Marcello Ceccaroni1, Roberto Clarizia1, Stefano Liverani2, Agnese Donati3, Matteo Ceccarello1, Maria Manzone1, Giovanni Roviglione1, Simone Ferrero4. 1. Department of Obstetrics & Gynecology, Gynecologic Oncology and Minimally Invasive Pelvic Surgery, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy. 2. Department of Women's and Children's Health, Gynecology and Obstetrics Clinic, University of Padua, Padova, Italy. 3. Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milano, Italy. 4. Ospedale Policlinico San Martino, Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genoa, Italy.
Abstract
BACKGROUND: The recurrence of deep infiltrating endometriosis (DIE) after its surgical excision is a big problem: postoperative treatment is crucial. OBJECTIVE: To compare two postoperative treatments: Dienogest and GnRH agonists. DESIGN: Prospective Randomized Controlled Trial (RCT). PATIENTS: 146 women submitted to laparoscopic eradication of DIE with bowel and parametrial surgery. INTERVENTIONS: Patients were randomized into two groups. Group A (n = 81) received Triptorelin or Leuprorelin 3.75 mg every 4 weeks for 6 months. Group B (n = 65) received Dienogest 2 mg/day for at least 6 months. A first interview made after six months valued compliance to therapy, treatment tolerability, pain improvement, and side effects. A second interview at 30 ± 6 months valued pain relapse, imaging relapse, and pregnancy rate. MAIN OUTCOMES: The primary outcome was to demonstrate the non-inferiority of Dienogest about the reduction in pain recurrence. Secondary outcomes were differences in terms of treatment tolerability, side effects, imaging relapse rate, and pregnancy rate. RESULTS: Both Dienogest and GnRH agonists were associated with a highly significant reduction of pain at 6 and 30 months, without any significant difference (p < .001). About treatment tolerability, a more satisfactory profile was reported with Dienogest (p = .026). No difference in terms of clinical relapse, imaging relapse, and live births was found. CONCLUSIONS: Dienogest has proven to be as effective as GnRH agonists in preventing recurrence of DIE and associated pelvic pain after surgery. Also, it is better tolerated by patients.
BACKGROUND: The recurrence of deep infiltrating endometriosis (DIE) after its surgical excision is a big problem: postoperative treatment is crucial. OBJECTIVE: To compare two postoperative treatments: Dienogest and GnRH agonists. DESIGN: Prospective Randomized Controlled Trial (RCT). PATIENTS: 146 women submitted to laparoscopic eradication of DIE with bowel and parametrial surgery. INTERVENTIONS: Patients were randomized into two groups. Group A (n = 81) received Triptorelin or Leuprorelin 3.75 mg every 4 weeks for 6 months. Group B (n = 65) received Dienogest 2 mg/day for at least 6 months. A first interview made after six months valued compliance to therapy, treatment tolerability, pain improvement, and side effects. A second interview at 30 ± 6 months valued pain relapse, imaging relapse, and pregnancy rate. MAIN OUTCOMES: The primary outcome was to demonstrate the non-inferiority of Dienogest about the reduction in pain recurrence. Secondary outcomes were differences in terms of treatment tolerability, side effects, imaging relapse rate, and pregnancy rate. RESULTS: Both Dienogest and GnRH agonists were associated with a highly significant reduction of pain at 6 and 30 months, without any significant difference (p < .001). About treatment tolerability, a more satisfactory profile was reported with Dienogest (p = .026). No difference in terms of clinical relapse, imaging relapse, and live births was found. CONCLUSIONS: Dienogest has proven to be as effective as GnRH agonists in preventing recurrence of DIE and associated pelvic pain after surgery. Also, it is better tolerated by patients.
Entities:
Keywords:
Dienogest; Endometriosis; deep infiltrating endometriosis