Clinical trial NCT04097054: The 3P Trial: Preoperative Planning and Preparation of Complex and Rare Procedures in GI Surgery
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedures, Operative
Keywords: operative procedures
intraoperative monitoring
budgetary control
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A single centre randomized open label trial.
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: delay/variability of operative time
timeFrame: 1 year, measured after every operation
Secondary outcomes:
measure: Costs
timeFrame: 1 year, calculated after every case once patient is dismissed
measure: Level of stress
timeFrame: 1 year, measured during every operation
measure: Number of intraoperative mistakes
timeFrame: 1 year, measured during every operation and compiled after the operation is finished
measure: Number and severity of intraoperative complications
timeFrame: 1 year, measured during every operation and compiled after the operation
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel/Dep. of General and Visceral Surgery
state: Basel Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Marco von Strauss und Torney, PD Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: