Cervical Cancer, Endometrial Cancer，Endometrial Lesion & Adnexal Lesion，Ectopic Pregnancy & Infertility，Pelvic Obstructive Disorder & Genital Tract DeformityGLESSNCT04096872
Clinical Application of Laparo-endoscopic Single-site Surgery and Natural Orifice Transluminal Endoscopic in Gynecology
An observational study of Cervical Cancer, Endometrial Cancer，Endometrial Lesion & Adnexal Lesion，Ectopic Pregnancy & Infertility，Pelvic Obstructive Disorder & Genital Tract Deformity, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The GLESS registry is a prospective multi-center observational registry. Data from the time of patient admission, operation, discharge, and follow-up will be collected for this registry. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer，Endometrial Lesion & Adnexal Lesion，Ectopic Pregnancy & Infertility，Pelvic Obstructive Disorder & Genital Tract Deformity
- How many people
- 9,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 31 Oct 2022
- How long will I take part?
- 36 Months
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Types of conditions included in the GLESS registry. Malignancies:Cervical cancer, Endometrial cancer Benign lesion：Endometrial lesion \& Adnexal lesion Reproductive conditions：Ectopic pregnancy \& infertility Structural abnormalities/lesions：Pelvic obstructive disorder \& Genital tract deformity
Who may be able to join
- Adults over 18 years of age, that have the conditions eligibility with severity meeting within the surgical indications of the 2017 Chinese expert consensus on GLESS. Eligibility will be confirmed by the gynecological surgeon who are treating at each location. Patients are recruited after admission and prior to the operation.
Who cannot join
- Acute infection stage, preoperative deep venous thrombosis or hypercoagulability, fasting blood sugar > 11.1 mmol/L, blood pressure > 160/100 mmHg, liver and kidney dysfunction, mental illness and other surgical contraindications;
- Refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gless-Notes
Beijing, Beijing Municipality, 100000
Sun Dawei, 13801112141, sundw1118@aliyun.com
About this study
Official title: Clinical Application of Laparo-endoscopic Single-site Surgery and Natural Orifice Transluminal Endoscopic in Gynecology- the Chinese National Registry
The GLESS registry is a prospective multi-center observational registry. Data from the time of patient admission, operation, discharge, and follow-up will be collected for this registry. Eight gynecological conditions included were: cervical cancer, endometrial cancer, endometrial lesion, adnexal lesion, ectopic pregnancy, infertility, pelvic obstructive disorder, and genital tract deformity.
Read the detailed description
Founding of the group. In June 2016 with the support of the Chinese Medical Doctor's Association and Chinese OBGYN Association, the not-for-profit GLESS (including Notes) Working Group was founded. The national Working Group is tasked with creating and maintaining the Prospective GLESS data registry, standardizing LESS surgeon training, creating best practices and guidelines. The Working Group aims to extend to all 35 provinces in Mainland China covering over 200 hospitals nationwide.
The GLESS Working Group published an expert consensus in 2017 on the indications and contraindications of the surgery. The GLESS registry is a prospective observational case-only database. Literature has cases, outcomes are positive and promising, but there lacks a systematic and large scale multi-center registry to provide data driven evidence for best practices.
The goal for the group (evidence level- can we achieve level 1, Canada task force). Research, share experiences to identify indications, standard surgical practices, understand outcomes/observations. Provide empirical evidence for GLESS and Notes surgical indications and complications. Provide empirical evidence for advancing procedures, expanding surgical indications (e.g. can GLESS be performed on cervical cancer?), what is the reliability, standard procedures for training Create best practices for 1)Identifying suitable clinical indications- expanding 2)surgical techniques (entry, port placement, trochar, retraction, suture, ligation) \& selecting surgical instrumentation3)Identifying, minimizing, and handling complications.
4)Carrying out optimal perioperative and postoperative care 5)Creating a safe and comfortable experience in terms of cosmesis, pain, and overall experience 6)Understand how various techniques can impact short/mid/long term for patients Outcomes will include a National effort to coordinate followup to create the largest/most reliable data set for understanding prognostic outcomes related to GLESS. With accumulated data/big data techniques develop comprehensive short term and long term scoring systems for colleagues and patients around the world. Create standard nomenclature for easier collaboration and communication between gynecologists Note on NOTES? Why we include it here. Yes, notes is a natural progression from LESS. With the orifice being the vagina. We believe understanding the risks/rewards of such a procedure can make the transition from an umbilical to vaginal entry point easy.
