Patients With Pelvic Organ ProlapseNCT05930795
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries
A study testing pectopexy and lateral suspension in people with Patients With Pelvic Organ Prolapse and Pectopexy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patients With Pelvic Organ Prolapse, Pectopexy, Lateral Suspension
- What is being tested?
- pectopexy and lateral suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2022to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
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
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.
Read the 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.
- Being tested
- pectopexy, lateral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectopexyProcedure or surgery
Also called surgery performed by suspending prolapsed uterus or vault to the pectineal ligament
pectopexy: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament
lateral suspensionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with pelvic organ prolapse undergone pectopexy surgery | Active comparator | Not described Receives: Procedure: pectopexy |
| Patients with pelvic organ prolapse undergone lateral suspension surgery | Active comparator | Not described Receives: Procedure: lateral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start10 Aug 2022
- Primary completion10 Aug 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Kumbasar, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930795
- Sponsor's protocol ID
- GaziosmanpaşaTREHv
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05930795
- Acronym / sponsor ID
- GaziosmanpaşaTREHv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pelvic organ prolapse undergone pectopexy surgery | Active comparator | Procedure: pectopexy |
| Patients with pelvic organ prolapse undergone lateral suspension surgery | Active comparator | Procedure: lateral suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pectopexyAlso: surgery performed by suspending prolapsed uterus or vault to the pectineal ligamentpectopexy: surgery performed by suspending prolapsed uterus or vault to the pectineal ligament | Procedure or surgery | Patients with pelvic organ prolapse undergone pectopexy surgery |
| lateral suspensionlateral 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 | Procedure or surgery | Patients with pelvic organ prolapse undergone lateral suspension surgery |
Primary outcome
Comparison of pre and post operative assessment of POP-Q measurements
Time frame: 1 year
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
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Patients With Pelvic Organ Prolapse
Active, not recruiting
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
Active, not recruiting
Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP)
RecruitingObservational study
Prospective Observational Prolapse Study
Vaginal Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pectopexy and lateral suspension in people with Patients With Pelvic Organ Prolapse and Pectopexy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pre and post operative assessment of POP-Q measurements (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.