Robotic Emergency General Surgery Program

NCT07202442 | Not Yet Recruiting

• 1 other identifier: 25Urgences01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

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 ?).

  Postoperative day 30

Secondary Outcomes (5)

• Evaluating robotic general emergencies procedures (Change perioperative morbidity)

  Postoperative day 30.

• Evaluating robotic general emergencies procedures (Change the rate of laparotomy)

  Postoperative day 30

• Evaluating robotic general emergencies procedures (Change the average length of hospital stay )

  Postoperative day 30

• Evaluating robotic general emergencies procedures (Change postoperative admission to critical care)

  Postoperative day 30

• Evaluating robotic general emergencies procedures (Change operative time)

  Postoperative day 30

Interventions

Emergency General surgery patients with robotic approach for the surgery PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency general surgery patients admitted to Nice University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamic instability.
• Uncomplicated acute appendicitis.
• Acute cholecystitis without predictors of intraoperative difficulty.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Location

Central Study Contacts

Damien Massalou

CONTACT

Massalou; massalou.d@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 1, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

FR (1)