Electrosurgical bipolar vessel sealing versus conventional clamping and suturing for vaginal hysterectomy: a randomised controlled trial.

OBJECTIVE: To compare the effects of electrical bipolar vessel sealing and conventional suturing on postoperative pain, recovery, costs and micturition symptoms in women undergoing vaginal hysterectomy. DESIGN: Randomised controlled trial. SETTING: Eight teaching hospitals in the Netherlands. POPULATION: One hundred women scheduled to undergo vaginal hysterectomy for benign conditions excluding pelvic organ prolapse. METHODS: Women were randomised to vessel sealing or conventional surgery. The quality of life related to pelvic floor function was assessed using validated questionnaires before surgery and 6 months after surgery. Pain scores and recovery were assessed using a diary, including daily visual analogue scale scores, starting from the day before surgery until 6 weeks after surgery. MAIN OUTCOME MEASURES: Visual analogue scale pain scores, surgery time, blood loss, complications, quality of life related to pelvic floor function and costs. RESULTS: The evening after surgery, women in the vessel-sealing group reported significantly less pain (5.7 versus 4.5 on a scale of 0-10, P = 0.03), but after that pain scores were similar. Operation duration was shorter for vessel sealing (60 versus 71 minutes, P = 0.05). Blood loss and hospital stay did not differ. We observed no major difference in costs between the two interventions (2903 versus 3102 €, P = 0.26). Changes in micturition and defecation symptoms were not affected by the surgical technique used. CONCLUSION: Using vessel sealing during vaginal hysterectomy resulted in less pain on the first postoperative day, shorter operating time, similar morbidity and similar pelvic floor function. No major differences in costs were found between the two interventions.

[Abdominal pain and transit disorders following a laparoscopic procedure: be alert to a trocar hernia]. / Buikpijn en passagestoornissen na een laparoscopische ingreep: denk aan een trocart-hernia.

Three patients, three women aged 40, 64 and 75, suffered from a trocar hernia, a specific complication of laparoscopic surgery. This type of hernia may result in small bowel obstruction and normally appears within two weeks after laparoscopy. The usual presentation is that of abdominal pain with nausea and vomiting. Trocar herniation implicates the necessity of reposition and might result in bowel resection with prolonged hospital stay. The advice for prevention is to use a trocar with a diameter as small as possible, as the chance of a hernia occurring increases withthe use of larger trocars. Fascial closure is advised for trocars to mm and larger. With a growing number of procedures being performed laparoscopically, the importance of recognizing and preventing this complication is evident. Three cases illustrate the importance of early recognition of small bowel obstruction resulting from trocar herniation.

A randomized comparison of post-operative pain, quality of life, and physical performance during the first 6 weeks after abdominal or vaginal surgical correction of descensus uteri.

AIMS: With respect to urogenital function, vaginal hysterectomy combined with anterior and/or posterior colporraphy has been shown to be superior to abdominal sacrocolpopexy with preservation of the uterus. We performed a randomized trial to compare the effects of both procedures on pain, quality of life and physical performance during the first six weeks after surgery. METHODS: Eighty-two patients were randomized to have surgery either by vaginal or abdominal approach. All patients were asked to complete the RAND-36 before surgery and 6 weeks after surgery and to keep a diary for the first 6 weeks after surgery. This diary assessed the pain perception and use of pain medication, bother of limitations due to the surgery and performance of daily activities after surgery. These outcomes were compared. RESULTS: All patients completed the RAND-36 and 68 patients completed the diary. Patients who had undergone abdominal surgery had a statistically lower score on the health change domain (56 vs 68), bodily pain domain (63 vs 80) and mental health domain (74 vs 81) of the RAND-36, as compared to patients who had undergone vaginal prolapse surgery. During hospital stay, the abdominal group experienced on average more days of pain (4.5 vs 3.0) and impaired mobility (3.7 vs 2.9) as compared to the vaginal group. Patients received more pain medication following abdominal surgery as compared to vaginal surgery. CONCLUSIONS: The vaginal operation to correct a descensus uteri is associated with less pain, better quality of life and better mobility during the first 6 weeks of the recovery period as compared to the abdominal approach.

The effect of low-dose 3-keto-desogestrel added to a copper-releasing intrauterine contraceptive device on menstrual blood loss: a double-blind, dose-finding, placebo-controlled study.

