Pelvic Organ ProlapseNCT07106866
LOOP VS DOUBLE SUTURE TECHNIQUES IN SACROSPINOUS FIXATION: A TWO-YEAR STUDY
An observational study of Pelvic Organ Prolapse and Surgical Procedure; Complications, Late Effect of Complications, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective cohort study aimed to compare clinical outcomes between the classical double suture technique and a modified loop suture technique used in sacrospinous ligament fixation for stage 3 or 4 pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Surgical Procedure; Complications, Late Effect of Complications
- What is being tested?
- sacrospinous ligament fixation
- Type of treatment
- Surgery or procedure
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jan 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 30 to 80 years
- Women only
- Adult, Older adult
Study population: Women aged 30 to 80 years with stage 3 or 4 apical pelvic organ prolapse who underwent sacrospinous ligament fixation at a tertiary urogynecology center. All patients were treated between January 2020 and January 2023.
Who may be able to join
- Stage 3 or 4 apical pelvic organ prolapse
- Underwent SSF between Jan 2020 and Jan 2023
Who cannot join
- Concomitant malignancy
- Previous apical prolapse surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul, Türkiye, 34668
About this study
Official title: A Comparative Evaluation of Double Versus Loop Suture Techniques in Sacrospinous Ligament Fixation Over Two Years
This retrospective cohort study aimed to compare clinical outcomes between the classical double suture technique and a modified loop suture technique used in sacrospinous ligament fixation for stage 3 or 4 pelvic organ prolapse. A total of 195 patients underwent surgery at a tertiary care center between January 2020 and January 2023. The primary outcome was the rate of reoperation due to recurrence within 24 months. Secondary outcomes included operative time, prolapse recurrence rate, and postoperative complications such as gluteal pain. The study was designed to evaluate whether a simplified suture method could improve surgical efficiency and patient recovery without compromising anatomical success.
Read the detailed description
Sacrospinous ligament fixation is a commonly used surgical procedure for apical pelvic organ prolapse, particularly in women with advanced-stage prolapse who desire a native tissue repair approach. With increasing concerns regarding mesh-related complications, sacrospinous fixation has regained popularity as a mesh-free alternative.
This retrospective cohort study was conducted to evaluate and compare the clinical performance of two different suture techniques: the classical double suture method and a modified loop suture method. The main objective was to assess whether the loop suture technique, which involves a single point of tension, offers advantages in terms of operative efficiency and patient outcomes.
A total of 195 patients with stage 3 or 4 pelvic organ prolapse underwent sacrospinous ligament fixation between January 2020 and January 2023 at a tertiary urogynecology center. One group received the standard double suture technique, while the other underwent fixation using a single loop suture. All surgeries were performed by the same experienced surgical team.
The primary outcome was reoperation rate due to recurrence within 24 months. Secondary outcomes included total operative time, recurrence rate (as defined by POP-Q stage ≥2), and postoperative complications such as gluteal pain and rectal injury.
This study aims to provide evidence on whether a technical modification in a widely accepted native tissue repair procedure can improve surgical safety and reduce long-term complication rates.
- Being tested
- sacrospinous ligament fixation
- Keywords
- urogynecology, pelvic organ prolapse, sacrospinous ligament fixation, prolapse recurrence
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacrospinous ligament fixationProcedure or surgery
A longitudinal incision was made at the midline of the posterior vaginal wall, extending approximately 2-3 cm from the perineal body to the vaginal apex to form a tunnel. The incised vaginal epithelium was dissected from the underlying muscularis layer. Dissection was continued to the level of the ischial spine. The rectum was medialized to access the perirectal space. Upon palpating the ischial spine, the sacrospinous ligament was identified medial to it. Long retractors were placed over the ischial spine to protect the pudendal neurovascular structures. The bladder was retracted superiorly, and the rectum medially, for optimal visualization. Two separate or a loop 1-0 polypropylene suture(s) were placed approximately 1.5 fingerbreadths medial to the ischial spine on the ligament using a needle holder. These sutures were passed through the posterior vaginal tunnel to the apex and tied to secure the vaginal apex to the ligament
| Study group | Role | What they receive |
|---|---|---|
| Double Suture Technique | Double Suture Technique - classical SSF using two individual permanent sutures. Receives: Procedure: sacrospinous ligament fixation | |
| Loop Suture Technique | Loop Suture Technique - SSF using a single loop-style suture Receives: Procedure: sacrospinous ligament fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation rate
Reoperation rate due to prolapse recurrence within 24 months
Measured: 24 months
Secondary outcomes (3)
Total operative time (in minutes)
Measured: up to 200 minutes
Postoperative complications (e.g. gluteal pain, hematoma)
Measured: 24 months
Prolapse recurrence rate (Stage ≥2 on POP-Q)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Betul Albayrak Denizli, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106866
- Sponsor's protocol ID
- SSFtecnique
- Status last verified
- Jul 2025
- First submitted
- 3 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
- Undecided
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
- A Comparative Evaluation of Double Versus Loop Suture Techniques in Sacrospinous Ligament Fixation Over Two Years
- ClinicalTrials.gov ID
- NCT07106866
- Acronym / sponsor ID
- SSFtecnique
- Keywords
- urogynecology, pelvic organ prolapse, sacrospinous ligament fixation, prolapse recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 6 Aug 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 retrospective cohort study aimed to compare clinical outcomes between the classical double suture technique and a modified loop suture technique used in sacrospinous ligament fixation for stage 3 or 4 pelvic organ prolapse. A total of 195 patients underwent surgery at a tertiary care center between January 2020 and January 2023. The primary outcome was the rate of reoperation due to recurrence within 24 months. Secondary outcomes included operative time, prolapse recurrence rate, and postoperative complications such as gluteal pain. The study was designed to evaluate whether a simplified suture method could improve surgical efficiency and patient recovery without compromising anatomical success.
