Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries
Primary Purpose
Patients With Pelvic Organ Prolapse, Pectopexy, Lateral Suspension
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pectopexy
lateral suspension
Sponsored by
About this trial
This is an interventional screening trial for Patients With Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria: Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse, Being a Citizen of the Republic of Turkey over the age of 18 Patients operated by the same experienced surgeons Exclusion Criteria: To have received chemotherapy and/or radiotherapy for any reason before Having previously operated for prolapse Cases with Contraindications for Laparoscopy Cases with severe cardiovascular or respiratory disease
Sites / Locations
- Gaziosmanpasa Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with pelvic organ prolapse undergone pectopexy surgery
Patients with pelvic organ prolapse undergone lateral suspension surgery
Arm Description
Outcomes
Primary Outcome Measures
Comparison of pre and post operative assessment of POP-Q measurements
Comparison of POP-Q values of patients undergone pectopexy and lateral suspension pre and postoperatively.
Comparison of Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire will be compared before and after surgery. PISQ- 12 is a Likert type of survey with five options (scoring from 0 to 4) in each question and the patient is asked a total of 12 questions. The total score is calculated by summing points given to each question. A higher score means better sexual function and the highest total score is 48.
Secondary Outcome Measures
Full Information
NCT ID
NCT05930795
First Posted
June 2, 2023
Last Updated
June 29, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05930795
Brief Title
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries
Official Title
Evaluation of the Comparison of Anatomical and Functional Results of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries for the Treatment of Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
September 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (LLS) surgeries in the surgical treatment of pelvic organ prolapse. However, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. For example,In a study, the clinical and anatomical success rate in LLS operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.In another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.
Detailed Description
Pelvic organ prolapse (POP) can be defined as the protrusion of the pelvic organs out of the vagina. Many women experience the symptoms of prolapse of the pelvic organs during their daily activities, during sexual intercourse or during exercise. POP causes various undesirable effects in terms of sexual life and body aesthetics in women. With the increase in the number of elderly individuals in societies, the prevalence of prolapse cases is increasing and is becoming more common.
Patients who had laparoscopic pectopexy operation due to minimum POPQ stage 2 according to the International Classification of Pelvic Organ Prolapse Quantification (POP Q) in our hospital and who had ls lateral suspension surgery with the same indication were planned to be included retrospectively. In the first group, patients who had laparoscopic pectopexy operation were planned to be included. In the second group, it was planned to include patients who had ls lateral suspension operation.
Demographic and intra operative data collected before the procedure: (operation time, estimated blood loss, hospital stay, bowel and bladder injury) and intra operative and postoperative complications and recurrence rates and anatomically preoperative and post op Pelvic prolapse (with POP-Q classification), PopQ values (minimum 6 months) were aimed to be compared between two groups to assess anatomic comparement. Furthermore, the patients will be called back and Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PİS-Q) questionnaire will be applied to both groups and the results will be compared prospectively to assess functional results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Pelvic Organ Prolapse, Pectopexy, Lateral Suspension, Pop-q, Pisq-12
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with pelvic organ prolapse undergone pectopexy surgery
Arm Type
Active Comparator
Arm Title
Patients with pelvic organ prolapse undergone lateral suspension surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
pectopexy
Other Intervention Name(s)
surgery performed by suspending prolapsed uterus or vault to the pectineal ligament
Intervention Description
pectopexy: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament
Intervention Type
Procedure
Intervention Name(s)
lateral suspension
Intervention Description
lateral suspension: surgery performed by suspending prolapsed uterus or vault to the lateral walls of the abdomen corresponding to the 3 cm anterior superior to the iliac crest
Primary Outcome Measure Information:
Title
Comparison of pre and post operative assessment of POP-Q measurements
Description
Comparison of POP-Q values of patients undergone pectopexy and lateral suspension pre and postoperatively.
Time Frame
1 year
Title
Comparison of Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire
Description
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire will be compared before and after surgery. PISQ- 12 is a Likert type of survey with five options (scoring from 0 to 4) in each question and the patient is asked a total of 12 questions. The total score is calculated by summing points given to each question. A higher score means better sexual function and the highest total score is 48.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse,
Being a Citizen of the Republic of Turkey over the age of 18
Patients operated by the same experienced surgeons
Exclusion Criteria:
To have received chemotherapy and/or radiotherapy for any reason before
Having previously operated for prolapse
Cases with Contraindications for Laparoscopy
Cases with severe cardiovascular or respiratory disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serkan Kumbasar, MD
Phone
+905067873216
Email
doktor1977@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Ketenci Gencer, MD
Phone
05416116469
Email
fathma_k@hotmail.com
Facility Information:
Facility Name
Gaziosmanpasa Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serkan Kumbasar, MD
Phone
+905067873216
First Name & Middle Initial & Last Name & Degree
Fatma Ketenci Gencer, MD
Phone
+905416116469
Email
fathma_k@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries
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