Emergency General SurgeryNCT07202442
Robotic Emergency General Surgery Program
An observational study of Emergency General Surgery, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency General Surgery
- What is being tested?
- Emergency General surgery patients with robotic approach for the surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency general surgery patients admitted to Nice University Hospital.
Who may be able to join
- 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.
Who cannot join
- Hemodynamic instability.
- Uncomplicated acute appendicitis.
- Acute cholecystitis without predictors of intraoperative difficulty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de NICE
Nice, Alpes Maritimes, 06000
Damien Massalou, 04 92 03 22 63 ext. + 33, massalou.d@chu-nice.fr
About this study
Official title: 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.
- Conditions
- Emergency General Surgery
- Being tested
- Emergency General surgery patients with robotic approach for the surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency General surgery patients with robotic approach for the surgeryProcedure or surgery
vPrimary Endpoint: The proportion of procedures performed robotically versus laparoscopically or via laparotomy for selected indications. Secondary Endpoints: A 5% change in perioperative morbidity, laparotomy rate, LOS, critical care admission rate, and operative time. Included Pathologies (for patients eligible for laparoscopy) : 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of a robotic surgery program for emergency visceral procedures
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 ?).
Measured: Postoperative day 30
Secondary outcomes (5)
Evaluating robotic general emergencies procedures (Change perioperative morbidity)
Clavien-Dindo Classification ( grade 1 to 5) vs an historical cohort
Measured: Postoperative day 30.
Evaluating robotic general emergencies procedures (Change the rate of laparotomy)
Pourcentage vs historical data
Measured: Postoperative day 30
Evaluating robotic general emergencies procedures (Change the average length of hospital stay )
(LOS)-(in days, vs historical data)
Measured: Postoperative day 30
Evaluating robotic general emergencies procedures (Change postoperative admission to critical care)
Pourcentage vs historical data
Measured: Postoperative day 30
Evaluating robotic general emergencies procedures (Change operative time)
In minutes, vs historical data
Measured: Postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency General SurgeryStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202442
- Sponsor's protocol ID
- 25Urgences01
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beginning of Robotic Emergency General Surgery Program at Nice University Hospital
- ClinicalTrials.gov ID
- NCT07202442
- Acronym / sponsor ID
- 25Urgences01
- Conditions
- Emergency General Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency general surgery patients admitted to Nice University Hospital.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Hemodynamic instability.
- Uncomplicated acute appendicitis.
- Acute cholecystitis without predictors of intraoperative difficulty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency General surgery patients with robotic approach for the surgeryvPrimary Endpoint: The proportion of procedures performed robotically versus laparoscopically or via laparotomy for selected indications. Secondary Endpoints: A 5% change in perioperative morbidity, laparotomy rate, LOS, critical care admission rate, and operative time. Included Pathologies (for patients eligible for laparoscopy) : 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. | Procedure or surgery | – |
Primary outcome
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 ?).
5 secondary outcomes
Evaluating robotic general emergencies procedures (Change perioperative morbidity)
Time frame: Postoperative day 30.
Evaluating robotic general emergencies procedures (Change the rate of laparotomy)
Time frame: Postoperative day 30
Evaluating robotic general emergencies procedures (Change the average length of hospital stay )
Time frame: Postoperative day 30
Evaluating robotic general emergencies procedures (Change postoperative admission to critical care)
Time frame: Postoperative day 30
Evaluating robotic general emergencies procedures (Change operative time)
Time frame: Postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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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.
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 Emergency General Surgery, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Oct 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien Massalou (Massalou, massalou.d@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of a robotic surgery program for emergency visceral procedures (time frame: Postoperative day 30). 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 1 Oct 2025.