Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
total laparoscopic hysterectomy with sacrocolpopexy
total laparoscopic hysterectomy with lateral suspension
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring lateral suspension, laparoscopic hysterectomy, pelvic organ prolapse, sacrocolpopexy
Eligibility Criteria
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
Sites / Locations
- Antalya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TLHS
TLHLS
Arm Description
total laparoscopic hysterectomy with sacrocolpopexy will be performed
total laparoscopic hysterectomy with lateral suspension will be performed
Outcomes
Primary Outcome Measures
Rate of objective cure
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
Secondary Outcome Measures
Patient Global Impression of Improvement (PGI-I)
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."
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
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.
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
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.
Full Information
NCT ID
NCT03722563
First Posted
October 25, 2018
Last Updated
February 10, 2021
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03722563
Brief Title
Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse
Official Title
Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
lateral suspension, laparoscopic hysterectomy, pelvic organ prolapse, sacrocolpopexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TLHS
Arm Type
Active Comparator
Arm Description
total laparoscopic hysterectomy with sacrocolpopexy will be performed
Arm Title
TLHLS
Arm Type
Experimental
Arm Description
total laparoscopic hysterectomy with lateral suspension will be performed
Intervention Type
Procedure
Intervention Name(s)
total laparoscopic hysterectomy with sacrocolpopexy
Intervention Description
Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
Intervention Type
Procedure
Intervention Name(s)
total laparoscopic hysterectomy with lateral suspension
Intervention Description
Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
Primary Outcome Measure Information:
Title
Rate of objective cure
Description
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient Global Impression of Improvement (PGI-I)
Description
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."
Time Frame
12 months
Title
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
Description
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.
Time Frame
12 months
Title
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bekir Sıtkı İsenlik, MD
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital
City
Antalya
State/Province
Muratpaşa
ZIP/Postal Code
07230
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse
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