NCT06812182

Brief Summary

Objectives: Evaluate the effect of a nurse guided enhanced recovery pathway on postoperative respiratory tract infection in Hepatico-Pancreatic -Biliary surgery \[ pre-operative patient counselling for postoperative respiratory physiotherapy techniques and emphasis on perfect training\]. Design: Quasi-experimental study. Setting: The study was conducted in surgical department, operation unit and intensive care unit at AlRajhy liver hospital. Subjects: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group (30patient each). The control started the first then the study group. Tools: Three tools were used. Tool I: Patient assessment sheet. Tool II: Clinical pathway protocol. Tool III: Clinical outcome evaluation. The control group received tools I and III only while study group received the three tools including clinical pathway protocol \[tool II\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

February 1, 2025

Last Update Submit

February 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative pulmonary infection

    Presence of 3 of the following: tachypnea more than 30/min, expectoration, and hypoxia, respiratory distress

    6 hours postoperatively, day 1, Day 2, and day 3

Study Arms (2)

control

NO INTERVENTION

All the patients admitted to surgical department during the period from early Augusts 2023until the end November 2023 matching the inclusion criteria for this study were included in the control group. The control group contained 30 patients with the same designed criteria. The control group received routine daily care of the hospital. For the control group, the two designed study tools used to assess the patients daily and detect the clinical outcomes of the patients \[tool I and tool III\] only.

study group

EXPERIMENTAL

educational training sessions were provided to care providers including the purpose and the process of implementing the pathway for one week. Following the training thee researchers started to make recruitment and screen for the study group, the researchers received consent from administration to start the data for the study group. The oral and written consent from the patient was also done, to allow the researchers to observe, make daily assessment and manage the patients according to the designed clinical pathway. After completion of the recruitment and screening, all patients admitted to the surgical unit during the five months period from first December 2023 until the end of April 2024 were assessed and managed as study group. The study group also estimated 30 patients that met the inclusion criteria. For the study group, the three designed study tools used to assess the patients daily and detect the clinical outcomes of the patients \[tool I, tool II and tool III\]

Behavioral: nurse guided clinical pathway

Interventions

Educational training sessions were provided to care providers for one week. Pre-operative; counseling and education of patient for chest physiotherapy, using spirometry, bowel preparation, early mobilization and how to predict common complications with learning to cooperate with nurses. Emphasis on patients to co-operate postoperatively was strongly stressed in spite of the pain and weakness. Intra-operative: Optimal fluid management, short acting anesthetics, regional analgesia, opioids-sparing anesthesia, small incisions, avoiding drains, maintaining normothermia, venous thrombo-embolism \[VTE\] prophylaxis and antibiotic prophylaxis were routinely done. Post-operative: Early oral nutrition, optimal fluid management, multimodal non-opioid analgesia, postoperative nausea and vomiting PONV prophylaxis, stimulation of gut motility, early removal of catheters and drains, early mobilization, chest physiotherapy and using spirometry effectively.

study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to communicate
  • Patients without vital failure \[renal, hepatic, cardiac\].

You may not qualify if:

  • Past history of other organ cancer
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine - Assiut university

Asyut, Egypt

Location

Study Officials

  • Ayman AM Abouglala

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 6, 2025

Study Start

May 1, 2023

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations