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NCT Number: NCT04097054

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

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.

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Key information

Conditions

Surgical Procedures, Operative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel/Dep. of General and Visceral Surgery

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Augmented preoperative planning

Procedure

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

Primary outcomes

  1. delay/variability of operative time

    Time frame: 1 year, measured after every operation

    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.

Secondary outcomes

  1. Costs

    Time frame: 1 year, calculated after every case once patient is dismissed

    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.

  2. Level of stress

    Time frame: 1 year, measured during every operation

    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.

  3. Number of intraoperative mistakes

    Time frame: 1 year, measured during every operation and compiled after the operation is finished

    Number of intraoperative mistakes will be recorded with a pedal button operated by the first assistant on the demand of the lead surgeon.

  4. Number and severity of intraoperative complications

    Time frame: 1 year, measured during every operation and compiled after the operation

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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?

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 20, 2019
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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