Hysteropexy, Uterovaginal Prolapse
Conditions
Brief summary
* objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse * prospective randomized clinical trial * patient 1. 60yrs or more women and 2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom * number of patient: 146 * randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy * follow up: postoperative 1 year * primary endpoint: recurrence rate 1. recurrence of uterovaginal prolapse POP-Q stage II-IV 2. recurrence of associated symptom * secondary endpoint 1. postoperative 1 year QOL, degree of satisfaction evaluation 2. operative time, estimated blood loss 3. hospitalization period, postoperative pain, return to normal activity
Interventions
PROCEDUREpatient who undergo laparoscopic/robotic-assisted hysteropexy
PROCEDUREpatient who undergo vaginal hysterectomy
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
Exclusion criteria
* abnormal uterine bleeding * significantly enlarged fibroid uterus * postmenopausal uterine bleeding * endometrial pathology * on tamexifen * concomitant medical problems precluding general anesthesia or surgery * damaged agreement ability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence rate (%) | postoperative 1 year | recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year |
Countries
South Korea
Contacts
Primary ContactDong Hun Suh, associate professor
Outcome results
None listed