Preoperative Counseling in Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier:
NCT01629992
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012

June 26, 2012
June 27, 2012
January 2009
November 2011   (final data collection date for primary outcome measure)
Visual analogue scale [ Time Frame: 24h after operation ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01629992 on ClinicalTrials.gov Archive Site
Episodes of vomiting [ Time Frame: During the first 24h after surgery ] [ Designated as safety issue: No ]
Number of episodes of vomiting occurring until 24h after the operation
Same as current
Not Provided
Not Provided
 
Preoperative Counseling in Cholecystectomy
Preoperative Counseling in Cholecystectomy. A Randomized Trial

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
  • Vomiting
  • Nausea
  • Postoperative Pain
  • Feeling
Other: Preoperative counseling
The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.
Other Name: Preoperative information
  • Experimental: Preoperative counseling
    The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.
    Intervention: Other: Preoperative counseling
  • No Intervention: Control
    The control group received no preoperative counseling either oral or written.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
December 2011
November 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01629992
preopcounseling, 697/CEP-HUJM/09
Yes
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul
Federal University of Mato Grosso do Sul
Not Provided
Principal Investigator: Jose Aguilar-Nascimento, MD, PhD Federal University of Mato Grosso do Sul
Federal University of Mato Grosso do Sul
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP