Surgical Procedures, OperativeNCT04097054
The 3P Trial: Preoperative Planning and Preparation of Complex and Rare Procedures in GI Surgery
A study testing Augmented preoperative planning in people with Surgical Procedures, Operative, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedures, Operative
- What is being tested?
- Augmented preoperative planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age younger than 18 years,
- Emergency surgery or a time from outpatient visit to the operation <8 days.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel/Dep. of General and Visceral Surgery
Basel, Canton of Basel-City, 4031
About this study
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?
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.
Read the 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
- Being tested
- Augmented preoperative planning
- Keywords
- operative procedures, intraoperative monitoring, budgetary control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented preoperative planningProcedure or surgery
The study investigates the impact of augmented preoperative planning on OR time variance in complex and rare visceral surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Procedure: Augmented preoperative planning |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
delay/variability of operative time
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.
Measured: 1 year, measured after every operation
Secondary outcomes (4)
Costs
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.
Measured: 1 year, calculated after every case once patient is dismissed
Level of stress
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.
Measured: 1 year, measured during every operation
Number of intraoperative mistakes
Number of intraoperative mistakes will be recorded with a pedal button operated by the first assistant on the demand of the lead surgeon.
Measured: 1 year, measured during every operation and compiled after the operation is finished
Number and severity of intraoperative complications
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.
Measured: 1 year, measured during every operation and compiled after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start15 Nov 2022
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedures, OperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A single centre randomized open label trial.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco von Strauss und Torney, PD Dr. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097054
- Sponsor's protocol ID
- 3P2019
- Status last verified
- Mar 2024
- First submitted
- 17 Sep 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04097054
- Acronym / sponsor ID
- 3P2019
- Conditions
- Surgical Procedures, Operative
- Keywords
- operative procedures, intraoperative monitoring, budgetary control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single centre randomized open label trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Augmented preoperative planningPatients 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age younger than 18 years,
- Emergency surgery or a time from outpatient visit to the operation <8 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented preoperative planningThe study investigates the impact of augmented preoperative planning on OR time variance in complex and rare visceral surgical procedures. | Procedure or surgery | Intervention |
Primary outcome
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.
4 secondary outcomes
Costs
Time frame: 1 year, calculated after every case once patient is dismissed
Level of stress
Time frame: 1 year, measured during every operation
Number of intraoperative mistakes
Time frame: 1 year, measured during every operation and compiled after the operation is finished
Number and severity of intraoperative complications
Time frame: 1 year, measured during every operation and compiled after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco von Strauss und Torney, PD Dr. MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented preoperative planning in people with Surgical Procedures, Operative, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delay/variability of operative time (time frame: 1 year, measured after every operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.