Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients (SSLF-CSI)

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: sacrospinous Ligament Fixation

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yuxin Dai, MD; Phone Number: 0086-010-69156204; Email: helen81918@163.com
• Study Contact Backup: Name: Lan Zhu, MD

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230041
      • Recruiting
      • 2nd Affiliated hospital of Anhui Medical college
      • Contact: Wenyan Wang
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yuxin Dai, MD; Phone Number: 0086-010-69156204; Email: helen81918@163.com
      • Contact: Lan Zhu
    • Beijing, Beijing, China, 100037
      • Recruiting
      • 1st Affiliated hospital of PLA general hospital
      • Contact: Yongxian Lu
  • Chongqing
    • Chongqing, Chongqing, China, 400021
      • Recruiting
      • Chongqing Women's and Children's Hospital
      • Contact: Lubin Liu
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Foshan Women's and Children's Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China, 215008
      • Recruiting
      • Suzhou City Hospital
      • Contact: Shunyu Hou
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Shanghai first maternity and infant hospital
      • Contact: Zhiyuan Dai
  • Shanxi
    • Taiyuan, Shanxi, China, 300013
      • Recruiting
      • Shan'xi Province Women's and Children's Hospital
      • Contact: Zhaoai Li
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310008
      • Recruiting
      • Hangzhou Women's and Children's Hospital
      • Contact: Xiangjuan Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 36 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recurrence	Evaluation on the prolapse of the anterior, middle and posterior pelvic confirms POP-Q II degrees and above.	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)	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.	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.	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.	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.	up to 36 months after operation

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Peking Union Medical College; Shanghai First Maternity and Infant Hospital; The Second Hospital of Anhui Medical University; First Hospitals affiliated to the China PLA General Hospital; Suzhou Municipal Hospital; Beijing Obstetrics and Gynecology Hospital; Shanxi Provincial Maternity and Children's Hospital; University of Texas, Southwestern Medical Center at Dallas; Chongqing Maternal and Child Health Hospital; Hangzhou Maternal and Child Health Hospital; Foshan Women and Children's Hospital; St. Francis Hospital, Chicago, USA
• Investigators: Principal Investigator: Yongxian Lu, 1st Affiliated hospital of PLA general hospital; Principal Investigator: Zhiyuan Dai, Shanghai first maternity and infant hospital; Principal Investigator: Wenyan Wang, 2nd Affiliated hospital of Anhui Medical college; Principal Investigator: Zhaoai Li, Shan'xi Province Women's and Children's Hospital; Principal Investigator: Yuling Wang, Foshan Women's and Children's Hospital; Principal Investigator: Shunyu Hou, Suzhou City Hospital; Principal Investigator: Xiangjuan Li, Hangzhou Women's and Children's Hospital; Principal Investigator: Lubin Liu, Chongqing Women's and Children's Hospital; Principal Investigator: Le Ma, Beijing Obstetrics and Gynecology Hospital; Principal Investigator: Tao Xu, Statistics Department of Peking Union Medical College; Principal Investigator: Joseph Schaffer, UT Southwestern Medical Center; Principal Investigator: Marko J Jachtorowycz, Saint Francis Memorial Hospital; Study Chair: Lan Zhu, Peking Union Medical College Hospital

Publications and helpful links

General 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.
• Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: apical prolapse; sacrospinous Ligament Fixation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PekingUnion：SSLF-CSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No