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Study uniquely powered to compare adverse effects
About 13% of US women will have pelvic organ prolapse (POP) during their lifetimes and undergo surgery for it—with or without hysterectomy. In recent years, as incidence of POP has increased, repairs with uterus-sparing procedures such as vaginal hysteropexy have become more common.
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A new study by Cleveland Clinic researchers of POP repair shows that risk of adverse events (AEs) is lower, operating times and lengths of stay are shorter, and patients lose less blood with hysteropexy alone. The retrospective analysis is the first to be powered specifically for a comparison of AEs between hysteropexy and concurrent hysterectomy for POP as the primary outcome.
“Women who underwent hysterectomy at the time of their prolapse surgery had four-fold higher odds of experiencing any perioperative AE, compared to those who underwent hysteropexy,” says first author Angela S. Yuan, MD, a Fellow in Pelvic Medicine and Reconstructive Surgery. “Our study confirms previous literature and surgeons should factor the data into their counseling of patients with POP who are weighing their options.”
To compare incidence of perioperative AEs associated with POP repair, the authors performed a retrospective matched cohort study. Electronic medical records were used to identify women who had undergone sacrospinous or uterosacral hysteropexy or colpopexy with hysterectomy at Cleveland Clinic between 2012 and 2019. The patients in the cohorts—130 hysteropexy and 260 concurrent hysterectomy—were matched by surgeon, surgical year, and age. Mean age and body mass index were 58 years (±13 years) and 27.9 kg/m2 (±6 kg/m2), respectively.
“This study is unique in that it had a large sample size and was powered for the primary outcome,” says Dr. Yuan. “Although it was retrospective, the procedures all were done in a fairy uniform way and we tried to minimize selection bias with careful matching of the cohorts.”
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In addition, strict definitions were used for all clinically relevant AEs, including urinary tract infection, surgical site infection, intraoperative ureteral kinking, postoperative ureteral injury, neurologic injury, and postoperative urinary retention. To control for confounding, the authors performed multivariable logistic regression, which showed that concomitant hysterectomy at the time of colpopexy was a significant predictor of perioperative AEs.
Compared with the patients who underwent hysteropexy alone, those who had concurrent hysterectomy had significantly longer surgeries (median 145 minutes [range, 74-419 minutes] vs 96 minutes [range, 42-207 minutes], P<0.0001). They also had greater estimated blood loss: median 150 vs 50 mL, P<0.0001).
Looking at AEs, the authors found a higher incidence of any perioperative AEs in the cohort that had undergone hysterectomy (29.0% vs 10.5%, P=0.02). Incidence of intraoperative complications also was higher (10.8% vs 2.3%, P=0.003).
Even after adjustment for age, American Society of Anesthesiologists class, estimated blood loss, operative time, and concurrent nonprolapse procedures, concurrent hysterectomy was still a significant predictor of experiencing any AE (adjusted odds ratio 4.03 [95% confidence interval 1.48-11.01], P=0.007).
Overall, the incidence of AEs was 10.5% for the hysteropexy cohort vs 29.0% for the concurrent hysterectomy cohort. There was no difference in Dindo grade 3 complications between the two cohorts (0.8% vs 1.3%, P=0.12).
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The authors also performed a subanalysis of sacrospinous and uterosacral hysteropexy and found no significant differences in AEs between the two procedures. Operative time was significantly shorter with a sacrospinous procedure (median 89 minutes; range, 42-207 minutes compared with 104 minutes; range, 47-150 minutes, P=0.04).
In terms of hospital stays, the researchers noted that they were longer for the hysterectomy cohort than for the hysteropexy cohort (>1 day hospital stay incidence 14.2% vs 6.9%, P=0.03).
“The uterus does not play an active role in POP. Damage to the supportive ligaments that hold it in place often is what causes the condition,” says Dr. Yuan. “Patients should be told that as part of shared decision-making about repair. Hysterectomy is major surgery and a woman’s preference about whether to retain her uterus needs to be considered.”
Future directions for research at Cleveland Clinic about POP include looking at longer-term outcomes with uterine-preserving surgery, the role of uterine preservation in younger women with the condition, and obstetric outcomes in those who become pregnant after undergoing surgical repair. Cecile Ferrando, MD, MPH, a specialist in female pelvic medicine and reconstructive surgery at Cleveland Clinic and co-author of the study, says “Interest in uterine-sparing surgery is increasing and our division does a large number of hysteropexies each year. This study shows that it is a safe procedure with a low rate of perioperative complications and we will continue to pursue data on longer-term outcomes.”
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