Pelvic Organ Prolapse (POP)LLS-HYSNCT07094815
Effectiveness of Laparoscopic Lateral Suspension With or Without Hysterectomy in Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse (POP) and Uterine Prolapse, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of laparoscopic lateral suspension (LLS) with and without hysterectomy in the treatment of pelvic organ prolapse. Pelvic organ prolapse is a condition that affects many women and can significantly reduce quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Uterine Prolapse
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2025to 28 Jun 2025
- Phase
- Observational
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 40 to 80 years who underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy for the treatment of pelvic organ prolapse at SBÜ Gaziosmanpaşa Training and Research Hospital between 2021 and 2024. All patients had at least 12 months of postoperative follow-up, and data were collected retrospectively from medical records.
Who may be able to join
- Female patients aged 40 to 80 years
- Diagnosis of pelvic organ prolapse (POP) requiring surgical management
- Underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy
- Minimum of 12 months postoperative follow-up available
- Ability to provide informed consent for use of medical data in this retrospective study
Who cannot join
- History of connective tissue disorders
- History of prior pelvic reconstructive surgery
- Active pelvic infection or suspected malignancy at the time of surgery
- Severe systemic disease that could significantly affect surgical outcomes
- Incomplete medical records or missing follow-up data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
Istanbul, Istanbul, 34255
About this study
Official title: Comparative Outcomes of Uterus-Preserving and Hysterectomy Approaches in Laparoscopic Lateral Suspension
This study aims to compare the effectiveness of laparoscopic lateral suspension (LLS) with and without hysterectomy in the treatment of pelvic organ prolapse. Pelvic organ prolapse is a condition that affects many women and can significantly reduce quality of life. Laparoscopic lateral suspension is a minimally invasive surgical technique used to correct this condition. In some cases, the uterus is preserved, while in others, hysterectomy is performed at the same time.
The study retrospectively evaluates patients who underwent laparoscopic lateral suspension, either with or without hysterectomy, at SBÜ Gaziosmanpaşa Training and Research Hospital. Medical records were reviewed to collect information about surgery duration, anatomical success (measured by the POP-Q system), complication rates, blood loss, hospital stay, and recurrence rates.
The goal of this study is to determine whether performing a hysterectomy during laparoscopic lateral suspension has a significant effect on surgical outcomes. The findings may help guide surgical decision-making and improve treatment strategies for women with pelvic organ prolapse.
Read the detailed description
This retrospective cohort study was conducted at SBÜ Gaziosmanpaşa Training and Research Hospital to compare the outcomes of laparoscopic lateral suspension (LLS) with and without concomitant hysterectomy in women with pelvic organ prolapse (POP). POP is a prevalent condition that significantly affects quality of life, and LLS is increasingly performed as a minimally invasive approach that allows either uterine preservation or hysterectomy.
A total of 87 patients treated between 2021 and 2024 were analyzed: 43 underwent LLS with total laparoscopic hysterectomy, and 44 underwent uterus-preserving LLS. Preoperative, intraoperative, and postoperative data were collected from electronic medical records, operative reports, and follow-up documentation, with at least 12 months of follow-up. Outcome measures included POP-Q scores, operative time, blood loss, hospital stay, perioperative complications, recurrence, pelvic pain, and urinary incontinence.
The analysis showed that both groups achieved significant anatomical improvement, with no significant differences in recurrence, pelvic pain, or urinary incontinence. However, hysterectomy was associated with longer operative times, increased blood loss, and longer hospital stays. Vaginal length was better preserved in uterus-preserving procedures. No major intraoperative or postoperative complications occurred.
These findings indicate that adding hysterectomy to LLS increases surgical burden without conferring additional anatomical or functional benefit. Uterus-preserving LLS appears to be a safe and effective option in appropriately selected patients, supporting shared decision-making in pelvic reconstructive surgery.
- Conditions
- Pelvic Organ Prolapse (POP), Uterine Prolapse
- Keywords
- Laparoscopic Lateral Suspension, Uterus Preservation, Uterine Prolapse, Pelvic Organ Prolapse, Minimally Invasive Surgery, POP-Q System, Surgical Outcomes, Gynecologic Surgery, Pelvic Floor Disorders
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LLS with Hysterectomy | Patients who underwent laparoscopic lateral suspension combined with total laparoscopic hysterectomy. | |
| Uterus-Preserving LLS | Patients who underwent laparoscopic lateral suspension with uterine preservation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Success Based on POP-Q System
Primary Outcome Title:
Number of Participants Achieving Anatomical Success Based on POP-Q System
Description:
Anatomical success is defined as all assessed POP-Q points (Aa, Ba, C, D, Ap, Bp) being at or above -1 cm (no prolapse extending more than 1 cm below the hymen).
POP-Q scale values: Negative values indicate the point is above the hymen (better anatomy), positive values indicate prolapse below the hymen (worse anatomy).
Typical range: Aa, Ba, Ap, Bp = -3 to +3 cm; C and D vary according to total vaginal length (TVL).
Time Frame:
12 months after surgery
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start28 May 2025
- Primary completion28 Jun 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse (POP)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094815
- Sponsor's protocol ID
- lateralsuspwithuterusornot
- Acronym
- LLS-HYS
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study is based on retrospective medical record review and no consent for data sharing was obtained from participants. All data are stored and analyzed internally according to institutional policies and ethical approvals.
Publications
Kumbasar S, Salman S, Sogut O, K Gencer F, Bacak HB, Tezcan AD, Timur GY. Uterine-sparing laparoscopic lateral suspension in the treatment of pelvic organ prolapse. J Obstet Gynaecol Res. 2023 Jan;49(1):341-349. doi: 10.1111/jog.15459. Epub 2022 Oct 5.
