Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients

Pelvic Organ Prolapse Clinical Trial

— SSLF-CSI  

Official title:

Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03782285
• Other study ID #: PekingUnion:SSLF-CSI
• Status: Recruiting
• Start date: November 23, 2018
• Est. completion date: September 2019

Study information

• Verified date: December 2018
• Source: Peking Union Medical College Hospital
• Contact: Yuxin Dai, MD
• Phone: 0086-010-69156204
• Email: helen81918[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• sacrospinous Ligament 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.

Locations

Country	Name	City	State
China	1st Affiliated hospital of PLA general hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Chongqing Women's and Children's Hospital	Chongqing	Chongqing
China	Foshan Women's and Children's Hospital	Foshan	Guangdong
China	Hangzhou Women's and Children's Hospital	Hangzhou	Zhejiang
China	2nd Affiliated hospital of Anhui Medical college	Hefei	Anhui
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai
China	Suzhou City Hospital	Suzhou	Jiangsu
China	Shan'xi Province Women's and Children's Hospital	Taiyuan	Shanxi

Sponsors (13)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Beijing Obstetrics and Gynecology Hospital, Chongqing Maternal and Child Health Hospital, First Hospitals affiliated to the China PLA General Hospital, Foshan Women and Children’s Hospital, Hangzhou Maternal and Child Health Hospital, Peking Union Medical College, Shanghai First Maternity and Infant Hospital, Shanxi Provincial Maternity and Children's Hospital, St. Francis Hospital, Chicago, USA, Suzhou Municipal Hospital, The Second Hospital of Anhui Medical University, University of Texas, Southwestern Medical Center at Dallas

Country where clinical trial is conducted

China, 

References & Publications (3)

Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. Review. — View 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 Develo — View 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 ?-? pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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