Estrogen-lowering medical treatment after laparoscopic surgery for symptomatic endometriosis stage iii-iv : is it of value?

Abstract EN

Background / Aim : in order to decrease endometriosis recurrence after surgical therapy, it has been proposed to use a post-surgical estrogen-lowering medical treatment.

The aim of the present study was to evaluate the efficacy of a post-operative regimen of GnRH analogue and danazol in women underwent laparoscopic conservative surgery for endometriosis stage III-IV.

This was studied in a randomized trial in which no post-surgical therapy was compared with a protocol consisting of a 3 months of GnRH analogue and danazol.

The primary objective was to assess whether this surgical / medical combined approach could produce a significantly longer relief of pain symptoms.

The between-group differences in both objective disease recurrence and pregnancy rates among women wanting children were also evaluated.

Patients and Methods : all patients conservatively operated at laparoscopy for stage III-IV endometriosis from March 2004 to May 2006 were requested to enter the study.

Patients who underwent surgery for recurrent endometriosis were excluded from the study, as well as patients who had taken hormonal therapies before laparoscopy.

A total of 134 women were randomized, by computer-generated list, after laparoscopic conservative surgery for symptomatic endometriosis stage III-IV to three groups : Group I (n = 44): receive monthly i.

m.

injections of gonadotropin-releasing hormone (GnRH) analogue, leuprolide acetate depot (3.75 mg) for 3 months.

Group II (n = 45): Postoperative treatment with danazol 600 mg daily for 3 months.

Group III (n = 45) : Subjected to an expectant management.

All patients were regularly followed up every 3 months for at least one year for evaluation of pain symptoms, fertility and objective disease recurrence.

Results : During the follow-up period, which lasts for at least 12 months, five (35.7 %) of the 14 women who wanted children and who were allocated the GnRH analogue, five (33.3 %) of the 15 women in the danazol group, and six (40%) of the 15 given no treatment became pregnant (not significant).

Moderate/severe pelvic pain recurred during the follow-up in 10 (23 %) of the 44 women with pelvic pain allocated the GnRH analogue, 10 (22.2 %) of the 45 women given postoperative danazol, and 11 (24%) of the 45 allocated no treatment.

Four women (9 %) treated with GnRH analogue, five (11 %) allocated to danazol treatment and four (9 %) who received no treatment had objective disease recurrence as demonstrated by gynecological examination and / or pelvic ultrasonography (not significant).

Conclusion : this study does not support the routine post-operative use of a 3 month course of GnRH analogue or danazol after laparoscopic surgery for stage III-IV endometriosis with respect to postoperative expectant management.