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.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Postoperative Pain; Feeling
• Intervention / Treatment: Other: Preoperative counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Mato Grosso
    • Cuiaba, Mato Grosso, Brazil, 78000-000
      • Hospital Universitario Julio Mullar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Preoperative information
No Intervention: Control; The control group received no preoperative counseling either oral or written.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24h after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of vomiting	Number of episodes of vomiting occurring until 24h after the operation	During the first 24h after surgery

Collaborators and Investigators

• Sponsor: Federal University of Mato Grosso
• Investigators: Principal Investigator: Jose Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Postoperative pain; Feeling
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting
• Other Study ID Numbers: preopcounseling; 697/CEP-HUJM/09 (Other Identifier: HUJM Research Ethics Committee)