Pelvic Organ ProlapseSSLF-CSINCT03782285
Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
An observational study of Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 9 sites in China.
Trial summary
SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally. It is usually accomplished with specially designed equipment in English-language scientific literature. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- sacrospinous Ligament Fixation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 9 sitesChina
- Study dates
- 23 Nov 2018to Sep 2019
- How long will I take part?
- 3 Years
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with apical prolapse with POP-Q III or IV who are planned to have unilateral SSLF is planned
Who may be able to join
- Women with apical prolapse with POP-Q III or IV
- Unilateral (all sutured to right sacrospinous ligament) SSLF is planned，while with vaginal hysterectomy, anterior/posterior vaginal wall repair or mid-urethral suspension could be performed simultaneously.
- Women who have been eligible for long-term follow-up.
- Women who agreed to participate in the study and signed informed consent.
Who cannot join
- Women who have surgical history for prolapse
- Women who have contraindication for surgical procedure
- Women who are unable to comply with the study procedures
Trial locations and contacts
9 sites in 1 country.
Lan Zhu, MD contact
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
1st Affiliated hospital of PLA general hospital
Beijing, Beijing Municipality, 100037
Yongxian Lu
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yuxin Dai, MD, 0086-010-69156204, helen81918@163.com
Lan Zhu
- Recruiting
Chongqing Women's and Children's Hospital
Chongqing, Chongqing Municipality, 400021
Lubin Liu
- Recruiting
Foshan Women's and Children's Hospital
Foshan, Guangdong, 528000
Yuling Wang
- Recruiting
Hangzhou Women's and Children's Hospital
Hangzhou, Zhejiang, 310008
Xiangjuan Li
- Recruiting
2nd Affiliated hospital of Anhui Medical college
Hefei, Anhui, 230041
Wenyan Wang
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200040
Zhiyuan Dai
- Recruiting
Suzhou City Hospital
Suzhou, Jiangsu, 215008
Shunyu Hou
- Recruiting
Shan'xi Province Women's and Children's Hospital
Taiyuan, Shanxi, 300013
Zhaoai Li
About this study
Official title: Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center Prospective Clinical Trial
SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally. It is usually accomplished with specially designed equipment in English-language scientific literature. However, these instruments either reusable or disposable are relatively expensive and difficult in accessibility, and are not yet widely applied around China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument.
Read the detailed description
Apical prolapse is defined as descent of the uterus and cervix, the cervix alone, or the post-hysterectomy vaginal cuff down to the hymen, lower vagina, or past the introitus. Among 684,250 POP procedures that were performed in 15 Organization for Economic Co-operation and Development (OECD) countries in 2012, apical compartment repairs represented 20% of these procedures. Sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally usually with specially designed equipment such as Deschamps ligature carrier or Miya hook. However, these instruments are expensive and are not yet widely applied in China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument. Previous pilot study from Peking Union Medical College Hospital showed promising curative results with conventional surgical instruments in Chinese female patients. The investigation may show us a feasible, economic and effective modified procedure for Asian patients with medium compartment prolapse.
This is a multi-center, prospective clinical trial. Previous studies using conventional surgical instruments for 1-year follow-up showed objective cure rate was 98%, subjective satisfaction was 94%, Considering that the objective cure rate may decrease in multicenter trials, it is assumed that the objective cure rate of multicenter trials can reach 95%. When the sample size is at least 79 patients, 80% of the test efficiency can verify that the objective cure rate is higher than the target value when the bilateral α=0.05. The missing rate was about 10%. The incidence of SSLF failure requiring other operations method due to deep pelvic cavity and unsatisfactory exposure by conventional instruments was about 5%. The final number of cases included in this study should be 100 cases. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia. The research units will collect perioperative data and complete unified format case report form (CRF) for all selected patients for further analysis. A total of at most 9 months will be required to complete the study after starting up.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- sacrospinous Ligament Fixation
- Keywords
- apical prolapse, sacrospinous Ligament Fixation
- 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
Also called ischial spinous fascia fixation
sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of SSLF with conventional instruments
- Symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?".
- The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire.
- There is no need of further treatment for prolapse, such as reoperation or pessary.
- Pelvic MRI evaluation on postoperative 3 months follow-up
Measured: up to 36 months after operation
Secondary outcomes (6)
Postoperative recurrence
Evaluation on the prolapse of the anterior, middle and posterior pelvic confirms POP-Q II degrees and above.
Measured: from 3 months after operation up to 36 months after operation
visual analogue scales
postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain)
Measured: within 3 days after operation
symptomatic improvement using validated instruments(PFIQ-7)
Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
Measured: up to 36 months after operation
symptomatic improvement using validated instruments(PFDI-20)
Relief of symptoms using validated instruments, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.
Measured: up to 36 months after operation
symptomatic improvement using validated instruments(PISQ-12)
Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
Measured: up to 36 months after operation
symptomatic improvement using patient global impression of change (PGI-C)
Relief of symptoms using patient global impression of change (PGI-C)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.
