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Related Concept Videos

Clinical Trials01:16

Clinical Trials

6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

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The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
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Updated: Jun 13, 2025

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SAME day amBulatory c (SAMBA): a multicenter, prospective, randomized clinical trial protocol.

Catherine Arvieux1,2, Fatah Tidadini3,4, Sandrine Barbois3

  • 1Department of Digestive and Emergency Surgery, Grenoble Alpes University Hospital, Grenoble, France. carvieux@chu-grenoble.fr.

Trials
|September 9, 2024
PubMed
Summary

Outpatient appendectomy for acute appendicitis is being tested against inpatient care in a large trial. This study aims to confirm its safety and feasibility, potentially improving patient recovery and hospital efficiency.

Keywords:
Ambulatory surgeryAppendectomyOutpatient surgeryPostoperative morbi-mortalityRandomized controlled trial

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Area of Science:

  • Surgical innovation
  • Clinical trials methodology
  • Gastrointestinal surgery

Background:

  • Previous meta-analysis suggests outpatient appendectomy is feasible and safe.
  • Lack of high-quality evidence necessitates a randomized controlled trial.
  • Outpatient appendectomy aims to reduce healthcare costs and improve patient experience.

Purpose of the Study:

  • To demonstrate non-inferiority of outpatient appendectomy versus inpatient appendectomy.
  • Primary endpoint: overall morbi-mortality at 30 days post-operation (D30).
  • To assess feasibility and reliability of outpatient appendectomy for uncomplicated acute appendicitis.

Main Methods:

  • Prospective, randomized, controlled, multicenter non-inferiority trial (SAMBA).
  • 1400 patients (15-74 years) with acute uncomplicated appendicitis undergoing laparoscopy.
  • Randomization to outpatient (day-surgery) or inpatient care; primary outcome D30 morbi-mortality.

Main Results:

  • Data collection ongoing; results not yet available.
  • Study duration: January 2023 - June 2025.
  • Secondary outcomes include re-hospitalization, re-interventions, and patient-reported outcomes.

Conclusions:

  • The SAMBA trial will provide crucial evidence on outpatient appendectomy.
  • Findings will inform clinical practice and hospital management strategies.
  • Successful implementation relies on adequate technical infrastructure.