OBJECTIVE: We sought to establish the lowest dose of 3-keto-desogestrel, when added to a copper-releasing intrauterine contraceptive device, that is needed to reduce menstrual blood loss to a very low level and to treat (essential) menorrhagia successfully. STUDY DESIGN: A double-blind group comparative study was designed in which 203 healthy women with or without menorrhagia were enrolled and randomized to four different Multiload Cu250 intrauterine contraceptive devices, releasing 0 (control), 1.5, 3, or 6 microg of 3-keto-desogestrel daily. Menstrual blood loss, hemoglobin, and serum ferritin levels were determined before and during treatment. RESULTS: All 3-keto-desogestrel-copper intrauterine contraceptive devices reduced menstrual blood loss significantly, causing a reduction of up to 30 to 40 mL after 12 months of use. All women with essential menorrhagia were considered to have been successfully treated after 6 months of use. Serum ferritin levels rose with all three 3-keto-desogestrel-loaded devices. CONCLUSION: A Multiload Cu250 intrauterine contraceptive device releasing 1.5 microg of 3-keto-desogestrel daily is able to reduce menstrual blood loss to a very low level and to replete body iron stores in women with or without menorrhagia. Higher doses have no superior effect.

Histological patterns in endometrial samples from perimenopausal women.

OBJECTIVE: Evaluation of endometrial histology patterns in perimenopausal women. METHODS: Endometrial biopsies (202) taken from perimenopausal women by suction curette were assessed by light microscopy. RESULTS: Out of 142 adequate specimens a total of 82 (57.7%) specimens could not be classified in the well-defined categories of the fertile period because of mixed histological patterns. Of the 142 specimens, 59 (41.5%) showed abnormal secretory endometrium, three (2%) disordered proliferative endometrium and 20 (14.1%) a mixture of non-secretory and secretory endometrium. CONCLUSION: The often used histological classification for endometrium, with well-defined regular patterns based on normal cyclic changes, often does not apply to endometrial tissue obtained from perimenopausal women due to a mixed pattern within one biopsy.

Bleeding patterns and endometrial histology during administration of low-dose estradiol sequentially combined with dydrogesterone.

OBJECTIVE: To determine bleeding patterns and endometrial response in postmenopausal women taking low-dose (1 mg) estradiol in a sequential combined formulation with 5 or 10 mg dydrogesterone. METHODS: A total of 151 postmenopausal women were allocated randomly to 5 or 10 mg dydrogesterone during cycle days 15-28 in a sequential oral formulation with 1 mg estradiol continuously during 13 cycles of 28 days. Occurrence of vaginal bleeding was recorded daily and analyzed in accordance with World Health Organization (WHO) standards. Endometrial biopsies, obtained at baseline and cycle days 25-27 of the final treatment cycle, were interpreted independently by two pathologists. RESULTS: The study was completed by 131 women (87%). The percentage of women with bleeding (mean +/- SD) was 57.2 +/- 3.6% in the 1/5-mg group and 65.8 +/- 4.2% in the 1/10-mg group (p < 0.001); cross-sectional analysis showed that, in every cycle, there were more women with bleeding in the 1/10-than in the 1/5-mg group (p < 0.001). With regard to the day of onset of bleeding, the mean difference between groups was 1.4 +/- 1.1 days (p < 0.001). There was no difference in duration of bleed (5 days), or intensity or incidence of intermittent bleeding (3-14% per cycle). Both regimens resulted in high rates of amenorrhea in each cycle (26-49%), but only 14/151 (9%) women were amenorrheic throughout. Three patients (2%) discontinued owing to bleeding problems. Endometrial protection was adequate in 98.3% (1/5-mg group) and 98.5% (1/10-mg group) with only one case of proliferation (1/10-mg group) and one of simple hyperplasia (1/5-mg group). CONCLUSIONS: The bleeding pattern associated with low-dose (1 mg) estradiol sequentially combined with 5 or 10 mg dydrogesterone shows a high rate of amenorrhea in each cycle; there is a dydrogesterone dose effect on the occurrence and day of onset of bleeding. Bleeding episodes that occur show a regular pattern and are of slight intensity. The endometrial safety of both regimens is high.

No interaction between ciprofloxacin and an oral contraceptive.

Several antibiotics have been reported to lessen the ovarian suppression produced by oral contraceptive agents, as a result of drug interactions. The present investigation was designed to study the likelihood of the occurrence of any such interaction between the fluoroquinolone antibiotic ciprofloxacin (Ciproxin) at a dosage of 500 mg twice a day and the "low-dose" oral contraceptive Marvelon (30 microgram of ethinyl estradiol [EE] plus 150 microgram of desogestrel). Twenty-four healthy female volunteers were studied in a double-blind, placebo-controlled, randomized crossover trial. There were no significant differences between measurements of the area under the concentration-time curve of EE up to 24 h after oral contraceptive intake during placebo and ciprofloxacin administration on days 11 and 16 of the cycles, indicating the absence of pharmacokinetic interaction. Similarly, no clinically significant differences in the levels of sex hormone binding globulin were found between the placebo and ciprofloxacin cycles, indicating no major variation in EE levels during ciprofloxacin and placebo treatment. Ten subjects in each of the placebo and ciprofloxacin groups had early-follicular-phase levels of 17-beta estradiol (<184 ng/liter) at one or more points during their cycles, but none had values above the early-follicular-phase range, indicating no significant ovarian activity. In addition, all subjects had progesterone levels of <2 ng/ml, indicating the absence of ovulation. Only two subjects, who received the placebo, had evidence of sustained follicular growth to a potentially ovulatory follicle ( approximately 18 mm). We conclude that ciprofloxacin does not interfere with the ovarian suppression produced by the low-dose oral contraceptive Marvelon.

PIP: A single-center, double-blind, placebo-controlled randomized crossover trial involving 24 healthy female volunteers, aged 19-32 years, was undertaken to assess whether ciprofloxacin (Ciproxin) affects the contraceptive effect of Marvelon (30 mcg of ethinyl estradiol [EE] plus 150 mcg of desogestrel). The study also evaluated the follicle ripening in ovaries by measuring the increase in mean follicular diameter in the subovulatory cycles during treatment with ciprofloxacin. The volunteers were divided into 2 blocks of 12 individuals, randomly allocated to 1 of 2 treatment order groups, with 6 individuals per group. One group received Marvelon, 1 tablet daily on days 8-28 of each cycle, and Ciprofloxacin or the placebo group administered twice daily on days 8-17 of cycles. Findings revealed that there were no significant differences between measurements of the area under the concentration-time curve of EE up to 24 hours after oral contraceptive intake during placebo and ciprofloxacin administration on days 11 and 16 of the cycles, indicating the absence of pharmacokinetic interaction. Similarly, no clinically significant differences in the levels of sex hormone binding globulin were found between the placebo and ciprofloxacin cycles, indicating no major variation in EE levels during ciprofloxacin and placebo treatment. In conclusion, ciprofloxacin does not appear to alter ovarian activity when co-administered with the low-dose oral contraceptive Marvelon. No evidence of pharmacokinetic interaction between the antibiotic and the contraceptive was detected.

Reconsidering menorrhagia in gynecological practice. Is a 30-year-old definition still valid?

OBJECTIVE: To determine whether the 30-year-old definition of menorrhagia (menstrual blood loss of 80 ml or more) is still valid in gynecological practice today. STUDY DESIGN: Of 313 Dutch women, recruited from gynecological practice, the menstrual blood loss of one bleeding episode was objectively measured and related to the women's hemoglobin concentrations as well as their serum ferritin levels. Also, the 95th percentile of menstrual blood loss was calculated of women with normal hematological parameters, representing an upper normal limit. RESULTS: The percentage of women suffering from anemia exceeded the overall mean above 120 ml of menstrual blood loss. The 95th percentile of menstrual blood loss of women with normal hemoglobin concentrations (12 g/dl or above) and with normal serum ferritin levels (16 microg/l or above) was 115 ml. CONCLUSION: The risk of developing anemia from heavy menstrual bleeding is substantially increased at a menstrual blood loss level of 120 ml, and not, like the current definition of menorrhagia suggests, at 80 ml.

Menorrhagia--a search for epidemiological risk markers.

OBJECTIVE: To isolate epidemiological risk factors for menorrhagia. METHODS: Menstrual blood loss (MBL) of one bleeding episode of 182 healthy women was measured with the alkaline hematin method and the results were related to age, parity, body mass index and smoking habits. Multiple and logistic regression analysis was performed to isolate the variables that most influence MBL. Two consecutive menstrual episodes were measured in 117 women, to determine individual constancy. RESULTS: MBL increased significantly with age (Kruskal-Wallis, P < 0.03) and the percentage of women with menorrhagia was significantly higher above 40 years of age (Mann-Whitney's ranks sum test, P < 0.05). The odds ratio of parous:nulliparous women for menorrhagia was 2.27:1, but after adjustment for age this influence disappeared. Body mass index and smoking habits were not significantly related to menorrhagia. The mean difference between the MBL of two consecutive menstruations is 2.1 ml (S.E.: 1.7, 95% CI: -1.3 to 5.5 ml). CONCLUSIONS: Only age could be indicated as a risk marker for menorrhagia. Parity, body mass index and smoking habits appear to have no significant effect on MBL, when adjusted for age. The individual constancy in MBL between two consecutive cycles is very high and therefore one single measurement suffices in studies of MBL.

Successful catheter drainage of recurrent benign multicystic mesothelioma of the peritoneum.

The case history of a patient with pulmonary embolism 4 months following a kidney transplantation is presented. Ultrasonography of the abdomen suggested a large ovarian tumour for which she had a laparotomy. Histological examination after resection of the tumour revealed a benign multicystic mesothelioma of the peritoneum. During the course of 1 year the tumour recurred 5 times and different attempts to aspirate and obliterate the cyst were ineffective. Eventually, cure was achieved by permanent transvaginal catheter drainage, which resulted in infection and obliteration of the cyst.

[Puerperal fever: an old enemy in aggressive form]. / Kraamvrouwenkoorts: een oude vijand in een agressieve vorm.

Two previously healthy women, aged 30 and 35 years, suffered pain in the lower abdomen, one before and the other after spontaneous delivery at 40 and 33 4/7 weeks of amenorrhoea, respectively, while a third woman, aged 33, at 36 weeks of amenorrhoea developed pain in the lower abdomen, fever, vomiting, and diarrhoea. All three women were found to have a uterine infection caused by streptococci of Lancefield group A (group A Streptococcus, GAS). In one woman, the diagnosis was made rapidly so that antibiotic treatment could be instituted in time; the other two developed sepsis and multiorgan failure, with a fatal issue in one of them. The three children also were septic, two recovered after treatment and one died. Since the eighties, serious GAS infection has been on the increase. The worst manifestation is the toxic shock syndrome caused by streptococci. Abdominal pains after delivery may be a first sign of this, and should not too readily be interpreted as just after pains. The condition may also develop before delivery. In view of the high mortality rate, early diagnosis and antibiotic treatment are of vital importance for mother and child.

A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss.

OBJECTIVE: To validate a simple, highly predictive test to discriminate between menorrhagia and normal menstrual blood loss. METHODS: The sanitary wear of 489 menstrual bleeding episodes was collected by 288 women for objective measurement of menstrual blood loss (alkaline hematin method); the women made a subjective assessment of the volume and, based on a pictorial chart, recorded the amount of and the degree to which their sanitary wear was soiled. Based on that degree, a score was calculated for each episode and a suitable cutoff point was chosen, above which the presence of menorrhagia was likely and below which it was unlikely. RESULTS: Using a score of 185 as the cutoff point, the predictive values of positive and negative tests were almost equally high, 85.9 and 84.8%, respectively. Whether or not the presence of clots was recorded, these values did not change. The predictive value of a woman's complaint of heavy bleeding for the presence of menorrhagia was 55.9% and that of anemia (hemoglobin less than 12.0 g/dL) was 74.4%. CONCLUSION: We validated and refined a new, simple, visual assessment technique and demonstrated that it is superior to a woman's subjective assessment of menstrual blood loss and the occurrence of anemia for predicting menorrhagia, even if it is performed only once. We also demonstrated that the volume that clots contribute to menstruation is not as large as many clinicians believe. With this technique, the quality of therapy can be enhanced by making it more adequate and rational.

Surgical support and suspension of genital prolapse, including preservation of the uterus, using the Gore-Tex soft tissue patch (a preliminary report).

Abdominal-retroperitoneal sacral genito-colpopexy using the expanded polytetrafluoroethylene (ePTFE) soft tissue patch has been found to be highly effective for repair of genito-vaginal prolapse. We treated 61 patients in this way, including patients who had failed multiple previous attempts at repair. At a mean of 32 months of follow-up, more than 95% of patients were still classified as successfully treated. To preserve the uterus in cases of complete genito-vaginal prolapse, we have developed a new surgical technique, which we describe in this paper.

Menorrhagia. Current drug treatment concepts.

