LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY

Conditions

• Robotic Surgical Procedure

Eligibility Criteria

Sex

ALL

Age

15 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Aug 1, 2025

Status verified

Jan 2026

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

150 participants (actual)

Arms

• Arm: laparoscopic multiport cholecystectomy
• Arm: robotic single site cholecystectomy

Primary Outcome Measure

postoperative complications [ Time Frame: 24-60 months ]

Locations (1)

Find similar trials in West Islip, NY

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  PHASE4 · Not Yet Recruiting · Baylor College of Medicine · Houston, Texas