Single-port Laparoscopy in Children and Adolescents

December 29, 2023 updated by: Yebin Feng, Fujian Maternity and Child Health Hospital

Advantages of Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents: A Multicenter Retrospective Study

To compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with BOT in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

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
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Maternal and Child Health Hospital

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients aged ≤18 years and pathologically diagnosed with BOT were collected from the electronic medical records of six gynecological oncology medical centers in Fujian, China between January 2019 and January 2023.

Description

Inclusion Criteria:

  • Patients ≤18 years old
  • Postoperative pathological diagnosis confirmed benign ovarian tumor
  • Multi-hole laparoscopic or single-hole laparoscopic surgery
  • Medical records and pathological data were complete and available

Exclusion Criteria:

  • Patients with malignant pathological diagnosis
  • Patients undergoing open surgery
  • Incomplete medical records or pathological data

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
Single-port Laparoscopy group
Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents
Procedure: single-port laparoscopy surgery
The two groups underwent different surgical procedures.
Multiport Laparoscopy group
Multiport Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents
Procedure: multiport laparoscopy surgery
The two groups underwent different surgical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation duration
Time Frame: 3 hours
The time elapsed from the initial incision to final skin closure
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS) score
Time Frame: 24 hours after surgery
Postoperative pain was evaluated by The Visual Analog Scale (VAS) score. The scale has a maximum score of 10 and a minimum score of 0, with higher scores meaning worse outcomes
24 hours after surgery
5-point Likert scale
Time Frame: 1 month and 1 year after surgery
5-point Likert scale to assess the satisfaction at 1 month and 1 year post-operatively. The scale has a maximum score of 5 and a minimum score of 1, with higher scores meaning better outcomes
1 month and 1 year after surgery

Collaborators and Investigators

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

Sponsor

Fujian Maternity and Child Health Hospital

Collaborators

First Affiliated Hospital of Fujian Medical University
Quanzhou First Hospital Affiliated to Fujian Medical University

Investigators

  • Principal Investigator: Pengming Sun, Ph.D, Fujian Maternity and Child Health Hospital

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, 2019

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FujianMCHH-Tong01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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