A randomized comparison of continuous versus interrupted mass closure of midline incisions in patients with gynecologic cancer.

OBJECTIVE: To address the incidence of deep wound dehiscence and incisional hernia formation with two types of mass closure after vertical midline laparotomy performed in patients with gynecologic cancer. METHODS: Continuous and interrupted mass closures were compared randomly in 632 patients. Both methods were performed with absorbable material. Of the 614 subjects who could be evaluated, 308 underwent a continuous, non-locking closure with looped polyglyconate suture, and 306 were closed with interrupted polyglycolic acid according to the Smead-Jones technique. RESULTS: Three (1%) subjects with the continuous closure and five (1.6%) with the interrupted closure had an abdominal wound infection (P = .50). One patient whose incision was closed with continuous suturing had a deep wound dehiscence (without evisceration). The follow-up period was 6 months to 3 years. No patient had evidence of chronic sinus drainage. Thirty-two (10.4%) of the patients who had the continuous closure and 45 (14.7%) of those who were closed with the interrupted method had evidence of incisional hernia (P = .14). No hernia developed in any patient with a wound infection. Four (1.3%) hernias after the continuous closure and eight (2.6%) after the interrupted closure required surgical repair because of patient discomfort (P = .38). CONCLUSION: The interrupted closure was not superior to the continuous closure for short- and long-term wound security. The continuous method was preferable because it was more cost-efficient and faster.

Surgery for genitourinary prolapse and stress incontinence: a randomized trial of posterior pubourethral ligament plication and Pereyra suspension.

OBJECTIVE: Our purpose was to compare two antiincontinence procedures in patients with severe genitourinary prolapse and coexisting clinical or potential stress incontinence. STUDY DESIGN: In addition to cystopexy, 109 patients with a urethrocystocele of grade 2 or more and a positive stress test result with prolapse reduction received posterior pubourethral ligament plication or Pereyra suspension. RESULTS: Of 55 patients undergoing posterior pubourethral ligament plication, 15 were clinically and 40 potentially incontinent; the same figures were 21 and 33, respectively, among 54 patients undergoing the Pereyra procedure. Follow-up was for 3 to 9 years. Subjective (60% vs 71%, p = 0.72) and objective (27% vs 57%, p = 0.14) cure rates were not statistically different among patients who were clinically incontinent (posterior pubourethral ligament plication vs Pereyra suspension). Among potentially incontinent patients, subjective (85% vs 100%, p = 0.03) and objective (50% vs 76%, p = 0.04) continence rates were higher after the Pereyra procedure. Overall, the cotton swab test had negative results (maximum straining angle < or = 30 degrees) after successful surgery in 79% and 96%, respectively, of patients (p = 0.03). Four subjects (7%) underwent removal of one Pereyra suture because of urinary retention or suprapubic wound infection. CONCLUSION: Cystopexy with Pereyra suspension is recommended, particularly for patients with prolapse and potential stress incontinence.

A randomized trial of open versus closed vaginal vault in the prevention of postoperative morbidity after abdominal hysterectomy.

OBJECTIVE: Our purpose was to evaluate the effects of two surgical techniques, closed vaginal vault with two layers of continous 3-0 polyglactin suture versus open vaginal vault with a locking 3-0 polyglactin suture, after abdominal hysterectomy. STUDY DESIGN: A prospective, randomized trial was performed. During the hospital stay and 4 to 8 weeks after the operation patients were observed for evidence of morbidity. RESULTS: Of the 273 evaluable subjects, 141 had the vaginal vault left open whereas 132 were closed. Ten (7.1%) and eight patients (6.1%) had infections at the operative site (pelvis or abdominal wound) (p = 0.92). A urinary tract infection was diagnosed in three (2.1%) and in four subjects (3.0%) (p = 0.46). A pelvic hematoma developed in two patients of each group (p = 0.66). Vault granulations were recorded in 11% and 12% of subjects (p = 0.97). CONCLUSIONS: This study failed to show some benefit in favor of either of the two surgical policies. A careful surgical technique and antibiotic prophylaxis seem to remain the most important factors in the prevention of postoperative morbidity.

Pre-operative morphological and colour Doppler features of borderline ovarian tumours.

OBJECTIVE: To evaluate pre-operatively the sonographic morphology and colour Doppler findings of borderline ovarian tumours and to compare these findings to those of benign and malignant tumours. METHODS: Pre-operative transvaginal and colour Doppler ultrasound examinations were performed on 150 women with adnexal tumours. Pulsatility index, resistance index, peak systolic velocity, site, number and confluence of vessels were recorded. RESULTS: Fifty-six women had malignant ovarian tumours, 74 had benign and 20 had borderline tumours. No biological, morphological or demographic parameters were specifically predictive of borderline tumours. Intratumoral vessels with a pulsatility index of below 1.0 were observed in 19 of the 20 borderline tumours; a morphological score suggested malignancy in 15 women whereas the CA125 exceeded 30 u/ml in 10 cases. Confluence of blood vessels was observed only in three cases. A model including intracystic complexity (either vegetations or septa), pulsatility index of less than 1.0, absence of confluence of vessels, CA125 of less than 150 u/L, in a woman under 60 years of age allowed borderline tumours to be detected with 85% sensitivity, 92% specificity and 91% accuracy. CONCLUSION: Borderline tumours have haemodynamics resembling those of malignant tumours but the distribution of vessels is often similar to that observed in benign tumours; this observation should be considered when proposing multiparameter scoring systems including colour Doppler ultrasound to identify malignancies of the ovary. Colour Doppler findings may be of assistance in the follow up of women after conservative surgery for ovarian malignancies.

