Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04894032 |
| Other study ID # |
9/2021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2021 |
| Est. completion date |
January 6, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital |
| Contact |
Sultan Seren Karakus, MD |
| Phone |
00905355660095 |
| Email |
serensultan[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ
Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
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.
