- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722563
Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse
February 10, 2021 updated by: bekirsitkiisenlik, Antalya Training and Research Hospital
Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial
This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Muratpaşa
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Antalya, Muratpaşa, Turkey, 07230
- Antalya Training And Research Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management
Exclusion Criteria:
- Patients that are not candidates for general anesthesia or laparoscopy
- Inability to consent
- history of hysterectomy
- history of anterior or apical pelvic organ prolapse surgery
- history of urinary incontinence surgery
- pregnancy or breast-feeding during the study period
- suspicious adnexal masses or other factors that may indicate pelvic malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TLHS
total laparoscopic hysterectomy with sacrocolpopexy will be performed
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Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
|
Experimental: TLHLS
total laparoscopic hysterectomy with lateral suspension will be performed
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Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of objective cure
Time Frame: 12 months
|
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Global Impression of Improvement (PGI-I)
Time Frame: 12 months
|
Patient Global Impression of Improvement scale is global index that may be used to rate the response of a condition to a therapy. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse." |
12 months
|
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
Time Frame: 12 months
|
The questionnaire contains four items: frequency of urinary incontinence, amount of leakage, overall impact of urinary incontinence and self-diagnostic.
The first item has 6 response categories (never, once a week, two or three times a week, once a day, a few times a day, always) and is scored from 0 to 5. The second item has 4 response categories (none, small amount, moderate amount, large amount) and is scored 0, 2, 4, or 6.
The third item (how much urine leakage affects your daily life) has 5 response (not at all, mildly, moderately, severely, to a great extent) and is scored from 0 to 10.
The first three items are scored and then summed to produce a total score, ranging from 0 to 21.
The last item is a diagnostic item to assess the perceived cause of incontinence.
This item is included upon the request of clinicians and is not used for scoring.
A higher ICIQ-UI-SF score indicates higher frequency, severity, and lower quality of life.
|
12 months
|
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
Time Frame: 12 months
|
The questionnaire evaluates several pelvic floor dysfunctions including questions regarding intestinal, vaginal, sexual symptoms and quality of life impact.
It includes 14 questions (dragging abdominal pain, vaginal soreness, reduced sensation around vagina, vagina too loose/lax, lump coming down in vagina, lump coming out of vagina, dry vagina, digitation for bowel opening, tight vagina, current sex life, worries about vagina affect sex life, relationship, sex life spoilt, overall impact on everyday life) and divided into three independent domains.
Vaginal symptoms score varies from 0 to 53.
Sexual symptoms score varies from 0 to 58.
Quality of life impact score varies from 0 to 10. Usually each question has 3 to 5 possible answers; the higher the score, the most severe is the symptom or the negative quality of life impact.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bekir Sıtkı İsenlik, MD, Antalya Training And Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2019
Primary Completion (Actual)
January 22, 2021
Study Completion (Actual)
January 22, 2021
Study Registration Dates
First Submitted
October 25, 2018
First Submitted That Met QC Criteria
October 25, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLHSvsTLHLS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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