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

February 5, 2025 updated by: The First Affiliated Hospital of Soochow University

A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Observation group1
tran-sumbilical laparoendoscopic single-site surgery
Procedure: tran-sumbilical laparoendoscopic single-site surgery
Different types of surgery
Experimental: Observation group2
transvaginal natural orifice transluminal endoscopic surgery
Procedure: transvaginal natural orifice transluminal endoscopic surgery
Different types of surgery
No Intervention: control group
conventional three-port totaI laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of ERAS composite indexes within 24 hours after surgery
Time Frame: (1) 6 hours after surgery; (2) 24 hours after surgery; (3) 48 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: 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
duration of surgery
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024105 (Other Grant/Funding Number: South-Eastern Norway Regional Health Authority)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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