Clinical trial · Observational
POPQ Associated With Total Laparoscopic Hysterectomy
POPQ Associated With Total Laparoscopic Hysterectomy - Multicenter Prospective Observational Study - POP-LAP STUDY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate the impact of different hysterectomy (removal of the uterus) techniques on the risk of pelvic organ prolapse (situation when one or more of your pelvic organs like your bladder, uterus, or rectum have dropped down or slipped out of their normal position, sometimes even bulging into the vagina) and urinary incontinence (leaking urine unexpectedly) in women aged 18-85 who underwent hysterectomy or supracervical hysterectomy (removing of the uterus without its cervix) for benign (not cancer) conditions. The main question is: to check how different surgical technique (laparoscopic, with opening the abdomen, vaginal and robotic) increase the risk of pelvic organ prolapse or urinary incontinence There is no randomization or control group; comparisons will be made between surgery types based on clinical and questionnaire data. Participants will: * Receive an invitation to participate if they underwent hysterectomy between 2021-2025. * Fill out validated quality of life questionnaires (P-QOL, POPDI-6, PFIQ-7) every two years. * Attend follow-up clinical pelvic exams every two years to assess vaginal cuff healing, pelvic organ prolapses (POP-Q system), and urinary symptoms. This prospective, non-commercial, multicenter study plans to enroll 2,000 women and will run from July 1, 2025, to July 1, 2036
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding Unrelated to Menstrual Cycle | — | UNRESOLVED | — |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
| Pelvic Organ Prolapse (POP) | — | UNRESOLVED | — |
| Uterine Fibroids (UF) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire and Physical Exam | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Lap-hyst
- description
- Women who underwent laparoscopic hysterectomy for benign conditions
- interventionNames
- Other: Questionnaire and Physical Exam
- label
- Robot-hyst
- description
- Women who underwent robotic hysterectomy for benign conditions
- interventionNames
- Other: Questionnaire and Physical Exam
- label
- Vaginal-Hyst
- description
- Women who underwent vaginal hysterectomy for benign conditions
- interventionNames
- Other: Questionnaire and Physical Exam
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery * agree to participate and to follow-up Exclusion Criteria: * having uterus * health state - ECOG \>2 * pelvic organ prolapse prior to the surgery * surgery due to malignant conditions (ovarian, cervical or endometrial cancer)
References
Publications (0)
Data not yet available