Robotic Emergency General Surgery Program

NCT ID: NCT07202442

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Emergency General Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de NICE

Nice, Alpes Maritimes, France

Site Status

Countries

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France

Central Contacts

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Damien Massalou

Role: CONTACT

Facility Contacts

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Damien Massalou

Role: primary

04 92 03 22 63 ext. + 33

Other Identifiers

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25Urgences01

Identifier Type: -

Identifier Source: org_study_id

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