NCT04097054

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

The 3P Trial: Preoperative Planning and Preparation of Complex and Rare Procedures in GI Surgery: Can we Improve the Operative Workflow and Patient Outcomes?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Surgical Procedures, Operative

Interventions

Type	Name	Description
PROCEDURE	Augmented preoperative planning	The study investigates the impact of augmented preoperative planning on OR time variance in complex and rare visceral surgical procedures.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-12-31
• Completion: 2024-02-29
• First posted: 2019-09-20
• Last updated: 2024-03-12

Locations

1 site across 1 country: Switzerland