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

University Hospital Basel

Status: Completed

Conditions: Surgical Procedures, Operative

Treatments: Procedure: Augmented preoperative planning

Study type: Interventional

Funder types: Other

Identifiers

NCT04097054

3P2019

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients in the interventional arm are operated after augmented planning of the procedure. The plan is prepared by the surgeon and made available to the study team a day prior to the procedure and on a screen in the OR during the procedure. The plan includes the current and next operative step, the used equipment and the approximate time used as well as the estimated time of when the procedure will end.

Treatment:

Procedure: Augmented preoperative planning

Control

No Intervention group

Description:

In the control cases no particular planning and distribution of operative plan is performed. The standard preparation only includes the distribution of information on the desired positioning of the patient, necessary special equipment and the overall estimated OR time.