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

NCT06817460 | Completed

• 1 other identifier: 2024105
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hysterectomy; single-port; multi-port; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• Achievement of ERAS composite indexes within 24 hours after surgery

  Including: (1) postoperative liquid diet, (2) anal exhaust, (3) self-urination after catheter removal, (4) getting out of bed, (5) visual analogue scale (VAS) score ≤3

  (1) 6 hours after surgery; (2) 24 hours after surgery; (3) 48 hours after surgery

Secondary Outcomes (2)

• Operation time

  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

• intraoperative blood loss

  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

Study Arms (3)

Observation group1

EXPERIMENTAL

tran-sumbilical laparoendoscopic single-site surgery

Procedure: tran-sumbilical laparoendoscopic single-site surgery

Observation group2

EXPERIMENTAL

transvaginal natural orifice transluminal endoscopic surgery

Procedure: transvaginal natural orifice transluminal endoscopic surgery

control group

NO INTERVENTION

conventional three-port totaI laparoscopic hysterectomy

Interventions

tran-sumbilical laparoendoscopic single-site surgery PROCEDURE

Different types of surgery

Observation group1

transvaginal natural orifice transluminal endoscopic surgery PROCEDURE

Different types of surgery

Observation group2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: February 10, 2025
• Study Start: September 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (1)