臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 12, 2023
Last modified on	Jan. 12, 2023
Trial ID	jRCT1040220116

Scientific Title	Comparison of patients with gynecological disease for postoperative quality of life. (MIG-Q)
Public Title	Comparison of patients with gynecological disease for postoperative quality of life.

Contact for Scientific Queries	Name	Kondou Eiji
	Affiliation	Mie University Hospital
	Address	2-174 Edobashi, Tsu City, Mie Prefecture
	Telephone	+81-59-232-1111
	E-mail	mkubo@med.mie-u.ac.jp
Contact for Public Queries	Name	Kondou Eiji
	Affiliation	Mie University Hospital
	Address	2-174 Edobashi, Tsu City, Mie Prefecture
	Telephone	+81-59-232-1111
	E-mail	mkubo@med.mie-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 12, 2023
Actual date of first enrollment
Target sample size		800
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with uterine benign tumor, uterine cancer stage IA, IB, II, cervical cancer IA1, IA2, IB1, IIA1, or pelvic organ prolapse diagnosed by preoperative examination and undergoing pelvic organ prolapse surgery. Patients with a General Performance Status (P.S.) of 0 to 1. Patients aged 20 years and older. Patients with preserved function of major organs (bone marrow, heart, lungs, liver, kidney, etc.) who are eligible for surgery. (only in the case of malignant disease) Patients with no lymph node metastasis or metastasis to other intra-abdominal organs by contrast CT of the thorax and abdomen (simple CT or MRI of the thorax and abdomen for patients for whom contrast agents are not indicated). Patients who have received a thorough explanation of the study, who have given written consent of their own free will with full understanding, and who are able to cooperate with the pre- and postoperative questionnaires according to the schedule.
	Exclusion Criteria	Patients with bleeding disorders or coagulopathy that may not be controlled during surgery. Patients with active overlapping cancers. Patients who are pregnant or women who may be pregnant or lactating. Patients with severe cerebral aneurysm or glaucoma (for robotic surgery). Patients who, in the judgment of the Principal Investigator or Principal Investigator, will be unable to participate in the study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		benign uterine tumors,uterine cancer,cervical cancer ,pelvic organ prolapse
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		A Comparative Study of Pre- and Postoperative Quality of Life Surveys.
Secondary Outcome(s)		Examination of surgical information and perioperative complications.

Primary Sponsor	Eiji Kondou

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Research Ethics Review Committee of Mie University Hospital
Address	2-174 Edobashi, Tsu City, Mie Prefecture, Mie
Telephone	+81-59-231-5045
E-Mail	mie-crb@mo.medic.mie-u.ac.jp
Approval Status	Approval
Date of approval	May. 30, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none