The 3P Trial: Preoperative Planning & Preparation of Complex & Rare

Status Completed

Clinical Trial Summary

The aim of the present study is to develop, implement a planning tool for rare and complex visceral surgical procedures. With the successful implementation of the planning tool the study will contribute to the improvement of intraoperative processes and their outcome in low volume surgery and offer an alternative to continued centralization of surgical care especially in case of geographical or disease specific premises.

Clinical Trial Description

The quality of the intraoperative process is still a blind spot, when it comes to clinical surgical research in the operating room. In contrast to pre and postop process optimization with tools like the World Health Organization (WHO) checklist or the Enhanced Recovery after Surgery (ERAS) protocol intraoperative processes tend to be poorly defined especially in rare and complex visceral surgery (e.g. esophageal, pancreatic rectal resection, sarcoma surgery, revisional bariatric surgery). This leads to delay, increased stress of the operating team and increased intraoperative mistakes and eventually increased complication rates. From previous investigations we know that step by step planning and briefing of the entire OR Team can reduce operative interruptions. With the development of a dedicated planning tool which allows to create and distribute step by step protocols for rare and complex visceral surgical procedures to the entire OR Team we hope to decrease delays and reduce OR time variance. Objective: Development and implementation of a planning tool for rare and complex visceral surgical procedures. Outcomes: Primary outcome: (delay/variability) operative times as defined as time from skin incision to skin closure Secondary outcomes: - Costs - Influence of preoperative augmented planning on degree of and quality of teaching - Level of stress of each operating team member - Number of intraoperative mistakes - Number and severity of intraoperative and postoperative complications ;

Study Design

Related Conditions & MeSH terms

Surgical Procedures, Operative

Clinical Trial Details

NCT number	NCT04097054
Study type	Interventional
Source	University Hospital, Basel, Switzerland
Contact
Status	Completed
Phase	N/A
Start date	November 15, 2022
Completion date	February 29, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The 3P Trial: Preoperative Planning and Preparation of Complex and Rare Procedures in GI Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms