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Not yet recruiting NCT07202442

Robotic Emergency General Surgery Program

Observational Emergency General Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emergency General surgery patients with robotic approach for the surgery.
Who it may be relevant to
Registry conditions: Emergency General Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Beginning of Robotic Emergency General Surgery Program at Nice University Hospital

Overview

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.

Interventions

  • Procedure Emergency General surgery patients with robotic approach for the 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 en

Primary outcome measures

  • Implementation of a robotic surgery program for emergency visceral procedures [Time frame: Postoperative day 30]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de NICE — Nice

Identifiers

NCT: NCT07202442 · 25Urgences01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