Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097054
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Surgical Procedures, Operative Procedure: Augmented preoperative planning Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A single centre randomized open label trial.
Masking: None (Open Label)
Primary Purpose: Treatment
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?
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 1, 2021

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

No Intervention: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097054


Contacts
Layout table for location contacts
Contact: Marco von Strauss und Torney, PD Dr. MD +41 61 777 73 21 marco.vonstrauss@clarunis.ch
Contact: Fabian Haak +41 61 777 73 41 fabian.haak@clarunis.ch

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Layout table for investigator information
Principal Investigator: Marco von Strauss und Torney, PD Dr. MD University Hospital, Basel, Switzerland

Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04097054     History of Changes
Other Study ID Numbers: 3P2019
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
operative procedures
intraoperative monitoring
budgetary control