A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy
NCT ID: NCT06817460
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2023-09-01
2024-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Observation group1
tran-sumbilical laparoendoscopic single-site surgery
tran-sumbilical laparoendoscopic single-site surgery
Different types of surgery
Observation group2
transvaginal natural orifice transluminal endoscopic surgery
transvaginal natural orifice transluminal endoscopic surgery
Different types of surgery
control group
conventional three-port totaI laparoscopic hysterectomy
No interventions assigned to this group
Interventions
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tran-sumbilical laparoendoscopic single-site surgery
Different types of surgery
transvaginal natural orifice transluminal endoscopic surgery
Different types of surgery
Eligibility Criteria
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Inclusion Criteria
* Total hysterectomy indications (uterine fibroids, adenomyosis, cervical precancerous lesions, endometrial dysplasia, cervical carcinoma in situ), total hysterectomy is planned
* The patients who participated in the study recognized three surgical paths and were willing to accept any of the three at random
* Be able to understand the research program and voluntarily participate in the research, and sign the informed consent
* Good compliance, able to cooperate with and provide corresponding clinical information
* Complete imaging and pathological clinical data;
* General condition: ECOG≤1; 0 The activity capacity is completely normal, and there is no difference between the activity capacity and that before the onset of the disease; 1 Can move about freely and engage in light physical activity, including general household or office work, but cannot engage in heavy physical activity.
Exclusion Criteria
* The cyst needs to be removed at the same time or there are other vulvar, vaginal, appendix and other lesions, and surgical intervention is required at the same time
* Malignant tumors or highly suspected malignant tumors
* History of two or more pelvic surgeries, severe pelvic adhesions(triad examination suspected rectal endometriosis, or poor intrauterine mobility)
* History of peritoneal dialysis, pelvic radiotherapy, and previous history of pelvic laparoscopic tuberculosis
* the uterus is greater than 3 months of pregnancy or the maximum meridian of the uterus is greater than 12cm according to ultrasound (either of the two conditions can be excluded)
* Diabetic patients with unsatisfactory blood sugar control
* BMI\>30Kg/m2
* History of severe mental illness and brain dysfunction
* A history of drug abuse or use
* Patients with poor compliance or who are too far away for adequate follow-up
18 Years
60 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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2024105
Identifier Type: -
Identifier Source: org_study_id
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