A Clinical Study Comparing the Effectiveness and Safety o... | NCT06817460

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

NCT06817460

Sponsor

The First Affiliated Hospital of Soochow University

Status

Completed

Last Update Posted

Feb 10, 2025Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Benign Tumor of Uterus
Surgical Approaches
Enhanced Recovery After Surgery

Interventions

tran-sumbilical laparoendoscopic single-site surgery
transvaginal natural orifice transluminal endoscopic surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Jul 30, 2024Actual

Completion Date

Jul 30, 2024Actual

First Submitted Date

Apr 21, 2024

First Submission Date that Met QC Criteria

Feb 5, 2025

First Posted Date

Feb 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2025

Last Update Posted Date

Feb 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
tran-sumbilical laparoendoscopic single-site surgery	Procedure	Different types of surgery	Observation group1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Operation time	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided