Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches

September 14, 2023 updated by: Yingchun Ma
Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

173

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
    • Shandong
      • Jinan, Shandong, China
        • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

nothing

Description

Inclusion Criteria:

Preoperative consideration was for benign ovarian tumors requiring surgical treatment.

Exclusion Criteria:

  • (1) Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. (2) Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. (3) Pregnancy status. (4) Postoperative follow-up is not convenient and lost visitors.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
multi-port laparoscopic surgery
Procedure: operation ways
nothing
transumbilical laparoendoscopic single-site surgery
Procedure: operation ways
nothing
vaginal natural orifice transluminal endoscopic surgery
Procedure: operation ways
nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peroperative bleeding
Time Frame: during the operation time
peroperative bleeding
during the operation time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative exhaust time
Time Frame: within 3 days after operation
postoperative exhaust time
within 3 days after operation

Collaborators and Investigators

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

Sponsor

Yingchun Ma

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)

January 1, 2017

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V50KFC

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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