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Preoperative Counseling in Cholecystectomy

Primary Purpose

Vomiting, Nausea, Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Preoperative counseling
Sponsored by
Federal University of Mato Grosso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting focused on measuring Vomiting, Nausea, Postoperative pain, Feeling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult age (18-65 years-old),
  • both sexes and
  • candidates for an elective open cholecystectomy

Exclusion Criteria:

  • having diabetes mellitus,
  • chronic kidney failure,
  • chronic liver disease,
  • serum bilirubin > 2 mg/dL,
  • body mass index (BMI) > 35 kg/m2,
  • American Anesthesiologists Association (ASA) score > 3,
  • gastro-esophageal reflux,
  • gastroparesis or intestinal obstruction.

Patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (> 4 h) operative time were also excluded.

Sites / Locations

  • Hospital Universitario Julio Mullar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preoperative counseling

Control

Arm Description

The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.

The control group received no preoperative counseling either oral or written.

Outcomes

Primary Outcome Measures

Visual analogue scale
A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked.

Secondary Outcome Measures

Episodes of vomiting
Number of episodes of vomiting occurring until 24h after the operation

Full Information

First Posted
June 26, 2012
Last Updated
June 27, 2012
Sponsor
Federal University of Mato Grosso
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1. Study Identification

Unique Protocol Identification Number
NCT01629992
Brief Title
Preoperative Counseling in Cholecystectomy
Official Title
Preoperative Counseling in Cholecystectomy. A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Mato Grosso

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators examined whether a written plus verbal preoperative counseling for patients undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting and pain.
Detailed Description
This was a randomized, single-blinded, clinical study carried out at the Julio Muller University Hospital (Mato Grosso State, Brazil). This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving human subjects/patients were approved by the hospital Research Ethics Committee registered under number 697/CEP-HUJM/09. Written informed consent was obtained from all patients. Except for the preoperative counseling which was received only by the intervention group, all patients received the same protocol of perioperative care. The main endpoint of the study was the presence and the intensity of postoperative symptoms such as nausea, vomiting and pain. A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked. The questions were: "how severe was your pain during this period of 24h after the operation?", "how severe was the intensity of your nausea during this period of 24h after the operation? ", and "how great is your well-being at the present moment". For the first two questions the words at each end of the line were "no pain" and "severe pain", and "no nausea" and "severe nausea". For the well-being question the words were "no well-being" and "greatest well-being". The Vomiting was also recorded as a categorical variable (yes or no). The length of stay and postoperative complications were also collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea, Postoperative Pain, Feeling
Keywords
Vomiting, Nausea, Postoperative pain, Feeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperative counseling
Arm Type
Experimental
Arm Description
The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group received no preoperative counseling either oral or written.
Intervention Type
Other
Intervention Name(s)
Preoperative counseling
Other Intervention Name(s)
Preoperative information
Intervention Description
The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked.
Time Frame
24h after operation
Secondary Outcome Measure Information:
Title
Episodes of vomiting
Description
Number of episodes of vomiting occurring until 24h after the operation
Time Frame
During the first 24h after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult age (18-65 years-old), both sexes and candidates for an elective open cholecystectomy Exclusion Criteria: having diabetes mellitus, chronic kidney failure, chronic liver disease, serum bilirubin > 2 mg/dL, body mass index (BMI) > 35 kg/m2, American Anesthesiologists Association (ASA) score > 3, gastro-esophageal reflux, gastroparesis or intestinal obstruction. Patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (> 4 h) operative time were also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Aguilar-Nascimento, MD, PhD
Organizational Affiliation
Federal University of Mato Grosso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Julio Mullar
City
Cuiaba
State/Province
Mato Grosso
ZIP/Postal Code
78000-000
Country
Brazil

12. IPD Sharing Statement

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Preoperative Counseling in Cholecystectomy

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