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

NCT ID: NCT03782285

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-23

Study Completion Date

2019-09-30

Brief Summary

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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

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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

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Pelvic Organ Prolapse

Keywords

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apical prolapse sacrospinous Ligament Fixation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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ischial spinous fascia fixation

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Hospitals affiliated to the China PLA General Hospital

OTHER_GOV

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

Foshan Women's and Children's Hospital

OTHER

Sponsor Role collaborator

Suzhou Municipal Hospital

OTHER

Sponsor Role collaborator

Chongqing Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Hangzhou Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College

OTHER

Sponsor Role collaborator

St. Francis Hospital, Chicago, USA

UNKNOWN

Sponsor Role collaborator

University of Texas, Southwestern Medical Center at Dallas

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan Zhu

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Yongxian Lu

Role: PRINCIPAL_INVESTIGATOR

1st Affiliated hospital of PLA general hospital

Zhiyuan Dai

Role: PRINCIPAL_INVESTIGATOR

Shanghai First Maternity and Infant Hospital

Wenyan Wang

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated hospital of Anhui Medical college

Zhaoai Li

Role: PRINCIPAL_INVESTIGATOR

Shan'xi Province Women's and Children's Hospital

Yuling Wang

Role: PRINCIPAL_INVESTIGATOR

Foshan Women's and Children's Hospital

Shunyu Hou

Role: PRINCIPAL_INVESTIGATOR

Suzhou City Hospital

Lubin Liu

Role: PRINCIPAL_INVESTIGATOR

Chongqing Women's and Children's Hospital

Xiangjuan Li

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Women's and Children's Hospital

Le Ma

Role: PRINCIPAL_INVESTIGATOR

Beijing Obstetrics and Gynecology Hospital

Tao Xu

Role: PRINCIPAL_INVESTIGATOR

Statistics Department of Peking Union Medical College

Joseph Schaffer

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Marko J Jachtorowycz

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Locations

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2nd Affiliated hospital of Anhui Medical college

Hefei, Anhui, China

Site Status RECRUITING

1st Affiliated hospital of PLA general hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing Women's and Children's Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Foshan Women's and Children's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Suzhou City Hospital

Suzhou, Jiangsu, China

Site Status RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shan'xi Province Women's and Children's Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

Hangzhou Women's and Children's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuxin Dai, MD

Role: CONTACT

Phone: 0086-010-69156204

Email: [email protected]

Lan Zhu, MD

Role: CONTACT

Facility Contacts

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Wenyan Wang

Role: primary

Yongxian Lu

Role: primary

Yuxin Dai, MD

Role: primary

Lan Zhu

Role: backup

Lubin Liu

Role: primary

Yuling Wang

Role: primary

Shunyu Hou

Role: primary

Zhiyuan Dai

Role: primary

Zhaoai Li

Role: primary

Xiangjuan Li

Role: primary

References

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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.

Reference Type RESULT
PMID: 25724403 (View on PubMed)

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

Reference Type RESULT
PMID: 24142057 (View on PubMed)

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.

Reference Type RESULT
PMID: 28647958 (View on PubMed)

Other Identifiers

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PekingUnion：SSLF-CSI

Identifier Type: -

Identifier Source: org_study_id