Robotic Emergency General Surgery Program
ConditionEmergency General Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Hemodynamic instability.
Uncomplicated acute appendicitis.
Acute cholecystitis without predictors of intraoperative difficulty.
Trial population
Emergency general surgery patients admitted to Nice University Hospital.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Emergency General surgery patients with robotic approach for the surgery
Procedure/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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 ?).
Time frame
Postoperative day 30Secondary outcomes
1
Evaluating robotic general emergencies procedures (Change perioperative morbidity)
Clavien-Dindo Classification ( grade 1 to 5) vs an historical cohort
Time frame
Postoperative day 30.2
Evaluating robotic general emergencies procedures (Change the rate of laparotomy)
Pourcentage vs historical data
Time frame
Postoperative day 303
Evaluating robotic general emergencies procedures (Change the average length of hospital stay )
(LOS)-(in days, vs historical data)
Time frame
Postoperative day 304
Evaluating robotic general emergencies procedures (Change postoperative admission to critical care)
Pourcentage vs historical data
Time frame
Postoperative day 30Sponsors and contacts
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Source ClinicalTrials.gov
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