Combination of Laparoskopic Uterosacral Ligament and Round Ligament Plication, A Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse.

NCT ID: NCT04894032

Last Updated: 2021-05-20

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2022-01-06

Brief Summary

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Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.

Detailed Description

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Following the approval of the ethics committee, Female patients admitted to Urogynecology and Gynecology Outpatient Clinic of Zeynep Kamil Gynecology and Child Diseases Education and Research Hospital with the complaint of prolapse of the genital organs, who do not respond or not willing to take conservative treatment and have Stage 2 or higher pelvic organ prolapse according to POP-Q staging system and who have completed the fertility period will be included in our study. Patients Age, gravida and parity of the patients, menopausal status, whether she is hysterectomized, the stage of prolapse according to POP-Q and other gynecological examination findings will be recorded.Patients will be asked about preoperative urinary system pathologies (voiding dysfunction, urinary incontinence, recurrent UTI) and Urodynamic examination will be done accordingly.

Prolapsus and its Impact on the quality of life will be recorded preoperatively with quality of life questionnaires.At the early postoperative period and preoperatively, the duration of the operation, blood loss during the surgery, VAS score , and the presence of complications will be recorded. Patients will be called postoperatively for control examination at the 1st month , 6th month , 1st year and subsequently annual control will be done.Objective success; Stage 1 according to POP-Q or no prolapse. Subjective success will be accepted once the patient has no prolapse-related complaints.In the postoperative period, whether there is any change in urinary system and sexual functions will be questioned with the help of questionnaires.Laparoscopic Uterosacral Ligament plication, fixation of PVC fascia and the combination with round ligament plication will be evaluated in terms of efficacy and reliability.

Conditions

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Pelvic Organ Prolapse Prolapse Uterus Prolapse Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.

Laparoscopic Uterosacral Ligament Plication, Fixation of PVC fascia and the combination with round ligament plication

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female patients age between 30 to 85
* Having Stage 2 or higher pelvic organ prolapse according to POP-Q staging system
* Patients who accept the surgical treatment

Exclusion Criteria

* Patients who have a gynecological malignancy
* Pregnant patients
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sultan Seren Karakus

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zeynep Kamil Maternity and Childrens Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sultan Seren Karakuş, MD

Role: CONTACT

00905355660095

Facility Contacts

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Sultan Seren Karakus, MD

Role: primary

00905355660095

Other Identifiers

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9/2021

Identifier Type: -

Identifier Source: org_study_id

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