Studies

Interventional Recruiting

NCT05691348 on ClinicalTrials.gov

Same Day Ambulatory Appendectomy (SAMBA)

  • Sponsor: Centre Hospitalier Universitaire de Nice
  • Enrollment: 1400 (Estimated)
  • Study start: 2023-07-17 (Actual)
  • Primary completion: 2028-01-17 (Estimated)
  • Study completion: 2028-01-17 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:

1. Optimization of the care pathway, reducing the length of stay in hospital (a major issue in the context of the COVID-19 (coronavirus disease) pandemic) liberating patient beds and staff, and reducing the risk of nosocomial exposure.
2. Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.
3. Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.
4. Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.

Conditions

  • Appendicitis

Intervention / Treatment

  • Procedure: Ambulatory appendectomy
  • Procedure: Conventional appendectomy

Primary Outcome Measures

  • To demonstrate that outpatient care, compared with conventional care, in selected patients with acute uncomplicated appendicitis operated by laparoscopy, is non-inferior in terms of overall morbi-mortality on the 30th postoperative day. (30 days post surgery)
    Morbi-mortality will be assessed by classifying post-operative complications according to Clavien-Dindo classification. It will be compared between both groups ("ambulatory pathway" versus "conventional hospitalization" CONV) on the 30th postoperative day. The Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). Complications that potentially lead to long-lasting disability after discharge (e.g.: paralysis of a vocal cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a long-term follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.

Countries

France, Reunion

Locations and Investigators

  • Hôpitaux Pédiatriques de Nice CHU - Lenval, Nice, France (Not yet recruiting)
    • Jean BREAUD
    • Jean BREAUD (Principal Investigator)
  • CHU de Nice, Nice, France (Recruiting)
    • Damien MASSALOU
    • Damien MASSALOU (Principal Investigator)
  • CHU de Bordeaux, Bordeaux, France (Not yet recruiting)
    • Vincent DUBUISSON
    • Vincent DUBUISSON (Principal Investigator)
  • CH de Troyes, Troyes, France (Not yet recruiting)
    • Geoffrey LEDOUX
    • Geoffrey LEDOUX (Principal Investigator)
  • CHU Grenoble Alpes, La Tronche, France (Recruiting)
    • Julio ABBA
    • Julio ABBA (Principal Investigator)
  • Hôpital Edouard HERRIOT, Lyon, France (Recruiting)
    • Olivier MONNEUSE
    • Olivier MONNEUSE (Principal Investigator)
  • CHU de Saint-Etienne - Hôpital Nord, Saint-Priest-en-Jarez, France (Recruiting)
    • Karine ABBOUD
    • Karine ABBOUD (Principal Investigator)
  • CH de Voiron, Voiron, France (Recruiting)
    • Romain RIBOUD
    • Romain RIBOUD (Principal Investigator)
  • APHM Hôpital Nord, Marseille, France (Recruiting)
    • Laura BEYER
    • Laura BEYER (Principal Investigator)
  • CHU Minjo, Besançon, France (Not yet recruiting)
    • Célia TURCO
    • Célia TURCO (Principal Investigator)
  • CHU de Rennes, Rennes, France (Not yet recruiting)
    • Aude MERDRIGNAC
    • Aude MERDRIGNAC (Principal Investigator)
  • Hôpital Robert Debré - CHU de Reims, Reims, France (Recruiting)
    • Rami RHAIEM
    • Rami RHAIEM (Principal Investigator)
  • Hôpital Beaujon (APHP), Clichy, France (Not yet recruiting)
    • LACAZE Laurence
    • Laurence LACAZE (Principal Investigator)
  • CHU Amiens-Picardie, Amiens, France (Recruiting)
    • Elodie HARAUX
    • Elodie HARAUX (Principal Investigator)
  • Clinique de Saint-Omer, Blendecques, France (Not yet recruiting)
    • André DABROWSKI
    • André DABROWSKI (Principal Investigator)
  • HIA Percy, Clamart, France (Not yet recruiting)
    • Emmanuel HORNEZ
    • Emmanuel HORNEZ (Principal Investigator)
  • CHU de Tours, Tours, France (Not yet recruiting)
    • Anne LE TOUZE
    • Anne LE TOUZE (Principal Investigator)
  • CHU de Reims, Reims, France (Not yet recruiting)
    • Nadia BOUDAOUD
    • Nadia BOUDAOUD (Principal Investigator)
  • CH de Dax, Dax, France (Recruiting)
    • Benjamin BLANC
    • Benjamin BLANC (Principal Investigator)
  • CH de Mont de Marsan, Mont-de-Marsan, France (Recruiting)
    • Rémy CHEVALIER
    • Rémy CHEVALIER (Principal Investigator)
  • Hôpital Cochin APHP, Paris, France (Not yet recruiting)
  • CHU d'Angers, Angers, France (Recruiting)
    • Emilie LERMITE
    • elermite@chu-angers.fr
    • Emilie LERMITE (Principal Investigator)
  • Hôpital d'Instruction des armées Laveran, Marseille, France (Recruiting)
    • Yvain GOUDARD
    • Yvain GOUDARD (Principal Investigator)
  • Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon, Toulon, France (Recruiting)
    • Stéphane BOURGOUIN
    • Stéphane BOURGOUIN (Principal Investigator)
  • Clinique du Val d'Ouest, Écully, France (Not yet recruiting)
    • Philippe GUILLEM
    • Philippe GUILLEM (Principal Investigator)
  • Hôpital Avicenne, Bobigny, France (Recruiting)
  • Hôpital Louis-Mourier, Colombes, France (Not yet recruiting)
    • David MOSZKOWICZ
    • David MOSZKOWICZ (Principal Investigator)
  • APHP Pitié Salpetrière, Paris, France (Not yet recruiting)
  • APHP Lariboisière, Paris, France (Recruiting)
    • Karine PAUTRAT
    • Karine PAUTRAT (Principal Investigator)
  • Hia Begin, Saint-Mandé, France (Not yet recruiting)
    • Catherine ARIVEUX
    • Catherine ARVIEUX (Principal Investigator)
  • Clinique de l'Estrée, Stains, France (Not yet recruiting)
    • Yamina LADJICI
    • Yamina LADJICI (Principal Investigator)
  • CHU de La Réunion, Saint-Denis, Reunion (Recruiting)
    • Radwan KASSIR
    • Radwan KASSIR (Principal Investigator)
  • CHU de La Réunion, Saint-Pierre, Reunion (Recruiting)
    • Johanna ZEMOUR
    • Johanna ZEMOUR (Principal Investigator)