Measured: up to 36 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start23 Nov 2018
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital, Shanghai First Maternity and Infant Hospital, The Second Hospital of Anhui Medical University, Shanxi Provincial Maternity and Children's Hospital, Foshan Women's and Children's Hospital, Suzhou Municipal Hospital, Chongqing Maternal and Child Health Hospital, Hangzhou Maternal and Child Health Hospital, Beijing Obstetrics and Gynecology Hospital, Peking Union Medical College, St. Francis Hospital, Chicago, USA, University of Texas, Southwestern Medical Center at Dallas
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, Study chair, Peking Union Medical College HospitalYongxian Lu, Principal investigator, 1st Affiliated hospital of PLA general hospitalZhiyuan Dai, Principal investigator, Shanghai First Maternity and Infant HospitalWenyan Wang, Principal investigator, 2nd Affiliated hospital of Anhui Medical collegeZhaoai Li, Principal investigator, Shan'xi Province Women's and Children's HospitalYuling Wang, Principal investigator, Foshan Women's and Children's HospitalShunyu Hou, Principal investigator, Suzhou City HospitalLubin Liu, Principal investigator, Chongqing Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782285
- Sponsor's protocol ID
- PekingUnion：SSLF-CSI
- Acronym
- SSLF-CSI
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.
PubMed 25724403Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
PubMed 24142057Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.
PubMed 28647958
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03782285
- Acronym / sponsor ID
- SSLF-CSI / PekingUnion：SSLF-CSI
- Conditions
- Pelvic Organ Prolapse
- Keywords
- apical prolapse, sacrospinous Ligament Fixation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital, Shanghai First Maternity and Infant Hospital, The Second Hospital of Anhui Medical University, Shanxi Provincial Maternity and Children's Hospital, Foshan Women's and Children's Hospital, Suzhou Municipal Hospital, Chongqing Maternal and Child Health Hospital, Hangzhou Maternal and Child Health Hospital, Beijing Obstetrics and Gynecology Hospital, Peking Union Medical College, St. Francis Hospital, Chicago, USA, University of Texas, Southwestern Medical Center at Dallas
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 20 Dec 2018 (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.
SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally. It is usually accomplished with specially designed equipment in English-language scientific literature. However, these instruments either reusable or disposable are relatively expensive and difficult in accessibility, and are not yet widely applied around China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument.
Detailed description
Apical prolapse is defined as descent of the uterus and cervix, the cervix alone, or the post-hysterectomy vaginal cuff down to the hymen, lower vagina, or past the introitus. Among 684,250 POP procedures that were performed in 15 Organization for Economic Co-operation and Development (OECD) countries in 2012, apical compartment repairs represented 20% of these procedures. Sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally usually with specially designed equipment such as Deschamps ligature carrier or Miya hook. However, these instruments are expensive and are not yet widely applied in China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument. Previous pilot study from Peking Union Medical College Hospital showed promising curative results with conventional surgical instruments in Chinese female patients. The investigation may show us a feasible, economic and effective modified procedure for Asian patients with medium compartment prolapse.
This is a multi-center, prospective clinical trial. Previous studies using conventional surgical instruments for 1-year follow-up showed objective cure rate was 98%, subjective satisfaction was 94%, Considering that the objective cure rate may decrease in multicenter trials, it is assumed that the objective cure rate of multicenter trials can reach 95%. When the sample size is at least 79 patients, 80% of the test efficiency can verify that the objective cure rate is higher than the target value when the bilateral α=0.05. The missing rate was about 10%. The incidence of SSLF failure requiring other operations method due to deep pelvic cavity and unsatisfactory exposure by conventional instruments was about 5%. The final number of cases included in this study should be 100 cases. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia. The research units will collect perioperative data and complete unified format case report form (CRF) for all selected patients for further analysis. A total of at most 9 months will be required to complete the study after starting up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with apical prolapse with POP-Q III or IV who are planned to have unilateral SSLF is planned
Key inclusion criteria (4 listed)
- Women with apical prolapse with POP-Q III or IV
- Unilateral (all sutured to right sacrospinous ligament) SSLF is planned，while with vaginal hysterectomy, anterior/posterior vaginal wall repair or mid-urethral suspension could be performed simultaneously.
- Women who have been eligible for long-term follow-up.
- Women who agreed to participate in the study and signed informed consent.
Key exclusion criteria (3 listed)
- Women who have surgical history for prolapse
- Women who have contraindication for surgical procedure
- Women who are unable to comply with the study procedures
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 FixationAlso: ischial spinous fascia fixationsacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia. | Procedure or surgery | – |
Primary outcome
Success rate of SSLF with conventional instruments
Time frame: up to 36 months after operation
1. Symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". 2. The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. 3. There is no need of further treatment for prolapse, such as reoperation or pessary. 4. Pelvic MRI evaluation on postoperative 3 months follow-up
6 secondary outcomes
Postoperative recurrence
Time frame: from 3 months after operation up to 36 months after operation
visual analogue scales
Time frame: within 3 days after operation
symptomatic improvement using validated instruments(PFIQ-7)
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PFDI-20)
Time frame: up to 36 months after operation
symptomatic improvement using validated instruments(PISQ-12)
Time frame: up to 36 months after operation
symptomatic improvement using patient global impression of change (PGI-C)
Time frame: up to 36 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Results publication: PubMed 25724403Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.
- Results publication: PubMed 24142057Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
- Results publication: PubMed 28647958Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Lan Zhu, MD contact
Lan Zhu study chair
Peking Union Medical College Hospital
Yongxian Lu principal investigator
1st Affiliated hospital of PLA general hospital
Zhiyuan Dai principal investigator
Shanghai First Maternity and Infant Hospital
9 sites 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, run by Peking Union Medical College Hospital at 9 sites in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxin Dai, MD (0086-010-69156204, helen81918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of SSLF with conventional instruments (time frame: up to 36 months after operation). 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 NCT03782285, which also lists 3 linked publications.
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 20 Dec 2018.