Robotic Surgical ProcedureNCT07383961
LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY
An observational study of Robotic Surgical Procedure, run by Good Samaritan Hospital Medical Center, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Robotic Surgical Procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pediatric patients with gall bladder disease undergoing cholecystectomy
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan University Hospital
West Islip, New York, 11795
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Robotic Surgical Procedure
- Keywords
- pediatric robotic surgery, single incision robotic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic multiport cholecystectomy | Not described | |
| robotic single site cholecystectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Measured: 24-60 months
Secondary outcomes (1)
cosmetic satisfaction
Measured: 24-60months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Good Samaritan Hospital Medical Center, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinci Jones, Good Samaritan Hospital Medical Center, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383961
- Sponsor's protocol ID
- 25-005
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IRB has limited patient information access only to the investigators
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY
- ClinicalTrials.gov ID
- NCT07383961
- Acronym / sponsor ID
- 25-005
- Conditions
- Robotic Surgical Procedure
- Keywords
- pediatric robotic surgery, single incision robotic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Good Samaritan Hospital Medical Center, New YorkUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic multiport cholecystectomy | – | – |
| robotic single site cholecystectomy | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pediatric patients with gall bladder disease undergoing cholecystectomy
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative complications
Time frame: 24-60 months
1 secondary outcome
cosmetic satisfaction
Time frame: 24-60months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. IRB has limited patient information access only to the investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgical Procedure, run by Good Samaritan Hospital Medical Center, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 24-60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.