Clinical Application of Laparo-endoscopic Single-site Surgery and Natural Orifice Transluminal Endoscopic in Gynecology (GLESS)

September 19, 2019 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  1. 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;
  2. Refuse to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion time
Time Frame: One time (intraoperative)
One time (intraoperative)
Success rate
Time Frame: One time (intraoperative)
One time (intraoperative)
Recurrence rate
Time Frame: 36 months
36 months
Conversion rate
Time Frame: One time (intraoperative)
One time (intraoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Chinese Medical Doctor Association
Chinese Obstetricians and Gynecologists Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLESS-NOTES.CN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer, Endometrial Cancer，Endometrial Lesion & Adnexal Lesion，Ectopic Pregnancy & Infertility，Pelvic Obstructive Disorder & Genital Tract Deformity

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