Pelvic FloorNCT03620565
The Follow-up of Mesh/Native Tissue Complications Study(Part I)
An observational study of Pelvic Floor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to investigate the incidence and distribution of complications after different pelvic reconstruction surgeries using mesh/native tissue in multi-centers using the IUGA/ICS complication classification system(the Category-Time-Site(CTS) coding). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Floor
- How many people
- 13,120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to Dec 2023
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo different pelvic floor reconstructive surgeries for the cure of pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) between June 2018 and June 2023 from 27 tertiary hospitals are prospectively collected.
Who may be able to join
- 1. Patients who undergo pelvic floor reconstructive surgeries for pelvic organ prolapse and/or stress urinary incontinence. The aimed pelvic floor reconstructive surgeries involve anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh, open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation and so on) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape). The indications are respectively as follows:
- Total pelvic reconstruction with trans-vaginal mesh Indications: 1) Patients experienced recurrence of prolapse in the same compartment that has a history of pelvic floor repair surgery; 2) The choice for elder patients who will accept primary surgery for advanced POP (staging III or IV).
- Open/Laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh) Indications: 1) Presenting with at least 3 prolapse of the uterus, with or without concomitant cystocele and rectocele; 2) Symptomatic stage 2 or greater prolapse of the vaginal vault or apical recurrence.
- Repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, Lefort) Indications:1)Presenting symptomatic stage 2 or greater prolapse of the uterus, with or without concomitant cystocele and rectocele. The procedure(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation) usually is performed after hysterectomy or when the uterus is preserved. 2)If postmenopausal women present with advanced uterus or vaginal apex prolapse, and have no desire of sexual life, the Lefort operation would be performed.
- Anti-urinary incontinence surgeries: tension-free vaginal tape. Indications: Stress urinary incontinence(SUI) patients who have 1）hyperactivity of urethra, or 2）internal urethral sphincter disorder; Or 3）mainly presenting SUI symptoms in patients with mixed urinary incontinence.
- 2. The failure or recurrence of prolapse the same compartment that has been underwent repair using native tissue.
Who cannot join
- (1) the recurrence occurred on the same pelvic compartment with a prior history of prolapse repair surgery using mesh, an implant or a graft; (2) a prior history of anti-incontinence surgery using tape; however, patients who are inferred to accept procedures for POP this time are not included; (3) acute/chronic pelvic inflammation, genital tract infections；(4) any severe medical diseases that precluded the operations.
Trial locations and contacts
1 site in 1 country.
Lan Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, 100730
Shuo Liang, MD, 13718879529, leahleung@foxmail.com
About this study
Official title: A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part I)
This study aims to investigate the incidence and distribution of complications after different pelvic reconstruction surgeries using mesh/native tissue in multi-centers using the IUGA/ICS complication classification system(the Category-Time-Site(CTS) coding).
Read the detailed description
Patients who undergo different pelvic floor reconstructive surgeries for the cure of pelvic organ prolapse(POP)and/or stress urinary incontinence(SUI) between June 2018 and June 2023 from 27 tertiary hospitals are prospectively collected.Our study aims to follow-up and report the incidences of postoperative complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system).The aimed pelvic floor reconstructive surgeries involve anterior,apical, posterior or total pelvic reconstruction with trans-vaginal mesh,open/laparoscopic sacrocolpopexy(Y-tape/self-cut synthesized mesh),repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension,ischial spinous fascia fixation, the Lefort operation and so on)and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
Our follow-up process start after patients have completed the operation,thus our study do not affect patients' choice of surgical method.
