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

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

— GLESS  

Official title:

Clinical Application of Laparo-endoscopic Single-site Surgery and Natural Orifice Transluminal Endoscopic in Gynecology- the Chinese National Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096872
• Other study ID #: GLESS-NOTES.CN
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2019
• Source: Peking Union Medical College Hospital
• Contact: Liu Haiyuan
• Phone: 13811580852
• Email: haiyuanliu[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer, Endometrial Cancer,Endometrial Lesion & Adnexal Lesion,Ectopic Pregnancy & Infertility,Pelvic Obstructive Disorder & Genital Tract Deformity
• Endometrial Neoplasms
• Infertility
• Pregnancy, Ectopic

Locations

Country	Name	City	State
China	Gless-Notes	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Chinese Medical Doctor Association, Chinese Obstetricians and Gynecologists Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion time		One time (intraoperative)
Primary	Success rate		One time (intraoperative)
Primary	Recurrence rate		36 months
Primary	Conversion rate		One time (intraoperative)