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion time
Measured: One time (intraoperative)
Success rate
Measured: One time (intraoperative)
Recurrence rate
Measured: 36 months
Conversion rate
Measured: One time (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Nov 2017
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer, Endometrial Cancer，Endometrial Lesion & Adnexal Lesion，Ectopic Pregnancy & Infertility，Pelvic Obstructive Disorder & Genital Tract DeformityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Doctor Association, Chinese Obstetricians and Gynecologists Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096872
- Sponsor's protocol ID
- GLESS-NOTES.CN
- Acronym
- GLESS
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Laparo-endoscopic Single-site Surgery and Natural Orifice Transluminal Endoscopic in Gynecology- the Chinese National Registry
- ClinicalTrials.gov ID
- NCT04096872
- Acronym / sponsor ID
- GLESS / GLESS-NOTES.CN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese Medical Doctor Association, Chinese Obstetricians and Gynecologists Association
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 20 Sep 2019 (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.
The GLESS registry is a prospective multi-center observational registry. Data from the time of patient admission, operation, discharge, and follow-up will be collected for this registry. Eight gynecological conditions included were: cervical cancer, endometrial cancer, endometrial lesion, adnexal lesion, ectopic pregnancy, infertility, pelvic obstructive disorder, and genital tract deformity.
Detailed description
Founding of the group. In June 2016 with the support of the Chinese Medical Doctor's Association and Chinese OBGYN Association, the not-for-profit GLESS (including Notes) Working Group was founded. The national Working Group is tasked with creating and maintaining the Prospective GLESS data registry, standardizing LESS surgeon training, creating best practices and guidelines. The Working Group aims to extend to all 35 provinces in Mainland China covering over 200 hospitals nationwide.
The GLESS Working Group published an expert consensus in 2017 on the indications and contraindications of the surgery. The GLESS registry is a prospective observational case-only database. Literature has cases, outcomes are positive and promising, but there lacks a systematic and large scale multi-center registry to provide data driven evidence for best practices.
The goal for the group (evidence level- can we achieve level 1, Canada task force). Research, share experiences to identify indications, standard surgical practices, understand outcomes/observations. Provide empirical evidence for GLESS and Notes surgical indications and complications. Provide empirical evidence for advancing procedures, expanding surgical indications (e.g. can GLESS be performed on cervical cancer?), what is the reliability, standard procedures for training Create best practices for 1)Identifying suitable clinical indications- expanding 2)surgical techniques (entry, port placement, trochar, retraction, suture, ligation) \& selecting surgical instrumentation3)Identifying, minimizing, and handling complications.
4)Carrying out optimal perioperative and postoperative care 5)Creating a safe and comfortable experience in terms of cosmesis, pain, and overall experience 6)Understand how various techniques can impact short/mid/long term for patients Outcomes will include a National effort to coordinate followup to create the largest/most reliable data set for understanding prognostic outcomes related to GLESS. With accumulated data/big data techniques develop comprehensive short term and long term scoring systems for colleagues and patients around the world. Create standard nomenclature for easier collaboration and communication between gynecologists Note on NOTES? Why we include it here. Yes, notes is a natural progression from LESS. With the orifice being the vagina. We believe understanding the risks/rewards of such a procedure can make the transition from an umbilical to vaginal entry point easy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Types of conditions included in the GLESS registry. Malignancies:Cervical cancer, Endometrial cancer Benign lesion：Endometrial lesion \& Adnexal lesion Reproductive conditions：Ectopic pregnancy \& infertility Structural abnormalities/lesions：Pelvic obstructive disorder \& Genital tract deformity
Key inclusion criteria (1 listed)
- Adults over 18 years of age, that have the conditions eligibility with severity meeting within the surgical indications of the 2017 Chinese expert consensus on GLESS. Eligibility will be confirmed by the gynecological surgeon who are treating at each location. Patients are recruited after admission and prior to the operation.
Key exclusion criteria (2 listed)
- Acute infection stage, preoperative deep venous thrombosis or hypercoagulability, fasting blood sugar > 11.1 mmol/L, blood pressure > 160/100 mmHg, liver and kidney dysfunction, mental illness and other surgical contraindications;
- Refuse to sign informed consent.
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
Completion time
Time frame: One time (intraoperative)
Success rate
Time frame: One time (intraoperative)
Recurrence rate
Time frame: 36 months
Conversion rate
Time frame: One time (intraoperative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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.
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 Cervical Cancer, Endometrial Cancer，Endometrial Lesion & Adnexal Lesion，Ectopic Pregnancy & Infertility，Pelvic Obstructive Disorder & Genital Tract Deformity, 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 1 inclusion and 2 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 20 Sep 2019. 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 Liu Haiyuan (13811580852, haiyuanliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion time (time frame: One time (intraoperative)). The study lists 4 primary outcomes in all. 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 20 Sep 2019.