- Conditions
- Pelvic Floor
- Keywords
- Pelvic floor reconstructive surgery, Mesh, Native tissue, Tape, Complication, the CTS coding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sacrocolpopexy(LSC) | Patients who prefer to accept laparoscopic sacrocolpopexy after hysterectomy. For patients who has desire of uterine-preservation,laparoscopic sacrocervicopexy or sacrohysteropexy is carried. | |
| Reconstruction with transvaginal mesh(TVM) | Patients who undertake pelvic reconstruction with tran-vaginal mesh(commercial mesh kits or self-cut synthesized mesh). | |
| Reconstruction with native tissue(NT) | Patients who prefer to accept reconstruction with native tissue,mainly including high uterosacral ligament suspension, sacrospinous ligament fixation,ischial spinous fascia fixation,the Lefort operation. | |
| Tension-free vaginal tape surgery(TVT) | Patients who undertake anti-incontinence surgeries(tension-free vaginal tape procedure). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: at 6-week postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: at 3-month postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: at 1-year postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: at 2-year postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
Measured: up to 3-year postoperatively
Secondary outcomes (2)
Anatomical cure rates in treated compartment of different pelvic reconstructive surgeries
The percentage of patients who reach the anatomical success criteria at each time point（6 weeks, 3 months and each year, up to 3-year postoperatively）
Measured: 6 weeks, 3 months and each year, up to 3-year postoperatively
Change from Preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
POP-Q is used for evaluation the severity(staging) of prolapse by pelvic examination preoperatively and postoperatively. The score is reported in cm. The changes from baseline scores at 6 weeks, 3 months, 1 year and up to 3 years postoperatively are respectively compared.
Measured: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jun 2018
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic FloorStudies 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
- 13,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, Peking University Third Hospital, First Hospitals affiliated to the China PLA General Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Tongji Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, Wuxi Obsetrics & Gynecology Hospital, Fuzhou General Hospital, First Affiliated Hospital of Jinan University, Women's Hospital School Of Medicine Zhejiang University, Renmin Hospital of Wuhan University, Third Affiliated Hospital of Zhengzhou University, Shengjing Hospital, General Hospital of Ningxia Medical University, The Second Hospital of Hebei Medical University, Gansu Provincial Maternal and Child Health Care Hospital, First Affiliated Hospital of Xinjiang Medical University, Qingdao University, Southwest Hospital, China, West China Second University Hospital, Jiangxi Maternal and Child Health Hospital, Shanxi Coal Central Hospital, Chongqing Medical University
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620565
- Sponsor's protocol ID
- JS-1566-1
- Status last verified
- Jun 2018
- First submitted
- 6 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun ZJ, Wang XQ, Lang JH, Xu T, Lu YX, Hua KQ, Han JS, Li HF, Tong XW, Wang P, Wang JL, Yang X, Huang XH, Liu PS, Song YF, Jin HM, Xie JY, Wang LW, Wu QK, Gong J, Wang Y, Wang LQ, Li ZA, Xu HC, Xia ZJ, Gu LN, Liu Q, Zhu L. A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse. Chin Med J (Engl). 2021 Jan 20;134(2):200-205. doi: 10.1097/CM9.0000000000001237.
PubMed 33443938
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part I)
- ClinicalTrials.gov ID
- NCT03620565
- Acronym / sponsor ID
- JS-1566-1
- Conditions
- Pelvic Floor
- Keywords
- Pelvic floor reconstructive surgery, Mesh, Native tissue, Tape, Complication, the CTS coding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, Peking University Third Hospital, First Hospitals affiliated to the China PLA General Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Tongji Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, Wuxi Obsetrics & Gynecology Hospital, Fuzhou General Hospital, First Affiliated Hospital of Jinan University, Women's Hospital School Of Medicine Zhejiang University, Renmin Hospital of Wuhan University, Third Affiliated Hospital of Zhengzhou University, Shengjing Hospital, General Hospital of Ningxia Medical University, The Second Hospital of Hebei Medical University, Gansu Provincial Maternal and Child Health Care Hospital, First Affiliated Hospital of Xinjiang Medical University, Qingdao University, Southwest Hospital, China, West China Second University Hospital, Jiangxi Maternal and Child Health Hospital, Shanxi Coal Central Hospital, Chongqing Medical University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Aug 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.
This study aims to investigate the incidence and distribution of complications after different pelvic reconstruction surgeries using mesh/native tissue in multi-centers using the IUGA/ICS complication classification system(the Category-Time-Site(CTS) coding).