Since menorrhagia occurs in 9 to 14% of populations of healthy women, many general practitioners will encounter menorrhagia-related problems. Menorrhagia is difficult to objectify and the choice of treatment between the available drugs is not always an easy one. In this survey, the available knowledge on menorrhagia diagnosis, underlying pathophysiology and treatment, especially medicinal treatment, are discussed. Overall, a practical approach is emphasised. The desire for contraception as well as the underlying cause of menorrhagia determine the drug of choice in the treatment of menorrhagia. If contraception is desired, oral combination contraceptives and continuously dosed progestogens, orally or as a medicated intrauterine device (IUD), are the first choice drugs for essential menorrhagia, and for fibroid- and bleeding disorder-associated menorrhagia. If no contraception is desired, the first choice treatments are drugs that need to be administered only during menstruation, such as prostaglandin synthesis inhibitors or antifibrinolytics. Of these, antifibrinolytics reduce menstrual blood loss to the greatest extent, whereas prostaglandin synthesis inhibitors have the lowest incidence of side effects. Prostaglandin synthesis inhibitors also have the extra advantage of diminishing dysmenorrhoea. There is no place for ergometrine in the treatment of menorrhagia. No studies are available as yet on the combination of various drug treatment modalities, although such an evaluation would be desirable.

Intrauterine steroid contraceptives.

Progestagen releasing IUDs were specially developed to diminish the problems of bleeding and pain with inert and copper containing IUDs. The intrauterine release of the progestagen causes endometrial atrophy, resulting in impairment of nidation, and interferes with transport of the ovum and the spermatozoa. Two available types, Progestasert, Biograviplan (Alza Corporation, California; Grünenthal) and Levonorgestrel Nova-T (Leiras Pharmaceuticals, Finland), have been sufficiently tested in multinational trials. Compared with Progestasert, LNG Nova-T showed lower pregnancy rates (Pearl Index 0.30), less risk for ectopic pregnancy and a longer effective lifetime (7 years). With both IUDs the amount and duration of menstrual blood loss is decreased. Amenorrhea is a frequent occurring side effect of LNG Nova-T, caused by endometrial atrophy. Intermenstrual blood loss and spotting incidences are not uniformly reduced and are still a frequent reason for removal. Preinsertion counselling may improve the acceptance of these non-health-threatening side effects. With both IUDs a decrease of menstrual cramps during periods is percepted and a low incidence of PID is found. Basically, the progestagen releasing IUD can be recommended to all women who wish an IUD for contraception and to women with contraindications for oral contraceptives, especially to those with menorrhagia, anaemia or risk for anaemia.

PIP: Progestagen-releasing IUDs were developed to diminish the problems of bleeding and pain with inert and copper-containing IUDs. The intrauterine release of the progestagen causes endometrial atrophy, resulting in impairment of nidation, and interferes with transport of the ovum and the spermatozoa. 2 available types, Progestasert, Biograviplan (Alza Corporation, California; Grunenthal) and Levonorgestrel Nova-T (Leiras Pharmaceuticals, Finland), have been sufficiently tested in multinational trials. Compared with Progestasert, LNG Nova-T showed lower pregnancy rates (Pearl Index 0.30), less risk for ectopic pregnancy, and a longer effective lifetime (7 years). With both IUDs, the amount and duration of menstrual blood loss is decreased. Amenorrhea is a frequently occurring side effect of LNG Nova-T, caused by endometrial atrophy. Intermenstrual blood loss and spotting incidences are not uniformly reduced and are still a frequent reason for removal. Preinsertion counseling may improve the acceptance of these nonhealth threatening side effects. With both IUDs, a decrease in menstrual cramps during periods is perceived and a low incidence of PID is found. Basically, the progestagen-releasing IUD can be recommended to all women who wish an IUD for contraception and to women with contraindications for OCs, especially to those with menorrhagia, anemia, or risk for anemia. (author's)

The alkaline hematin method for measuring menstrual blood loss--a modification and its clinical use in menorrhagia.

Direct measurement of menstrual blood loss is the only reliable basis of the diagnosis 'menorrhagia'. We describe modifications of the alkaline hematin method for measuring menstrual blood loss (MBL) which improve the recovery rate from 89 to 98% and make the method more suitable for routine laboratory use. Using this modified method, 5 out of 21 patients (24%) complaining of menorrhagia and scheduled for hysterectomy had an MBL less than 80 ml, which is the upper level of normal MBL.