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Clinical Trials/NCT04894032
NCT04894032
Unknown
Not Applicable

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

Zeynep Kamil Maternity and Pediatric Research and Training Hospital1 site in 1 country20 target enrollmentStarted: January 6, 2021Last updated:

Overview

Phase
Not Applicable
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Enrollment
20
Locations
1
Primary Endpoint
recurrent rate after a meshless method in pelvic prolapse surgery

Overview

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 85 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

recurrent rate after a meshless method in pelvic prolapse surgery

Time Frame: Through study completion, an average of 6 months

Combination of Laparoskopic Uterosacral Ligament and Round Ligament plication

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sultan Seren Karakus

Specialist

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study Sites (1)

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