Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 1:39 AM
NCT ID: NCT01560494
Brief Summary: This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.
Detailed Description: The objective of this study was to develop and validate an ex-vivo comprehensive curriculum for a basic laparoscopic procedure. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex-vivo training on learning curves in the operating room (OR), nor the effect on non-technical proficiency has been investigated. This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured-curriculum (STAC) group or conventional residency training. The STAC curriculum consisted of: case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to: learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and non-technical skills.
Study: NCT01560494
Study Brief:
Protocol Section: NCT01560494