- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07202442
- Original Trial
Robotic Emergency General Surgery Program
September 29, 2025 updated by: Centre Hospitalier Universitaire de Nice
Beginning of Robotic Emergency General Surgery Program at Nice University Hospital
Background Abdominal surgical emergencies account for 20-30% of visceral surgery procedures.
However, these emergencies are responsible for more than half of the morbidity in our discipline, with a surgical site infection rate four times higher than in elective surgery, and significantly higher rates of surgical revision and conversion (PMID: 34225343 and 27016997 and 27120712).
In cases where minimally invasive surgery is converted to laparotomy, patients are three times more likely to be admitted to critical care units (PMID: 39966134).
Visceral surgery currently represents the largest and fastest-growing discipline in robotic surgery.
Robotic management of emergency general surgery has been described in the literature for several years, particularly in the United States.
Robotic surgery allows a shift from open procedures to minimally invasive techniques or simplifies complex laparoscopic procedures.
Several literature reviews and meta-analyses report decreased laparotomy rates, reduced perioperative morbidity, and shorter average length of hospital stay (PMID: 38446451 and 38918109).
Abdominal surgical emergencies account for 20-30% of visceral surgery procedures.
However, these emergencies are responsible for more than half of the morbidity in our discipline, with a surgical site infection rate four times higher than in elective surgery, and significantly higher rates of surgical revision and conversion (PMID: 34225343 and 27016997 and 27120712).
In cases where minimally invasive surgery is converted to laparotomy, patients are three times more likely to be admitted to critical care units (PMID: 39966134).
Visceral surgery currently represents the largest and fastest-growing discipline in robotic surgery.
Robotic management of emergency general surgery has been described in the literature for several years, particularly in the United States.
Robotic surgery allows a shift from open procedures to minimally invasive techniques or simplifies complex laparoscopic procedures.
Several literature reviews and meta-analyses report decreased laparotomy rates, reduced perioperative morbidity, and shorter average length of hospital stay (PMID: 38446451 and 38918109).Primary Objective:To assess the implementation of a robotic surgery program for emergency visceral procedures (proof of feasibility in our university hospital).
Secondary Objectives: Reduce perioperative morbidity, Reduce the rate of laparotomy, Reduce the average length of hospital stay (LOS), Reduce postoperative admission to critical care, Reduce operative time.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Damien Massalou
- Phone Number: Massalou
- Email: massalou.d@chu-nice.fr
Study Locations
-
-
Alpes Maritimes
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Nice, Alpes Maritimes, France, 06000
- CHU de Nice
-
Contact:
- Damien Massalou
- Phone Number: + 33 04 92 03 22 63
- Email: massalou.d@chu-nice.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Emergency general surgery patients admitted to Nice University Hospital.
Description
Inclusion Criteria:
- Acute cholecystitis with predictors of intraoperative difficulty.
- Bowel obstruction requiring bowel resection (in presence of CT signs of visceral compromise: poor enhancement of bowel loops, pneumoperitoneum).
- Complicated acute diverticulitis with perforation and peritonitis.
- Penetrating abdominal trauma with hemodynamic stability requiring surgery (e.g., bowel resection-anastomosis).
- Right or left colectomy for other etiologies.
- Splenectomy in hemodynamically stable or embolized patients.
Exclusion Criteria:
- Hemodynamic instability.
- Uncomplicated acute appendicitis.
- Acute cholecystitis without predictors of intraoperative difficulty.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation of a robotic surgery program for emergency visceral procedures
Time Frame: Postoperative day 30
|
To assess the implementation of a robotic surgery program for emergency visceral procedures (proof of feasibility in our university hospital).The team will screen patients who will meet the inclusion criteria and the first score will be : were we able to purpose robotic approach fr the patient.
Then if we were able to do it, and if not, the reason why (OT nurse difficulty ?
technical issue ?
other ?).
|
Postoperative day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluating robotic general emergencies procedures (Change perioperative morbidity)
Time Frame: Postoperative day 30.
|
Clavien-Dindo Classification ( grade 1 to 5) vs an historical cohort
|
Postoperative day 30.
|
|
Evaluating robotic general emergencies procedures (Change the rate of laparotomy)
Time Frame: Postoperative day 30
|
Pourcentage vs historical data
|
Postoperative day 30
|
|
Evaluating robotic general emergencies procedures (Change the average length of hospital stay )
Time Frame: Postoperative day 30
|
(LOS)-(in days, vs historical data)
|
Postoperative day 30
|
|
Evaluating robotic general emergencies procedures (Change postoperative admission to critical care)
Time Frame: Postoperative day 30
|
Pourcentage vs historical data
|
Postoperative day 30
|
|
Evaluating robotic general emergencies procedures (Change operative time)
Time Frame: Postoperative day 30
|
In minutes, vs historical data
|
Postoperative day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
September 19, 2025
First Submitted That Met QC Criteria
September 29, 2025
First Posted (Estimated)
October 1, 2025
Study Record Updates
Last Update Posted (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 29, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 25Urgences01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.