Comparison of patients with gynecological disease for postoperative quality of life.

JRCT ID: jRCT1040220116

Registered date:12/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: benign uterine tumors,uterine cancer,cervical cancer ,pelvic organ prolapse
• Date of first enrollment: 12/01/2023
• Target sample size: 800
• Study type: Observational

Outcome(s)

• Primary Outcome: A Comparative Study of Pre- and Postoperative Quality of Life Surveys.
• Secondary Outcome: Examination of surgical information and perioperative complications.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kondou Eiji