RESUMEN

BACKGROUND: We set out to investigate prospectively the morbidity rate for gynecological laparoscopy patients at a tertiary care center. METHODS: We prospectively recorded data on 743 laparoscopic procedures performed between January 1, 1992 and December 31, 1996. The procedures included 36 diagnostic laparoscopies (4.8%), 115 laparoscopies carried out for minor surgical acts (15.4%), 523 for major surgical acts (70.4%), and 69 for advanced surgical acts (9. 4%). A total of 127 patients had a history of prior laparotomy (17%). All those procedures were performed by young senior surgeons. We defined a complication as an event that had modified the usual course of the procedure or of the postoperative period. For statistical analysis, we used the chi-squared test or Fisher's exact test. RESULTS: Complications occurred in 22 cases; the overall complication rate was 2.9% when all events were considered. One complication (injury of the left primitive iliac artery) was related to insertion of the Veress needle (0.13%). A total of 2,578 trocars were inserted, giving rise to 10 complications (1.3%). Three unintended laparotomies were required for bowel or bladder injuries (0.4%). Finally, the introduction of the laparoscope was responsible for 11 complications (1.4%); this figure represents 50% of all the complications of this series. Eight intraoperative complications (1%) occurred during the laparoscopic surgery (seven severe bleedings and one ureter injury, but no intestinal lesions); laparotomy was required in six of these cases. Three complications occurred during the postoperative stage: one granulomatous peritonitis after intraabdominal rupture of a dermoid cyst, one incisional hernia, and a fast-resolving cardiac arrhythmia. CONCLUSIONS: In our experience, operative gynecological laparoscopy is associated with an acceptable morbidity rate. Moreover, about half of the complications occur during the installation of the laparoscopic procedure, underscoring the usefulness of safety rules.

Asunto(s)

RESUMEN

OBJECTIVES: To compare the effectiveness of single-dose methotrexate (MTX) and laparoscopic salpingostomy in the treatment of unruptured ectopic pregnancy (UEP). METHODS: 75 patients entered a prospective non-randomized study. Thirty-seven women were submitted to a single-dose methotrexate (Group 1) and 38 underwent laparoscopic salpingostomy (Group 2). Methotrexate (1 mg/kg) was given intramuscularly on an out-patient basis if the beta-hCG level was < 5000 IU/I and the hematosalpinx diameter was < 3 cm and the peritoneal fluid < 300 cm3 on TVS. The follow-up consisted of serial clinical examinations, beta-hCG assays, liver tests and blood cell counts. Laparoscopic salpingostomy was decided in other cases of UEP or when patients refused or could not comply with the follow-up. RESULTS: Group 1 patients (91.8%) were cured with 1-3 doses of MTX, the remainder required a laparoscopy. Seventy-three percent of them were treated on an out-patient basis. The mean time to resolution of hCG was 26.7 days. The initial beta-hCG level significantly correlated with the necessity of a surgical option and the time to resolution of beta-hCG. Whenever beta-hCG was < 3600 IU/l, all patients were cured with a single injection, without hospitalization and with a follow-up of < 27 days. Group 2 patients (81.6%) were cured with laparoscopy and 15.8% required a MTX injection for persistent EP. The mean hospital stay was significantly longer than for those that required the MTX injection (2.7 vs. 0.6; P = 0.0001), but the follow-up was shorter and required significantly less clinical examinations, sonograms and biologic tests. Finally the effectiveness of single-dose MTX and laparoscopic salpingostomy were similar (P = 0.2, 95% CI of the difference: -0.15-0.04). CONCLUSIONS: Single-dose MTX was as effective as laparoscopy in the treatment of UEP. A rigorous selection of the patients for the treatment option is mandatory to guarantee high success rates, in an out-patient basis and a short follow-up.

Asunto(s)

RESUMEN

The aim of this study was to compare direct and indirect costs of single-dose methotrexate and laparoscopy in the treatment of unruptured ectopic pregnancy. We conducted a prospective study between 1 January 1995 and 31 May 1997 and recorded costs accrued from outpatient and inpatient treatment with methotrexate (group I) and laparoscopy (group II). We used the French National Social Security nomenclature as reference for the different costs. Indirect costs were estimated from national demographic data. 39 patients were included in group I and 38 in group II. Single-dose methotrexate was the most economic management of unruptured tubal pregnancy ($US1436 per case vs $US3170 per case for laparoscopy) since it reduced the total cost by approximately 50%. This was due to a dramatic reduction in charges related to hospitalisation and the operating room. Indirect costs were also reduced, mainly as a result of a shorter recovery time ($US237 vs $US475). However, there was no further evidence of any cost effectiveness of methotrexate therapy when hospitalisation was required. In conclusion, single-dose methotrexate appeared to be the most economic approach for the treatment of unruptured ectopic pregnancy. Selection of cases is mandatory to guarantee a cost savings for the treatment of unruptured ectopic pregnancy.

Asunto(s)