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Thermal balloon ablation versus laparoscopic supracervical hysterectomy for the surgical treatment of heavy menstrual bleeding: A randomized study
Author(s) -
Sesti Francesco,
Ruggeri Velia,
Pietropolli Adalgisa,
Piancatelli Raffaella,
Piccione Emilio
Publication year - 2011
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/j.1447-0756.2011.01596.x
Subject(s) - medicine , endometrial ablation , hysterectomy , amenorrhea , randomization , quality of life (healthcare) , exact test , visual analogue scale , balloon , surgery , randomized controlled trial , blood loss , menstrual bleeding , obstetrics , pregnancy , nursing , biology , genetics
Aim: To compare postoperative outcomes and effects on quality of life following thermal balloon ablation (TBA) or laparoscopic supracervical hysterectomy (LSH) in women with heavy menstrual bleeding (HMB). Material and Methods: Sixty‐eight women requiring surgical treatment for HMB were randomly allocated into two treatment arms: TBA ( n = 34) and LSH ( n = 34). The randomization procedure was based on a computer‐generated list. The primary outcome was a comparison of the effects on menstrual bleeding (Pictorial Blood Loss Assessment Chart [PBAC]) between the two procedures. The secondary outcome measures were quality of life, improvement of bleeding patterns, intensity of postoperative pain, and early postoperative complications. Continuous outcome variables were analyzed using Student's t ‐test. Discrete variables were analyzed with the χ 2 test or Fisher's exact test. P < 0.05 was considered statistically significant. Results: The PBAC score was significantly reduced in both treatment groups. After LSH all women had amenorrhea. After TBA there was a significant improvement of bleeding frequency and length. The postoperative pain intensity at 24 h was significantly minor in women treated with TBA rather than with LSH. The Medical Outcomes Survey Short Form 36 (SF‐36) score improved in both groups. However, LSH showed a negative impact on the emotional state. No intraoperative complications occurred, and no case was returned to the theatre in either group. Conclusion: The effectiveness of TBA as a possible treatment of HMB is confirmed. However, LSH showed a definitive improvement of the symptoms, and a better life quality profile. Further controlled prospective studies are required for identifying the best surgical approach in women with HMB.