the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

NCT ID: NCT05189665

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-04-30

Brief Summary

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The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.

Detailed Description

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Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20,ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extraperitoneal high sacral ligament suspension Group

We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them.

Group Type EXPERIMENTAL

Extraperitoneal high sacral ligament suspension surgery

Intervention Type PROCEDURE

The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .

Sacrospinous Ligament Suspension Group

We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them.

Group Type ACTIVE_COMPARATOR

Sacrospinous ligament fixation

Intervention Type PROCEDURE

The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.

Interventions

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Extraperitoneal high sacral ligament suspension surgery

The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .

Intervention Type PROCEDURE

Sacrospinous ligament fixation

The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age ≥30 years old;

pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life

Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery

The patient agrees to conduct the study and can be followed up on time.

Exclusion Criteria

Those who cannot tolerate surgery and anesthesia

Those who need to remove the uterus

Those who have removed the uterus

Those who cannot be followed up on time.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sun Xiuli

Chief Gynecology Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xiuli sun, professor

Role: STUDY_CHAIR

Beijing Key Laboratory of Female Pelvic Floor Disorders

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xiuli sun, professor

Role: CONTACT

010-88324354

Facility Contacts

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xiuli sun, professor

Role: primary

010-88324354

jiaoyang song, doctor

Role: backup

010-88324354

Other Identifiers

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Pkuh4

Identifier Type: -

Identifier Source: org_study_id

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