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
  Purpose

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.


Condition Intervention Phase
Vomiting
Nausea
Postoperative Pain
Feeling
Other: Preoperative counseling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Preoperative Counseling in Cholecystectomy. A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Federal University of Mato Grosso do Sul:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 119
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Control
The control group received no preoperative counseling either oral or written.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629992

Locations
Brazil
Hospital Universitario Julio Mullar
Cuiaba, Mato Grosso, Brazil, 78000-000
Sponsors and Collaborators
Federal University of Mato Grosso do Sul
Investigators
Principal Investigator: Jose Aguilar-Nascimento, MD, PhD Federal University of Mato Grosso do Sul
  More Information

No publications provided

Responsible Party: Jose Eduardo de Aguilar-Nascimento, Chairman Professor, Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier: NCT01629992     History of Changes
Other Study ID Numbers: preopcounseling, 697/CEP-HUJM/09
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Mato Grosso do Sul:
Vomiting
Nausea
Postoperative pain
Feeling

Additional relevant MeSH terms:
Pain, Postoperative
Vomiting
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014