Effectiveness of autologous blood transfusion in patients undergoing radical hysterectomy.

Autologous blood transfusion (ABT) is a safe and useful procedure in patients undergoing elective surgery, but it has not been recommended for radical hysterectomy with pelvic lymphadenectomy. We retrospectively evaluated the results of an ABT programme in 146 consecutive women undergoing radical hysterectomy and pelvic lymphadenectomy for cervical carcinoma at our institution. Forty women underwent autologous blood transfusion after predeposit; 23 underwent preoperative normovolemic haemodilution; 38 were eligible but could not receive autologous blood transfusion for logistic reasons; 45 were excluded for medical reasons. 126 units of blood were collected, of which 100 (80%) were reinfused. The donation procedure was well-tolerated and no transfusion reaction was observed. Homologous blood transfusion was needed in 13% of patients receiving predeposit or haemodilution (8/63), in 42% of patients that were eligible but not receiving autologous blood transfusion (16/(38), and in 71% of non-eligible patients (32/45). The total number of units of homologous blood required for transfusion was lower in patients undergoing predeposit or haemodilution (14) than in those included in the observation arm (43). Autologous blood transfusion is a safe practice which greatly reduces the need for homologous blood transfusion, and radical hysterectomy with pelvic lymphadenectomy represents an adequate indication for this procedure, as the majority of deposited blood is actually reinfused.

Burch colposuspension versus modified Marshall-Marchetti-Krantz urethropexy for primary genuine stress urinary incontinence: a prospective, randomized clinical trial.

OBJECTIVE: Our purpose was to compare the effects of the Burch colposuspension with those of the modified Marshall-Marchetti-Krantz urethropexy. STUDY DESIGN: Eighty women underwent the two types of operation. A full urodynamic investigation was repeated 6 months after surgery. RESULTS: Clinical follow-up continued for 2 to 7 years. Differences in subjective and objective cure rates were not statistically significant (respectively, 92% and 80% for the Burch colposuspension and 85 and 65% for the modified Marshall-Marchetti-Krantz urethropexy). The latter induced a longer hospital stay (7.4 vs 6.3 days, p = 0.001), a later resumption of spontaneous voiding (13.8 vs 8.5 days, p = 0.002), and was associated with considerable complications (one case of blood replacement for retropubic hematoma, one case of severe voiding difficulty, one case of further treatment for stress incontinence, and three cases of symptomatic de novo detrusor instability). CONCLUSION: For its high cure rate, short time to resumption of spontaneous voiding, short hospital stay, and low associated morbidity, the Burch colposuspension should remain the procedure of choice for stress incontinence.

Pefloxacin in the treatment of severe infections in gynecological cancer patients.

Infections often complicate the medical or surgical treatment of hospitalized cancer patients. In these cases, a broad-spectrum antibiotic treatment is necessary before the microbiological results are available. The aim of the present study is to verify the efficacy of pefloxacin as empirical antibiotic therapy in controlling infectious complications induced by surgery, chemotherapy or radiotherapy in female patients with gynecological cancer. To this purpose, 58 hospitalized patients with gynecologic malignancy and severe infectious complications were treated with intravenous pefloxacin at the dosage regimen of 400 mg every 12 hours. In all, 49 (or 91%) of the 54 evaluable patients were cured. The mean duration of successful treatment was 5.9 +/- 2.1 days (ranging 4-13 days). No side effects or clinical laboratory abnormalities requiring reduction or discontinuation of therapy were observed. We conclude that pefloxacin may be considered a first choice, broad-spectrum, single antibiotic for use in the empirical therapy of infections in gynecological cancer patients.

Piperacillin versus cefotetan as single-dose prophylaxis in abdominal hysterectomy: a prospective, randomized, multicenter study.

Five hundred and sixty-six women, consecutively admitted to nine different hospitals for elective abdominal hysterectomy, were randomized to receive a single 2 g i.v. dose of either cefotetan or piperacillin at induction of anesthesia. Five patients were excluded and 561 (287 given cefotetan and 274 given piperacillin) could be evaluated. In 10 patients (5 for each drug) the concentrations of either cefotetan or piperacillin in serum and subcutaneous tissue at the beginning and at the end of surgery and in uterus, salpinx and ovary samples, were microbiologically assessed. No significant differences could be found between cefotetan and piperacillin groups for any of the considered infectious complications (bacteremia, wound or vaginal cuff infection, pelvic cellulitis and febrile morbidity) nor for the pooled data (cefotetan group: 4.9%, piperacillin group: 5.8%, p:NS). As for the concentrations of prophylactic drugs, serum levels throughout surgery were found to be adequate.

Multicenter trial of prophylaxis with clindamycin plus aztreonam or cefotaxime in gynecologic surgery.

A prospective, randomized, multicenter study was conducted on the efficacy and safety of two prophylactic antibiotic regimens in both abdominal and vaginal hysterectomy. Patients received three intravenous doses of clindamycin (900 mg) plus either aztreonam (1 g) or cefotaxime (1 g); the doses were given at the induction of anesthesia and 8 and 16 hours later. A total of 170 patients undergoing abdominal hysterectomy and 142 patients undergoing vaginal hysterectomy completed the trial and were evaluated. Following abdominal hysterectomy infections occurred at the operative site in 1.2% of patients given a regimen including aztreonam and in 4.7% of those given a regimen including cefotaxime; the difference between the two groups was not significant. Neither were significant differences observed in the incidence of fever, the incidence of bacteriuria, the need for postoperative antibiotics, or the duration of postoperative hospitalization, although results were slightly better for patients receiving clindamycin plus aztreonam. Following vaginal hysterectomy, slightly but not significantly better results for the same parameters were obtained in the group given clindamycin plus cefotaxime. Diarrhea was the only adverse reaction attributable to antibiotic treatment and occurred more frequently in patients given cefotaxime. It was concluded that the two regimens were similarly effective and safe in preventing infections following hysterectomy.

Cefotetan versus piperacillin in the prophylaxis of abdominal and vaginal hysterectomy: a prospective randomized study.

A prospective randomized study was carried out on a total of 686 patients who underwent vaginal or abdominal hysterectomy. Of these, 338 were given prophylactic cefotetan (2 g) and 348 piperacillin (2 g). Both drugs were administered as i.v. bolus 30 min before operation. Findings confirm the higher risk of infection with abdominal hysterectomy and the advantages of the long half-life cephalosporin, cefotetan.

Sulbactam/ampicillin versus cefotetan in the treatment of obstetric and gynecologic infections.

In an open, randomized clinical study, the safety and efficacy of sulbactam/ampicillin was compared to that of cefotetan in 95 hospital patients with gynecologic or obstetric infections. Sulbactam/ampicillin (1 g:2 g), was administered intravenously every 8 h to 46 patients, and cefotetan (2 g) was administered intravenously every 12 h to 49 patients. All 23 patients with obstetric infections and 18 of the 23 patients with gynecologic infections treated with sulbactam/ampicillin were evaluated as cured. All 21 patients with obstetric infections and 23 of the 28 patients with gynecologic infections treated with cefotetan were evaluated as cured. No side effects requiring discontinuation of therapy or reduction of the dose administered, were observed.

Comparison of flavoxate hydrochloride in daily dosages of 600 versus 1200 mg for the treatment of urgency and urge incontinence.

Flavoxate hydrochloride at a daily dosage of 600 mg was compared to a daily dosage of 1200 mg for the treatment of unstable bladder. Twenty-seven patients were treated for 4 weeks in a double-blind, randomized, parallel-group trial. Clinically, both schedules were equally successful. In urodynamic terms, however, particularly with respect to uninhibited detrusor contractions, 1200 mg/day was significantly superior to 600 mg/day. Tolerability was excellent for both regimens. The side-effect free treatment of urgency and urge incontinence is of paramount importance for a patient's quality of life.

Flavoxate hydrochloride for urinary urgency after pelvic radiotherapy: comparison of 600 mg versus 1200 mg daily dosages.

This preliminary communication reports on a non-randomized pilot type trial of 34 females with urgency after pelvic radiotherapy who were treated with flavoxate hydrochloride for 4 weeks. A dosage of 600 mg/day was given to 21 patients and 1200 mg/day to 13 patients. Clinically, both regimens achieved comparable results. Urodynamically (first desire volume, bladder capacity and pressure at capacity) treatment with 1200 mg/day was significantly superior to 600 mg/day. Both schedules were equally well tolerated by patients and no treatment interruption occurred. A randomized double-blind trial comparing 600 and 1200 mg/day flavoxate hydrochloride is currently underway the results of which will be reported in due course.

A double-blind trial of fentonium bromide in the treatment of incontinent unstable bladder.

The effects of fentonium were compared with those of placebo in a double-blind, cross-over trial involving 28 incontinent women with unstable bladder. Fentonium bromide proved significantly more effective in reducing urgency and urge incontinence (p less than 0.05), in reducing detrusor pressure rise during bladder filling (p less than 0.01) and in increasing bladder volume at first stimulus (p less than 0.05). Well tolerated, fentonium bromide proved useful in the treatment of unstable bladder.

Marshall-Marchetti-Krantz procedure and Burch colposuspension in the surgical treatment of female urinary incontinence.

Urinary stress incontinence was treated by the Marshall-Marchetti-Kranz (MMK) procedure in 42 and by Burch coloposuspension in 44 women. All were assessed preoperatively and for greater than 1 year postoperatively, both clinically and by urodynamic tests. Cure of incontinence was achieved to a similar extent by both procedures, in 71% after the MMK and 79% after the Burch operation. Results were better than average if there was no prolapse and if the bladder was stable preoperatively.