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This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. Patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. Follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. The primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. We hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic lateral suspension | Experimental |
| |
| transvaginal sacrospinous ligament fixation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic lateral suspension | Procedure | Laparoscopic lateral suspension: Place a 1/2 T4 mesh in the vesicovaginal space. The two lateral slings are passed out from the outer upper side of the bilateral anterior superior iliac spine, and the prolapsed organs are suspended to the abdominal wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical success rate | Surgical success is defined as follows:
| From enrollment to the end of surgery at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of urinary retention after catheter removal | A residual urine volume greater than 100 ml as measured by ultrasound is considered urinary retention. | From enrollment to the end of surgery at 3 days |
| Differences in the severity of overactive bladder (OAB) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mesh-related complications | The Category-Time-Section (CTS) classification is used to document the location, timing, and type of mesh-related complications. | From enrollment to the end of surgery at 1 year |
| Duration of surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100044 | China |
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|
| Transvaginal sacrospinous ligament fixation | Procedure | Transvaginal sacrospinous ligament fixation: Dissect the rectovaginal space to expose the right sacrospinous ligament, and fix the cervix or vaginal cuff to the right sacrospinous ligament. |
|
It will be assessed by using the Overactive Bladder Symptom Score (OABSS). The score of OABSS ranges from 0 to 15. The higher the score, the more severe the overactive bladder condition is. |
| 1 month, 3 months, 6 months and 1 year post-surgery |
| Differences in the severity of urinary incontinence after surgery | It will be assessed by using the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). The score of ICIQ-SF ranges from 0 to 21. The higher the score, the more severe the urinary incontinence condition is. | 1 month, 3 months, 6 months and 1 year post-surgery |
| Differences in the severity of pelvic floor dysfunction after surgery | It will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20).The score of PFDI-20 ranges from 0 to 300. The higher the score, the more severe the pelvic floor dysfunction is. | 1 month, 3 months, 6 months and 1 year post-surgery |
| Differences in quality of life after surgery | It will be assessed using the Pelvic Floor Impact Questionnaire (PFIQ).The score of PFIQ ranges from 0 to 300. The higher the score, the poorer the patient's quality of life is. | 1 month, 3 months, 6 months and 1 year post-surgery |
| Differences in patients' satisfaction | It will be assessed using the Patient Global Impression of Improvement (PGI-I) questionnaire. The score of PGI-I ranges from 0 to 7. The higher the score, the lower the patient's satisfaction is. | 1 month, 3 months, 6 months and 1 year post-surgery |
| Postoperative Pain | It will be assessed using the Wong-Baker Faces Pain Rating Scale (FPS-R). The score of FPS-R ranges from 0 to 10. The higher the score, the more severe the pain is. | 1 month, 3 months, 6 months and 1 year post-surgery |
We record the duration of surgery (hours) based on the anesthesia record sheet.
| Intraoperative |
| Blood loss | We record the amount of blood loss (ml) based on the anesthesia record sheet. | From enrollment to the end of surgery at 1 year |
| Change in hemoglobin level | Record the difference in hemoglobin concentration before and after surgery (in g/L). | From enrollment to the end of surgery at 1 year |
| Hospital stay duration | The number of days from admission to discharge for the patient (days). | From enrollment to the end of surgery at 1 year |
| Number of patients with surgical complications | If patients experience discomfort during the perioperative period or after surgery, they will be advised to seek medical attention promptly to assess for complications. The severity of complications is evaluated using the Clavien-Dindo classification. | From enrollment to the end of surgery at 1 year |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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