LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY

NCT07383961 | Completed

• 1 other identifier: 25-005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic single-site cholecystectomy (RSSC) was first reported in children the PI from GSH in 2015, demonstrating the feasibility, safety, and short learning curve associated with RSSC. The primary advantages of RSSC identified in pediatric patients include superior cosmetic outcomes, reduced postoperative pain, and a shorter learning curve for surgeons compared to SILC. These benefits contribute to its growing acceptance among pediatric surgeons. However, despite clear short-term benefits, the need for evaluating long-term outcomes in pediatric populations remains unmet. There are currently no studies reporting long-term complications or cosmetic satisfaction following RSSC in pediatric patients. This study will attempt to evaluate the long term outcomes after RSSC and compare them with the current gold standard, multiport laparoscopic cholecystectomy, performed by the same surgeon at the same institution over a similar time frame.

Conditions

Robotic Surgical Procedure

Keywords

pediatric robotic surgery; single incision robotic surgery

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  24-60 months

Secondary Outcomes (1)

• cosmetic satisfaction

  24-60months

Study Arms (2)

laparoscopic multiport cholecystectomy

robotic single site cholecystectomy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients with gall bladder disease undergoing cholecystectomy

Sponsors & Collaborators

• Good Samaritan Hospital Medical Center, New York: lead

Study Sites (1)

Good Samaritan University Hospital

West Islip, New York, 11795, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Surgeon

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)