PubMed 36196844
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Uterus-Preserving and Hysterectomy Approaches in Laparoscopic Lateral Suspension
- ClinicalTrials.gov ID
- NCT07094815
- Acronym / sponsor ID
- LLS-HYS / lateralsuspwithuterusornot
- Conditions
- Pelvic Organ Prolapse (POP), Uterine Prolapse
- Keywords
- Laparoscopic Lateral Suspension, Uterus Preservation, Uterine Prolapse, Pelvic Organ Prolapse, Minimally Invasive Surgery, POP-Q System, Surgical Outcomes, Gynecologic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 28 May 2025 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 30 Jul 2025 (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.
This study aims to compare the effectiveness of laparoscopic lateral suspension (LLS) with and without hysterectomy in the treatment of pelvic organ prolapse. Pelvic organ prolapse is a condition that affects many women and can significantly reduce quality of life. Laparoscopic lateral suspension is a minimally invasive surgical technique used to correct this condition. In some cases, the uterus is preserved, while in others, hysterectomy is performed at the same time.
The study retrospectively evaluates patients who underwent laparoscopic lateral suspension, either with or without hysterectomy, at SBÜ Gaziosmanpaşa Training and Research Hospital. Medical records were reviewed to collect information about surgery duration, anatomical success (measured by the POP-Q system), complication rates, blood loss, hospital stay, and recurrence rates.
The goal of this study is to determine whether performing a hysterectomy during laparoscopic lateral suspension has a significant effect on surgical outcomes. The findings may help guide surgical decision-making and improve treatment strategies for women with pelvic organ prolapse.
Detailed description
This retrospective cohort study was conducted at SBÜ Gaziosmanpaşa Training and Research Hospital to compare the outcomes of laparoscopic lateral suspension (LLS) with and without concomitant hysterectomy in women with pelvic organ prolapse (POP). POP is a prevalent condition that significantly affects quality of life, and LLS is increasingly performed as a minimally invasive approach that allows either uterine preservation or hysterectomy.
A total of 87 patients treated between 2021 and 2024 were analyzed: 43 underwent LLS with total laparoscopic hysterectomy, and 44 underwent uterus-preserving LLS. Preoperative, intraoperative, and postoperative data were collected from electronic medical records, operative reports, and follow-up documentation, with at least 12 months of follow-up. Outcome measures included POP-Q scores, operative time, blood loss, hospital stay, perioperative complications, recurrence, pelvic pain, and urinary incontinence.
The analysis showed that both groups achieved significant anatomical improvement, with no significant differences in recurrence, pelvic pain, or urinary incontinence. However, hysterectomy was associated with longer operative times, increased blood loss, and longer hospital stays. Vaginal length was better preserved in uterus-preserving procedures. No major intraoperative or postoperative complications occurred.
These findings indicate that adding hysterectomy to LLS increases surgical burden without conferring additional anatomical or functional benefit. Uterus-preserving LLS appears to be a safe and effective option in appropriately selected patients, supporting shared decision-making in pelvic reconstructive surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLS with Hysterectomy | – | –Patients who underwent laparoscopic lateral suspension combined with total laparoscopic hysterectomy. |
| Uterus-Preserving LLS | – | –Patients who underwent laparoscopic lateral suspension with uterine preservation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 40 to 80 years who underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy for the treatment of pelvic organ prolapse at SBÜ Gaziosmanpaşa Training and Research Hospital between 2021 and 2024. All patients had at least 12 months of postoperative follow-up, and data were collected retrospectively from medical records.
Key inclusion criteria (5 listed)
- Female patients aged 40 to 80 years
- Diagnosis of pelvic organ prolapse (POP) requiring surgical management
- Underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy
- Minimum of 12 months postoperative follow-up available
- Ability to provide informed consent for use of medical data in this retrospective study
Key exclusion criteria (5 listed)
- History of connective tissue disorders
- History of prior pelvic reconstructive surgery
- Active pelvic infection or suspected malignancy at the time of surgery
- Severe systemic disease that could significantly affect surgical outcomes
- Incomplete medical records or missing follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomical Success Based on POP-Q System
Time frame: 12 months after surgery
Primary Outcome Title: Number of Participants Achieving Anatomical Success Based on POP-Q System Description: Anatomical success is defined as all assessed POP-Q points (Aa, Ba, C, D, Ap, Bp) being at or above -1 cm (no prolapse extending more than 1 cm below the hymen). POP-Q scale values: Negative values indicate the point is above the hymen (better anatomy), positive values indicate prolapse below the hymen (worse anatomy). Typical range: Aa, Ba, Ap, Bp = -3 to +3 cm; C and D vary according to total vaginal length (TVL). Time Frame: 12 months after surgery
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 6 Aug 2025.
- Background: PubMed 36196844Kumbasar S, Salman S, Sogut O, K Gencer F, Bacak HB, Tezcan AD, Timur GY. Uterine-sparing laparoscopic lateral suspension in the treatment of pelvic organ prolapse. J Obstet Gynaecol Res. 2023 Jan;49(1):341-349. doi: 10.1111/jog.15459. Epub 2022 Oct 5.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is based on retrospective medical record review and no consent for data sharing was obtained from participants. All data are stored and analyzed internally according to institutional policies and ethical approvals.
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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?
An observational study of Pelvic Organ Prolapse (POP) and Uterine Prolapse, run by Havva Betül Bacak 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 5 inclusion and 5 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 6 Aug 2025. 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?
Anatomical Success Based on POP-Q System (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07094815, which also lists 1 linked publication.
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 6 Aug 2025.