Detailed description
Patients who undergo different pelvic floor reconstructive surgeries for the cure of pelvic organ prolapse(POP)and/or stress urinary incontinence(SUI) between June 2018 and June 2023 from 27 tertiary hospitals are prospectively collected.Our study aims to follow-up and report the incidences of postoperative complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system).The aimed pelvic floor reconstructive surgeries involve anterior,apical, posterior or total pelvic reconstruction with trans-vaginal mesh,open/laparoscopic sacrocolpopexy(Y-tape/self-cut synthesized mesh),repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension,ischial spinous fascia fixation, the Lefort operation and so on)and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
Our follow-up process start after patients have completed the operation,thus our study do not affect patients' choice of surgical method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sacrocolpopexy(LSC) | – | –Patients who prefer to accept laparoscopic sacrocolpopexy after hysterectomy. For patients who has desire of uterine-preservation,laparoscopic sacrocervicopexy or sacrohysteropexy is carried. |
| Reconstruction with transvaginal mesh(TVM) | – | –Patients who undertake pelvic reconstruction with tran-vaginal mesh(commercial mesh kits or self-cut synthesized mesh). |
| Reconstruction with native tissue(NT) | – | –Patients who prefer to accept reconstruction with native tissue,mainly including high uterosacral ligament suspension, sacrospinous ligament fixation,ischial spinous fascia fixation,the Lefort operation. |
| Tension-free vaginal tape surgery(TVT) | – | –Patients who undertake anti-incontinence surgeries(tension-free vaginal tape procedure). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo different pelvic floor reconstructive surgeries for the cure of pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) between June 2018 and June 2023 from 27 tertiary hospitals are prospectively collected.
Key inclusion criteria (6 listed)
- 1. Patients who undergo pelvic floor reconstructive surgeries for pelvic organ prolapse and/or stress urinary incontinence. The aimed pelvic floor reconstructive surgeries involve anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh, open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation and so on) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape). The indications are respectively as follows:
- Total pelvic reconstruction with trans-vaginal mesh Indications: 1) Patients experienced recurrence of prolapse in the same compartment that has a history of pelvic floor repair surgery; 2) The choice for elder patients who will accept primary surgery for advanced POP (staging III or IV).
- Open/Laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh) Indications: 1) Presenting with at least 3 prolapse of the uterus, with or without concomitant cystocele and rectocele; 2) Symptomatic stage 2 or greater prolapse of the vaginal vault or apical recurrence.
- Repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, Lefort) Indications:1)Presenting symptomatic stage 2 or greater prolapse of the uterus, with or without concomitant cystocele and rectocele. The procedure(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation) usually is performed after hysterectomy or when the uterus is preserved. 2)If postmenopausal women present with advanced uterus or vaginal apex prolapse, and have no desire of sexual life, the Lefort operation would be performed.
- Anti-urinary incontinence surgeries: tension-free vaginal tape. Indications: Stress urinary incontinence(SUI) patients who have 1）hyperactivity of urethra, or 2）internal urethral sphincter disorder; Or 3）mainly presenting SUI symptoms in patients with mixed urinary incontinence.
Key exclusion criteria (1 listed)
- (1) the recurrence occurred on the same pelvic compartment with a prior history of prolapse repair surgery using mesh, an implant or a graft; (2) a prior history of anti-incontinence surgery using tape; however, patients who are inferred to accept procedures for POP this time are not included; (3) acute/chronic pelvic inflammation, genital tract infections；(4) any severe medical diseases that precluded the operations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The frequency and incidence rate of different complications
Time frame: at 6-week postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
The frequency and incidence rate of different complications
Time frame: at 3-month postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
The frequency and incidence rate of different complications
Time frame: at 1-year postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
The frequency and incidence rate of different complications
Time frame: at 2-year postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
The frequency and incidence rate of different complications
Time frame: up to 3-year postoperatively
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).
2 secondary outcomes
Anatomical cure rates in treated compartment of different pelvic reconstructive surgeries
Time frame: 6 weeks, 3 months and each year, up to 3-year postoperatively
Change from Preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
Time frame: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 33443938Sun ZJ, Wang XQ, Lang JH, Xu T, Lu YX, Hua KQ, Han JS, Li HF, Tong XW, Wang P, Wang JL, Yang X, Huang XH, Liu PS, Song YF, Jin HM, Xie JY, Wang LW, Wu QK, Gong J, Wang Y, Wang LQ, Li ZA, Xu HC, Xia ZJ, Gu LN, Liu Q, Zhu L. A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse. Chin Med J (Engl). 2021 Jan 20;134(2):200-205. doi: 10.1097/CM9.0000000000001237.
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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, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor, run by Peking Union Medical College Hospital at 1 site 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 6 inclusion and 1 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shuo Liang, MD (+8613718879529, leahleung@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency and incidence rate of different complications (time frame: at 6-week postoperatively). The study lists 5 primary outcomes in all. 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 NCT03620565, which also lists 1 linked publication.
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 8 Aug 2018.