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 χ2 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.
RCT Entities:
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 χ2 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.
Authors: Magdalena Bofill Rodriguez; Sofia Dias; Vanessa Jordan; Anne Lethaby; Sarah F Lensen; Michelle R Wise; Jack Wilkinson; Julie Brown; Cindy Farquhar Journal: Cochrane Database Syst Rev Date: 2022-05-31