European journal of obstetrics & gynecology and reproductive biology: X · 2026
Twelve-month pelvic pain after ovarian-preserving laparoscopic hysterectomy: Secondary analysis of a randomized trial of hyaluronic acid gel.
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Hashemi Maryam, Radmanesh Fatemeh, Rouholamin Safoura, Elhaie Mohammadreza
Аннотация
BACKGROUND: Postoperative pelvic pain is a clinically relevant outcome after laparoscopic hysterectomy with ovarian preservation. Hyaluronic acid barriers can reduce postoperative adhesion formation, but whether this translates into lower long-term patient-reported pelvic pain remains uncertain.
METHODS: This secondary analysis of a patient- and outcome-assessor-blinded randomized controlled trial included 180 women undergoing total laparoscopic hysterectomy with preservation of one or both ovaries for benign indications. Participants were randomized 1:1 to receive intraoperative hyaluronic acid gel or no barrier. The primary outcome evaluated in this secondary analysis was patient-reported pelvic pain at 12 months using the Numerical Rating Scale (NRS). Analgesic use, postoperative complications, cystic lesions, and exploratory sonographic findings suggestive of adhesions were also evaluated. Multivariable logistic regression was treated as exploratory.
RESULTS: All participants completed 12-month pain follow-up. Median pain scores were 0 [IQR, 0-2] with gel and 2 [IQR, 0-4] without gel (P < 0.001). Pain (NRS ≥1) was reported by 44/90 (48.9%) participants in the gel group versus 66/90 (73.3%) in the control group, corresponding to an absolute risk difference of -24.4 %age points (95% CI, -38.2 to -10.7) and a relative risk of 0.67 (95% CI, 0.52-0.85). Analgesic use was lower with gel: 25.6% versus 47.8% (P = 0.003). Exploratory sonographic findings suggestive of adhesions and cystic lesions were less frequent in the gel group.
CONCLUSION: In this secondary analysis, intraoperative hyaluronic acid gel application was associated with lower patient-reported pelvic pain at 12 months after ovarian-preserving laparoscopic hysterectomy. Because the parent trial was not powered specifically for long-term pain and baseline pain trajectories were not prospectively quantified, these findings should be considered hypothesis-generating and require confirmation in larger multicentre trials with prospectively specified patient-reported outcomes.
METHODS: This secondary analysis of a patient- and outcome-assessor-blinded randomized controlled trial included 180 women undergoing total laparoscopic hysterectomy with preservation of one or both ovaries for benign indications. Participants were randomized 1:1 to receive intraoperative hyaluronic acid gel or no barrier. The primary outcome evaluated in this secondary analysis was patient-reported pelvic pain at 12 months using the Numerical Rating Scale (NRS). Analgesic use, postoperative complications, cystic lesions, and exploratory sonographic findings suggestive of adhesions were also evaluated. Multivariable logistic regression was treated as exploratory.
RESULTS: All participants completed 12-month pain follow-up. Median pain scores were 0 [IQR, 0-2] with gel and 2 [IQR, 0-4] without gel (P < 0.001). Pain (NRS ≥1) was reported by 44/90 (48.9%) participants in the gel group versus 66/90 (73.3%) in the control group, corresponding to an absolute risk difference of -24.4 %age points (95% CI, -38.2 to -10.7) and a relative risk of 0.67 (95% CI, 0.52-0.85). Analgesic use was lower with gel: 25.6% versus 47.8% (P = 0.003). Exploratory sonographic findings suggestive of adhesions and cystic lesions were less frequent in the gel group.
CONCLUSION: In this secondary analysis, intraoperative hyaluronic acid gel application was associated with lower patient-reported pelvic pain at 12 months after ovarian-preserving laparoscopic hysterectomy. Because the parent trial was not powered specifically for long-term pain and baseline pain trajectories were not prospectively quantified, these findings should be considered hypothesis-generating and require confirmation in larger multicentre trials with prospectively specified patient-reported outcomes.