Preoperative Counseling in Cholecystectomy

NCT ID: NCT01629992

Last Updated: 2012-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Vomiting; Nausea; Postoperative Pain; Feeling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Preoperative counseling

Intervention Type: OTHER

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 Type: OTHER

Other Intervention Names

Preoperative information

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Mato Grosso

OTHER

Sponsor Role: lead

Responsible Party

Jose Eduardo de Aguilar-Nascimento

Chairman Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Aguilar-Nascimento, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Mato Grosso

Locations

Hospital Universitario Julio Mullar

Cuiabá, Mato Grosso, Brazil

Countries

Brazil

Other Identifiers

697/CEP-HUJM/09

Identifier Type: OTHER

Identifier Source: secondary_id

preopcounseling

Identifier Type: -

Identifier Source: org_study_id