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Transvaginal single-port laparoscopy uterosacral ligament suspension versus conventional laparoscopy uterosacral ligament suspension in uterine prolapse: a prospectiv randomized control and non-inferiority trial

Transvaginal single-port laparoscopy uterosacral ligament suspension versus conventional laparoscopy uterosacral ligament suspension in uterine prolapse: a prospectiv randomized control and non-inferiority trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063408
Enrollment
Unknown
Registered
2022-09-06
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine prolapse

Interventions

vNOTES-HUS:vNOTES uterosacral ligament suspension
cLAP-HUS:cLAP uterosacral ligament suspension

Sponsors

Meizhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Participants must have a diagnosed uterine prolapse of POP stage = 2 according to the POP-Q classification system. (2) This should be their first surgical treatment for POP. (3) Participants must express a desire for preservation of coital function.

Exclusion criteria

Exclusion criteria: (1) Participants who are unable to tolerate surgical treatment. (2) Participants who have severe adhesions suspected during pelvic examination. (3) Participants who are suspected to have gynecological malignancy. (4) Participants who have a current urogenital tract infection. (5) Participants who have had a prior hysterectomy.

Design outcomes

Primary

MeasureTime frame
The success rate of uterine prolapse correction among women after one year of surgery;

Secondary

MeasureTime frame
Intraoperative parameters will include the operation method, operation time, uterus weight, intraoperative complications, changes in hemoglobin level, and operative blood loss.;Postoperative parameters will include postoperative pain scores (measured using the VAS at different time points: immediately after the operation, at 24 hours, and at 48 hours after surgery), defecation time after the surgery, fever (defined as an axillary temperature exceeding 38?), urinary retention, vessel thrombosis, postoperative infection, urinary system injury, changes in postoperative POP-Q stage, length of postoperative hospital stay, and cost of hospitalization.;Follow-up parameters will include the occurrence or recurrence of urinary incontinence, coital pain, recurrence of changes in POP-Q stage at 1 month, 1 year, and 5 years after surgery, scores from the PFIQ-7 at 1 month, 1 year, and 5 years after surgery, and scores from the (PISQ-12) at 1 year and 5 years after surgery.;

Countries

China

Contacts

Public ContactHou Tao

Meizhou People's Hospital

houtao@mzrmyy.com+86 137 1996 5577

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026