A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy

Soochow University

Status: Completed

Conditions: Benign Tumor of Uterus; Surgical Approaches; Enhanced Recovery After Surgery

Treatments: Procedure: tran-sumbilical laparoendoscopic single-site surgery; Procedure: transvaginal natural orifice transluminal endoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06817460

2024105 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.To explore the differences of operation time, intraoperative blood loss, intraoperative conversion mode and postoperative complication rate of three surgical paths: transumbilical single-hole laparoscopic total hysterectomy, transcolposcopic total hysterectomy and porous laparoscopic total hysterectomy.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Observation group1

Experimental group

Description:

tran-sumbilical laparoendoscopic single-site surgery

Treatment:

Procedure: tran-sumbilical laparoendoscopic single-site surgery

Observation group2

Experimental group

Description:

transvaginal natural orifice transluminal endoscopic surgery

Treatment:

Procedure: transvaginal natural orifice transluminal endoscopic surgery

control group

No Intervention group

Description:

conventional three-port totaI laparoscopic hysterectomy