A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscop… (NCT06817460) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy
China300 participantsStarted 2023-09-01
Plain-language summary
To explore the achievement of ERAS composite indexes within 24 hours after the operation of transumbilical single-hole laparoscopic total hysterectomy, transvaginal laparoscopic total hysterectomy and porous laparoscopic total hysterectomy.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-60 females
* 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:
* asexual life history
* 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 o…
What they're measuring
1
Achievement of ERAS composite indexes within 24 hours after surgery
Timeframe: (1) 6 hours after surgery; (2) 24 hours after surgery; (3) 48 hours after surgery
Trial details
NCT IDNCT06817460
SponsorThe First Affiliated Hospital of Soochow University