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

Surgical Procedures, Operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097054
• Other study ID #: 3P2019
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 29, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 and older,
• indication for a complex and rarely performed visceral surgical procedure (e.g. esophagectomy, Whipple operation, Gastrectomy, complex hepatobiliary surgery, multivisceral resections, rectal cancer surgery, revisional bariatric surgery),
• patient's written informed consent
• consent of the involved operating team

Exclusion Criteria:

• age younger than 18 years,
• Emergency surgery or a time from outpatient visit to the operation <8 days.

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

Procedure:
• Augmented preoperative planning
The study investigates the impact of augmented preoperative planning on OR time variance in complex and rare visceral surgical procedures.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel/Dep. of General and Visceral Surgery	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delay/variability of operative time	The primary outcome is the (delay/variability) of operative time as defined as time from skin incision to skin closure that will be recorded with the hospital OR planning program (Ismed Protect Data) and compared to preoperatively planned times.	1 year, measured after every operation
Secondary	Costs	Costs will be calculated as intraoperative delay compared to preoperative planning in minutes multiplied with the OR minute costs of the institution in addition to the average salaries per minute of the involved surgical staff. OR minute costs will be calculated by dividing the OR and anesthesia cost units through the overall operative time in the institution. The OR cost unit includes the personnel expenses for operating nurses and other staff (including cleaner and others) as well as maintenance costs (single use equipment, depreciation on buildings and running expenses like water and electricity etc. The cost unit anesthesia includes all expenses for personnel (doctors and nurses), depreciation for respirators and other devices as well as expandable materials.	1 year, calculated after every case once patient is dismissed
Secondary	Level of stress	Level of stress of each operating team member will be assessed directly postoperatively with a Visual Analogue Scale (VAS) report (operated on an ipad for data collection). The VAS Scale will consist of a 0 (no stress) to 7 (maximum stress) item scale.	1 year, measured during every operation
Secondary	Number of intraoperative mistakes	Number of intraoperative mistakes will be recorded with a pedal button operated by the first assistant on the demand of the lead surgeon.	1 year, measured during every operation and compiled after the operation is finished
Secondary	Number and severity of intraoperative complications	Number and severity of intraoperative complications will be assessed directly postoperatively by the lead surgeon and or first assistant, audio video records are available for review purposes. Postoperative complications will be recorded after discharge on the basis of discharge summary and proceeding notes of the patient.	1 year, measured during every operation and compiled after the operation