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

Sponsor
Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04894032
Collaborator
(none)
20
1
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
Actual Study Start Date :
Jan 6, 2021
Anticipated Primary Completion Date :
Jan 6, 2022
Anticipated Study Completion Date :
Jan 6, 2022

Outcome Measures

Primary Outcome Measures

  1. recurrent rate after a meshless method in pelvic prolapse surgery [Through study completion, an average of 6 months]

    Combination of Laparoskopic Uterosacral Ligament and Round Ligament plication

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 85 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zeynep Kamil Maternity and Childrens Training and Research Hospital Istanbul Turkey 34668

Sponsors and Collaborators

  • Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Seren Karakus, Specialist, Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04894032
Other Study ID Numbers:
  • 9/2021
First Posted:
May 20, 2021
Last Update Posted:
May 20, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2021