Clinical trial NCT06817460: A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy
Official title: A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Tumor of Uterus
Surgical Approaches
Enhanced Recovery After Surgery
Keywords: hysterectomy
single-port
multi-port
enhanced recovery after surgery
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Operation time
timeFrame: The operation time is measured in minutes from the beginning of the skin (or vaginal) incision to the completion of the skin (or vaginal) suture
measure: intraoperative blood loss
timeFrame: The operation time is measured in minutes from the beginning of the skin (or vaginal) incision to the completion of the skin (or vaginal) suture
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: