Comparison of Post-operative Symptoms After Two Surgeries for Patients With Pelvic Organ Prolapse

NCT05697796 | Completed

• 1 other identifier: PKUPH8
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• changes in POP-Q score at different time nodes

  Gynecological examination

  pre-operation and post-operation(1month, 3 months and 6 months )

Secondary Outcomes (3)

• UDI-6 scores at different time nodes

  pre-operation and post-operation(1month, 3 months and 6 months )

• PFDI-20 scores at different time nodes

  pre-operation and post-operation(1month, 3 months and 6 months )

• OABss scores at different time nodes

  pre-operation and post-operation(1month, 3 months and 6 months )

Study Arms (2)

patients had pelvic organ prolapse who undergone Sacrospinal ligament fixation

Procedure: Two different surgical methods

patients had pelvic organ prolapse who undergone Extraperitoneal high sacral ligament suspension

Procedure: Two different surgical methods

Interventions

Two different surgical methods PROCEDURE

SSLF：sacrospinal ligament fixation EHUS：Extraperitoneal high sacral ligament suspension

patients had pelvic organ prolapse who undergone Extraperitoneal high sacral ligament suspension; patients had pelvic organ prolapse who undergone Sacrospinal ligament fixation

Eligibility Criteria

• Age: 30 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients had pelvic organ prolapse receiving two specific surgical methods

You may qualify if:

• Age ≥ 30 years;
• Because pelvic organ prolapse in our hospital, we performed extraperitoneal high sacral ligament suspension or sacrospinal ligament fixation; ③ Those who have no surgical contraindication and can tolerate surgery and anesthesia.

You may not qualify if:

• Those who cannot tolerate surgery and anesthesia; ② Patients receiving other tip suspension techniques.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

The Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director, professor

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 26, 2023
• Study Start: November 1, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: January 26, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)