Clinical trial NCT03782285: Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
Official title: Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center Prospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: apical prolapse
sacrospinous Ligament Fixation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: First Hospitals affiliated to the China PLA General Hospital
name: Shanghai First Maternity and Infant Hospital
name: The Second Hospital of Anhui Medical University
name: Shanxi Provincial Maternity and Children's Hospital
name: Foshan Women's and Children's Hospital
name: Suzhou Municipal Hospital
name: Chongqing Maternal and Child Health Hospital
name: Hangzhou Maternal and Child Health Hospital
name: Beijing Obstetrics and Gynecology Hospital
name: Peking Union Medical College
name: St. Francis Hospital, Chicago, USA
name: University of Texas, Southwestern Medical Center at Dallas
First posted: 2018-12-20
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with apical prolapse with POP-Q III or IV who are planned to have unilateral SSLF is planned

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Women with apical prolapse with POP-Q III or IV
2. 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.
3. Women who have been eligible for long-term follow-up.
4. Women who agreed to participate in the study and signed informed consent.

Exclusion Criteria:

1. Women who have surgical history for prolapse
2. Women who have contraindication for surgical procedure
3. Women who are unable to comply with the study procedures

Primary outcomes:
measure: Success rate of SSLF with conventional instruments
timeFrame: up to 36 months after operation
Secondary outcomes:
measure: Postoperative recurrence
timeFrame: from 3 months after operation up to 36 months after operation
measure: visual analogue scales
timeFrame: within 3 days after operation
measure: symptomatic improvement using validated instruments(PFIQ-7)
timeFrame: up to 36 months after operation
measure: symptomatic improvement using validated instruments(PFDI-20)
timeFrame: up to 36 months after operation
measure: symptomatic improvement using validated instruments(PISQ-12)
timeFrame: up to 36 months after operation
measure: symptomatic improvement using patient global impression of change (PGI-C)
timeFrame: up to 36 months after operation
Other outcomes:
Locations:
city: Hefei
country: China
facility: 2nd Affiliated hospital of Anhui Medical college
state: Anhui
city: Beijing
country: China
facility: 1st Affiliated hospital of PLA general hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Women's and Children's Hospital
state: Chongqing
city: Foshan
country: China
facility: Foshan Women's and Children's Hospital
state: Guangdong
city: Suzhou
country: China
facility: Suzhou City Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shan'xi Province Women's and Children's Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Hangzhou Women's and Children's Hospital
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: STUDY_CHAIR
affiliation: 1st Affiliated hospital of PLA general hospital
name: Yongxian Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai First Maternity and Infant Hospital
name: Zhiyuan Dai
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated hospital of Anhui Medical college
name: Wenyan Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Shan'xi Province Women's and Children's Hospital
name: Zhaoai Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Foshan Women's and Children's Hospital
name: Yuling Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou City Hospital
name: Shunyu Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing Women's and Children's Hospital
name: Lubin Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou Women's and Children's Hospital
name: Xiangjuan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Le Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: Statistics Department of Peking Union Medical College
name: Tao Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center
name: Joseph Schaffer
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Francis Hospital
name: Marko J Jachtorowycz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
citation: Ren 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.