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Mucosal Injury Using Pharyngeal Packing

Primary Purpose

Sore Throat

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypopharyngeal packing
Without Hypopharyngeal packing
Sponsored by
Marienhospital Osnabrück
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Surgery of the sinuses
  • Patients over 18 years of age
  • Duration of surgery > 1h

Exclusion Criteria:

  • Refusal of the patient
  • Patients under 18 years of age
  • Chemotherapy with antiemetic medication
  • Combined surgery (for example tonsillectomie and sinus surgery)
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hypopharyngeal packing

    Without hypopharyngeal packing

    Arm Description

    Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.

    Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.

    Outcomes

    Primary Outcome Measures

    Incidence and severity of mucosal injury
    Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2016
    Last Updated
    August 29, 2022
    Sponsor
    Marienhospital Osnabrück
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02757300
    Brief Title
    Mucosal Injury Using Pharyngeal Packing
    Official Title
    Incidence of Mucosal Injury Using Pharyngeal Packing in Surgery of the Nasal Sinuses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study performer moved away
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Marienhospital Osnabrück

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
    Detailed Description
    Aim of the study Post-operative nausea and vomiting (PONV) is a complication of anaesthesia and responsible for malaise of surgical patients. Furthermore, PONV has been shown causing additive costs due to anti-emetic drugs and prolonged hospitalisation. The occurrence of PONV is multifactorial. Beside individual patients factors, opioid use and type of surgery seem to be responsible for occurrence of PONV. Especially, sinus surgery carries a high risk of PONV. Blood from the operation site entering the stomach has been discussed the potential cause for PONV in this specific patient population. Therefore, hypopharyngeal packing following orotracheal intubation is a common clinical practice to prevent blood passing through the esophagus and so to lower the incidence of PONV. Unfortunately, there are limited data data supporting the effectiveness of this procedure. In contrast, some references suggest that hypopharyngeal packing may be associated with postoperative mucosal injury and sore throat with high impact on patients´ well-being. To evaluate the usefulness and safety of hypopharyngeal packing the investigators perform prospective randomized study with the following objective: 1. Does pharyngeal packing during sinus surgery increase the incidence of mucosal injury?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sore Throat

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypopharyngeal packing
    Arm Type
    Experimental
    Arm Description
    Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
    Arm Title
    Without hypopharyngeal packing
    Arm Type
    Active Comparator
    Arm Description
    Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
    Intervention Type
    Device
    Intervention Name(s)
    Hypopharyngeal packing
    Intervention Description
    After introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed.
    Intervention Type
    Device
    Intervention Name(s)
    Without Hypopharyngeal packing
    Intervention Description
    After introduction and orotracheal intubation the patient will pass the operation without hypopharyngeal packing with a short tip coming out the mouth to imitate a packing.
    Primary Outcome Measure Information:
    Title
    Incidence and severity of mucosal injury
    Description
    Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management
    Time Frame
    Second postoperative day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Surgery of the sinuses Patients over 18 years of age Duration of surgery > 1h Exclusion Criteria: Refusal of the patient Patients under 18 years of age Chemotherapy with antiemetic medication Combined surgery (for example tonsillectomie and sinus surgery) Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin Beiderlinden, PD
    Organizational Affiliation
    Marienhospital Osnabrück
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Mucosal Injury Using Pharyngeal Packing

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