Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:47 AM
Study NCT ID:
NCT07383961
Status:
COMPLETED
Last Update Posted:
2026-02-03
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY
Sponsor:
Good Samaritan Hospital Medical Center, New York
Organization:
Study Overview
Official Title:
LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Robotic single-site cholecystectomy (RSSC) was first reported in children by Jones (2015), who conducted a retrospective review demonstrating the feasibility, safety, and short learning curve associated with RSSC compared to single-incision laparoscopic cholecystectomy (SILC) in pediatric patients, which has been proven to be technically challenging \[1\]. Subsequently, Esposito et al. further supported these findings, showing similar safety and effectiveness of RSSC in pediatrics over a 6-year period \[2\]. Rothenberg et al. compared robotic-assisted cholecystectomy (RC) to laparoscopic cholecystectomy (LC) in children, highlighting no significant differences in immediate postoperative complications, opioid utilization, or hospital readmissions but identifying higher costs associated with RC \[3\]. Kulaylat et al. similarly reported longer operative times (98 vs 79 minutes) and higher overall costs ($15,519 vs $11,197) for robotic procedures compared to laparoscopic ones, though postoperative complications and length of stay (LOS) were comparable \[4\].
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.
In adult populations, short-term studies comparing RSSC and multiport laparoscopic cholecystectomy (MLC) revealed comparable hospital stay, complication rates, seroma formation, and infection rates \[5\]. Hagen et al. demonstrated increased costs and higher reoperation rates for hernias with RSSC compared to MLC in adults \[6\]. Lurje et al. evaluated short-term cosmetic outcomes, confirming patient satisfaction with robotic surgery in adults, but no pediatric data was provided \[7\].
In pediatric patients, short-term follow-ups primarily emphasized operative safety, operative time, hospital stay, and immediate postoperative complications, generally showing equivalence between RC and LC with the exception of higher costs for RC \[3,4\].
Long-term outcomes in adult populations show conflicting reports. Marks et al. demonstrated high patient-reported cosmetic satisfaction scores at 8-year follow-up favoring SILC over conventional laparoscopic surgery \[8\]. Conversely, Christoffersen et al. found that most incisional hernias following SILC occurred within two years post-surgery, suggesting the need for continued monitoring \[9\]. Recent adult cohort studies reported comparable operative times and hospital stays between robotic and laparoscopic procedures, but with slightly higher costs associated with robotic surgery \[10\].
The current literature underscores significant gaps in the long-term follow-up of pediatric RSSC outcomes. To date, comprehensive evaluation of long-term hernia rates, cosmetic satisfaction, and patient-reported outcomes in children undergoing RSSC is lacking. This study aims to fill this gap by providing essential long-term data on RSSC outcomes, affirming its durability and superiority as an alternative to MLC.
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.
In adult populations, short-term studies comparing RSSC and multiport laparoscopic cholecystectomy (MLC) revealed comparable hospital stay, complication rates, seroma formation, and infection rates \[5\]. Hagen et al. demonstrated increased costs and higher reoperation rates for hernias with RSSC compared to MLC in adults \[6\]. Lurje et al. evaluated short-term cosmetic outcomes, confirming patient satisfaction with robotic surgery in adults, but no pediatric data was provided \[7\].
In pediatric patients, short-term follow-ups primarily emphasized operative safety, operative time, hospital stay, and immediate postoperative complications, generally showing equivalence between RC and LC with the exception of higher costs for RC \[3,4\].
Long-term outcomes in adult populations show conflicting reports. Marks et al. demonstrated high patient-reported cosmetic satisfaction scores at 8-year follow-up favoring SILC over conventional laparoscopic surgery \[8\]. Conversely, Christoffersen et al. found that most incisional hernias following SILC occurred within two years post-surgery, suggesting the need for continued monitoring \[9\]. Recent adult cohort studies reported comparable operative times and hospital stays between robotic and laparoscopic procedures, but with slightly higher costs associated with robotic surgery \[10\].
The current literature underscores significant gaps in the long-term follow-up of pediatric RSSC outcomes. To date, comprehensive evaluation of long-term hernia rates, cosmetic satisfaction, and patient-reported outcomes in children undergoing RSSC is lacking. This study aims to fill this gap by providing essential long-term data on RSSC outcomes, affirming its durability and superiority as an alternative to MLC.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: