Pelvic Organ ProlapseNCT03617211
The Follow-up of Mesh/Native Tissue Complications Study(Part II)
An observational study of Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 5 sites in China.
Trial summary
To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 1,530 participants
- Where
- 5 sitesChina
- 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 are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at our participating hospitals but also from other hospital.And the date of surgeries carried is not restricted during the study period.
Who may be able to join
- 1) Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
- 2) Pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
- 3) Both primary and repeated pelvic surgery are included.
Who cannot join
- If the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for "the same code complication in other 26 hospitals, she will be ruled out.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
First Affiliated Hospital of PLA General Hospital (304)
Beijing, Beijing Municipality, 100037
Ke Niu, MD
Yongxian Lu, MD, +86 13520476024, yongxianlu@sina.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Shuo Liang, MD, +86 13718879529, leahleung@foxmail.com
Lan Zhu, MD, +86 13911714696, zhu_julie@vip.sina.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
MD, +86 13609086710, xwzhang81341235@163.com
Xiaowei Zhang, MD
- Recruiting
Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
Shanghai, Shanghai Municipality, 200011
Xiaojuan Wang, MD
Keqin Hua, MD, +15921515900, huakeqin@126.com
- Recruiting
Wuxi Obstetrics & Gynecology Hospital
Wuxi, Jiangsu, 241002
Yijuan Huang
Jian Gong, +86 13812074116, gongjianwx@126.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 II).
To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International Urogynecological AssociationInternational Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system) .
Read the detailed description
Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. And the date of surgeries carried is not restricted in the study period.
This is a study of real world. The researchers focus to investigate the incidence of complications in clinical practice.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic reconstructive surgery, mesh, native tissue, tape, complications, Category-time-site (CTS) coding
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and ratio of different postoperative complications
Calculate the frequency(reported in number of cases) and ratio(reported in percentage, %) of different complications reported from 27 tertiary hospitals in the past year or 3 years or 5 years, respectively.The complications occurred after pelvic reconstructive surgeries, especially mesh/native tissue related,are classified by IUGA-ICS CTS(category-time-site)coding system.
Measured: 1-year;3-year;5-year
Secondary outcomes (2)
The distribution of complications after each kind of pelvic reconstructive surgery
For each kind of surgery,the distribution of different postoperative complications, classified by the IUGA-ICS coding system, is expressed in frequency (reported in number of cases) and ratio(reported in percentage, %).
Measured: 1-year;3-year;5-year
The percentage of various pelvic reconstructive surgeries under the same complication classification coding.
Analyze and calculate the percentage of different surgical method when they present the complication with the same IUGA-ICS coding.
Measured: 1-year;3-year;5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 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.
- Other trials for Pelvic Organ ProlapseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,530 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, Chongqing Medical University, Shanxi Coal Central Hospital
- 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
- NCT03617211
- Sponsor's protocol ID
- JS-1566-2
- Status last verified
- Jun 2018
- First submitted
- 12 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 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 II).
- ClinicalTrials.gov ID
- NCT03617211
- Acronym / sponsor ID
- JS-1566-2
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic reconstructive surgery, mesh, native tissue, tape, complications, Category-time-site (CTS) coding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,530 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, Chongqing Medical University, Shanxi Coal Central Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 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.
To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International Urogynecological AssociationInternational Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system) .
Detailed description
Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. And the date of surgeries carried is not restricted in the study period.
This is a study of real world. The researchers focus to investigate the incidence of complications in clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at our participating hospitals but also from other hospital.And the date of surgeries carried is not restricted during the study period.
Key inclusion criteria (3 listed)
- 1) Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
- 2) Pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
- 3) Both primary and repeated pelvic surgery are included.
Key exclusion criteria (1 listed)
- If the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for "the same code complication in other 26 hospitals, she will be ruled out.
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 ratio of different postoperative complications
Time frame: 1-year;3-year;5-year
Calculate the frequency(reported in number of cases) and ratio(reported in percentage, %) of different complications reported from 27 tertiary hospitals in the past year or 3 years or 5 years, respectively.The complications occurred after pelvic reconstructive surgeries, especially mesh/native tissue related,are classified by IUGA-ICS CTS(category-time-site)coding system.
2 secondary outcomes
The distribution of complications after each kind of pelvic reconstructive surgery
Time frame: 1-year;3-year;5-year
The percentage of various pelvic reconstructive surgeries under the same complication classification coding.
Time frame: 1-year;3-year;5-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
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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 principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Peking Union Medical College Hospital at 5 sites 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 3 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 6 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 5 sites 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 (+86 13718879529, 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 ratio of different postoperative complications (time frame: 1-year;3-year;5-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2018.