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

NCT04096872 | Unknown DMC

• 1 other identifier: GLESS-NOTES.CN
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Completion time

  One time (intraoperative)

• Success rate

  One time (intraoperative)

• Recurrence rate

  36 months

• Conversion rate

  One time (intraoperative)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: GLESS- A National Gynecological laparoendoscopic single site surgery registry
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chinese Medical Doctor Association: collaborator
• Chinese Obstetricians and Gynecologists Association: collaborator

Study Sites (1)

Gless-Notes

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Liu Haiyuan

CONTACT

13811580852; haiyuanliu@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: November 1, 2017
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

CN (1)