Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096872
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Chinese Medical Doctor Association
Chinese Obstetricians and Gynecologists Association
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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. Eight gynecological conditions included were: cervical cancer, endometrial cancer, endometrial lesion, adnexal lesion, ectopic pregnancy, infertility, pelvic obstructive disorder, and genital tract deformity.

Condition or disease
Cervical Cancer, Endometrial Cancer,Endometrial Lesion & Adnexal Lesion,Ectopic Pregnancy & Infertility,Pelvic Obstructive Disorder & 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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 9000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Clinical Application of Laparo-endoscopic Single-site Surgery and Natural Orifice Transluminal Endoscopic in Gynecology- the Chinese National Registry
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Completion time [ Time Frame: One time (intraoperative) ]
  2. Success rate [ Time Frame: One time (intraoperative) ]
  3. Recurrence rate [ Time Frame: 36 months ]
  4. Conversion rate [ Time Frame: One time (intraoperative) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   GLESS- A National Gynecological laparoendoscopic single site surgery registry
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096872


Contacts
Layout table for location contacts
Contact: Liu Haiyuan 13811580852 haiyuanliu@163.com

Locations
Layout table for location information
China, Beijing
Gless-Notes Recruiting
Beijing, Beijing, China, 100000
Contact: Sun Dawei    13801112141    sundw1118@aliyun.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Chinese Medical Doctor Association
Chinese Obstetricians and Gynecologists Association

Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04096872     History of Changes
Other Study ID Numbers: GLESS-NOTES.CN
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Infertility
Pregnancy, Ectopic
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Genital Diseases, Male
Pregnancy Complications