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

NCT04097054 | Completed

• 1 other identifier: 3P2019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedures, Operative

Keywords

operative procedures; intraoperative monitoring; budgetary control

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year, measured after every operation

Secondary Outcomes (4)

• Costs

  1 year, calculated after every case once patient is dismissed

• Level of stress

  1 year, measured during every operation

• Number of intraoperative mistakes

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

• Number and severity of intraoperative complications

  1 year, measured during every operation and compiled after the operation

Study Arms (2)

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.

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.

Interventions

Augmented preoperative planning PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age younger than 18 years,
• Emergency surgery or a time from outpatient visit to the operation \<8 days.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel/Dep. of General and Visceral Surgery

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Marco von Strauss und Torney, PD Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centre randomized open label trial.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: November 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)