Single-port Laparoscopy in Children and Adolescents

Completed

• Conditions: Benign Ovarian Tumors
• Interventions: Procedure: single-port laparoscopy surgery; Procedure: multiport laparoscopy surgery

• Registration Number: NCT06201221
• Lead Sponsor: Fujian Maternity and Child Health Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-01-01
• Status Verified: 2023-12
• Study Completion: 2023-12-01
• Study First Submitted: 2023-12-09
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-port Laparoscopy group	single-port laparoscopy surgery	Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents
Multiport Laparoscopy group	multiport laparoscopy surgery	Multiport Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents

Primary Outcome Measures

Name	Time	Method
Operation duration	3 hours	The time elapsed from the initial incision to final skin closure

Secondary Outcome Measures

Name	Time	Method
The Visual Analog Scale (VAS) score	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
5-point Likert scale	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

Trial Locations

Locations (1)

Fujian Maternal and Child Health Hospital; 🇨🇳 Fuzhou, Fujian, China