Effects of Prone Position After Major Abdominal Surgery

NCT05630443 | Recruiting DMC

• 1 other identifier: 2021-06877-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.

Conditions

Surgery; Complications, Postoperative; Lung Infection

Keywords

complications postoperative; lungcomplications; abdominal surgery; prone position

Outcome Measures

Primary Outcomes (3)

• Oxygen saturation measurement postoperatively

  Measurement during sitting position

  an average of (POD) Postoperative day 2-7

• Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement

  Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis

  through study completion, an average of 1 year

• Number of participants with treatment-related adverse events of postoperative lung and abdominal complications

  Pneumonia, Lung embolism, Empyema of the lung, pankreatitis

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Number of participants with treatment-related diminished lung volumes

  through study completion, an average of 1 year

• Number of days of Hospital care

  through study completion, an average of 1 year

• Number of participants needing intervention

  through study completion, an average of 1 year

Study Arms (2)

ERAS

NO INTERVENTION

Ordinary ERAS treatment postoperatively without any prone position or voicetraining

+prone position

ACTIVE COMPARATOR

Ordinary ERAS treatment adding the prone position and voicetraining in short intervals

Procedure: prone position

Interventions

prone position PROCEDURE

Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining

+prone position

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- malignancy of the esophagus, gastric- or pancreas

You may not qualify if:

• not able to understand Swedish in writing or speaking
• \- preoperatively unable to perform a prone position

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Dept of Surgery

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cecilia Engstrom Mattisson, MD PhD

  Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Engstrom Mattisson, MD PhD

CONTACT

+46704970393; cecilia.engstrom.@surgery.gu.se

Cecilia Engstrom Mattisson, MD PhD

CONTACT

cecilia.engstrom.mattisson@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Associated Professor

Model Details: prospective randomized controlled study

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: November 29, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)