NCT06201221

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

December 9, 2023

Last Update Submit

December 29, 2023

Conditions

Benign Ovarian Tumors

Outcome Measures

Primary Outcomes (1)

  • Operation duration

    The time elapsed from the initial incision to final skin closure

    3 hours

Secondary Outcomes (2)

  • The Visual Analog Scale (VAS) score

    24 hours after surgery

  • 5-point Likert scale

    1 month and 1 year after surgery

Study Arms (2)

Single-port Laparoscopy group

Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents

Procedure: single-port laparoscopy surgery

Multiport Laparoscopy group

Multiport Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents

Procedure: multiport laparoscopy surgery

Interventions

single-port laparoscopy surgeryPROCEDURE

The two groups underwent different surgical procedures.

Single-port Laparoscopy group
multiport laparoscopy surgeryPROCEDURE

The two groups underwent different surgical procedures.

Multiport Laparoscopy group

Eligibility Criteria

Age1 Year - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Maternal and Child Health Hospital

Fuzhou, Fujian, 350001, China

Location

Study Officials

  • Pengming Sun, Ph.D

    Fujian Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 9, 2023

First Posted

January 11, 2024

Study Start

January 1, 2019

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

January 11, 2024

Record last verified: 2023-12

Locations

CN(1)