NCT04894032

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2022

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

April 5, 2021

Last Update Submit

May 14, 2021

Conditions

Pelvic Organ ProlapseProlapse UterusProlapse Bladder

Outcome Measures

Primary Outcomes (1)

  • recurrent rate after a meshless method in pelvic prolapse surgery

    Combination of Laparoskopic Uterosacral Ligament and Round Ligament plication

    Through study completion, an average of 6 months

Interventions

Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.PROCEDURE

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

Eligibility Criteria

Age30 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients age between 30 to 85
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Fmale patients 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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have a gynecological malignancy
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Childrens Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pelvic Organ ProlapseUterine Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Sultan Seren Karakuş, MD

CONTACT

00905355660095serensultan@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

April 5, 2021

First Posted

May 20, 2021

Study Start

January 6, 2021

Primary Completion

January 6, 2022

Study Completion

January 6, 2022

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)