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

NCT ID: NCT04097054

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-02-29

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

Conditions

Surgical Procedures, Operative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Augmented preoperative planning

Intervention Type: PROCEDURE

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

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Augmented preoperative planning

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco von Strauss und Torney, PD Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel/Dep. of General and Visceral Surgery

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

3P2019

Identifier Type: -

Identifier Source: org_study_id