in patients with vulvar carcinoma. Overexpression of p53 was studied in 66 patients with squamous cell carcinoma of the vulva and in the following synchronous epithelial lesions: intraepithelial neoplasia grade I (VIN I) (n = 33), VIN II (n = 11), VIN III (n = 16), lichen sclerosus (n = 30), squamous cell hyperplasia (n = 37), normal vulvar skin of patients with vulvar carcinoma (n = 55), and in 18 samples of normal skin from healthy controls. Survival curves of the p53-positive and p53-negative patients were compared using the log-rank test. The use of DO7, and anti-p53 monoclonal antibody, showed p53 overexpression in 35 (53%) specimens of carcinoma, in eight (27%) of lichen sclerosus, in five (14%) of squamous cell hyperplasia, in six (18%) of VIN I, in two (18%) of VIN II, in two (13%) of VIN III, and in seven (13%) specimens of normal vulvar skin. Staining of normal skin from healthy controls showed no p53 positive specimens. No relationship between expression of p53 and disease-free survival in patients with vulvar carcinoma was present. In malignant, synchronous premalignant and non-neoplastic epithelial disorders of the vulva, p53 overexpression is a frequent observation, indicating that the latter two groups have characteristics of premalignant lesions. In addition, p53 overexpression was not a useful prognostic parameter for patients with vulvar carcinoma.

Carcinoma, Squamous Cell↗

PubMed1997

Stepwise compared with rapid application of vacuum in ventouse extraction procedures.

OBJECTIVE: To compare a one-step (rapid) application of negative pressure (vacuum) with conventional stepwise application for ventouse extraction following a prolonged second stage of labour. DESIGN: Randomised controlled study. SETTING: Teaching Hospital. PARTICIPANTS: Forty-seven women were randomised to the rapid vacuum group and 47 to the stepwise group. MAIN OUTCOME MEASURES: Duration of ventouse procedure, effectiveness of methods of application, morbidity of mother and infant. RESULTS: There was no significant difference in frequency of detachment of the cup after rapid or stepwise application of vacuum. A reduction in mean duration of the ventouse procedure of 6 min was realised without significant difference in maternal or neonatal morbidity. CONCLUSION: Rapid application of vacuum significantly reduces the duration of a ventouse extraction procedure without compromise to efficiency and safety.

Acid-Base Equilibrium↗

PubMed1997

Complications of laparoscopy: a prospective multicentre observational study.

OBJECTIVE: To determine the incidence and describe the complications of laparoscopic procedures in The Netherlands. DESIGN: A nationwide prospective multicentre observational study. METHODS: Data on complications were registered from 1 January to 31 December 1994 by 72 hospitals. Any unexpected or unplanned event requiring intra-operative or post-operative intervention was defined as a complication. Complications were classified in two groups: approach and technique related complications. Complication rates were compared with these already published. RESULTS: Of 25,764 laparoscopic procedures, 145 complications occurred (rate 5.7 per 1000 [/1000]); two deaths occurred. In 84 women laparotomy was necessary (rate 3.3/1000). In 83 cases (57%; 95% CI for approach = 49-65%) the complication was caused by the surgical approach; in 62 cases (43%) the technique was at fault. Haemorrhage of the epigastric vein and intestinal injury, often requiring laparotomy (90% of cases) were the most frequently observed complications. The complication rate was 2.7/1000 for diagnostic laparoscopic procedures, 4.5/1000 for sterilisation and 17.9/1000 (chi 2 = 127; dF = 2; P < 0.001) for operative laparoscopy. The highest incidence was registered for complications occurring during laparoscopic (assisted) hysterectomy. Stepwise logistic regression analysis showed that previous laparotomy and surgical experience were associated with complications requiring laparotomy. CONCLUSIONS: Most complications occurred during operative laparoscopic procedures (rate 17.9/1000). Residents in training are required to learn diagnostic laparoscopy and sterilisation and this training programme results in a fall in the risk of the complications. However, operative laparoscopic procedures are still hazardous, especially laparoscopic hysterectomy. Women with a previous laparotomy are particularly at risk.

Female↗