Detailed description
Sacrospinous ligament fixation is a commonly used surgical procedure for apical pelvic organ prolapse, particularly in women with advanced-stage prolapse who desire a native tissue repair approach. With increasing concerns regarding mesh-related complications, sacrospinous fixation has regained popularity as a mesh-free alternative.
This retrospective cohort study was conducted to evaluate and compare the clinical performance of two different suture techniques: the classical double suture method and a modified loop suture method. The main objective was to assess whether the loop suture technique, which involves a single point of tension, offers advantages in terms of operative efficiency and patient outcomes.
A total of 195 patients with stage 3 or 4 pelvic organ prolapse underwent sacrospinous ligament fixation between January 2020 and January 2023 at a tertiary urogynecology center. One group received the standard double suture technique, while the other underwent fixation using a single loop suture. All surgeries were performed by the same experienced surgical team.
The primary outcome was reoperation rate due to recurrence within 24 months. Secondary outcomes included total operative time, recurrence rate (as defined by POP-Q stage ≥2), and postoperative complications such as gluteal pain and rectal injury.
This study aims to provide evidence on whether a technical modification in a widely accepted native tissue repair procedure can improve surgical safety and reduce long-term complication rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Suture Technique | – | Procedure: sacrospinous ligament fixationDouble Suture Technique - classical SSF using two individual permanent sutures. |
| Loop Suture Technique | – | Procedure: sacrospinous ligament fixationLoop Suture Technique - SSF using a single loop-style suture |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women aged 30 to 80 years with stage 3 or 4 apical pelvic organ prolapse who underwent sacrospinous ligament fixation at a tertiary urogynecology center. All patients were treated between January 2020 and January 2023.
Key inclusion criteria (2 listed)
- Stage 3 or 4 apical pelvic organ prolapse
- Underwent SSF between Jan 2020 and Jan 2023
Key exclusion criteria (2 listed)
- Concomitant malignancy
- Previous apical prolapse surgery
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 |
|---|---|---|
| sacrospinous ligament fixationA longitudinal incision was made at the midline of the posterior vaginal wall, extending approximately 2-3 cm from the perineal body to the vaginal apex to form a tunnel. The incised vaginal epithelium was dissected from the underlying muscularis layer. Dissection was continued to the level of the ischial spine. The rectum was medialized to access the perirectal space. Upon palpating the ischial spine, the sacrospinous ligament was identified medial to it. Long retractors were placed over the ischial spine to protect the pudendal neurovascular structures. The bladder was retracted superiorly, and the rectum medially, for optimal visualization. Two separate or a loop 1-0 polypropylene suture(s) were placed approximately 1.5 fingerbreadths medial to the ischial spine on the ligament using a needle holder. These sutures were passed through the posterior vaginal tunnel to the apex and tied to secure the vaginal apex to the ligament | Procedure or surgery | Double Suture Technique, Loop Suture Technique |
Primary outcome
Reoperation rate
Time frame: 24 months
Reoperation rate due to prolapse recurrence within 24 months
3 secondary outcomes
Total operative time (in minutes)
Time frame: up to 200 minutes
Postoperative complications (e.g. gluteal pain, hematoma)
Time frame: 24 months
Prolapse recurrence rate (Stage ≥2 on POP-Q)
Time frame: 24 months
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.
- Individual participant dataSharing planned: Undecided
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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 and Surgical Procedure; Complications, Late Effect of Complications, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 2 inclusion and 2 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?
Reoperation rate (time frame: 24 months). 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 6 Aug 2025.