Preoperative Counseling in Cholecystectomy

Preoperative Counseling in Cholecystectomy. A Randomized Trial

Sponsors

Lead Sponsor: Federal University of Mato Grosso

Source Federal University of Mato Grosso
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.

Overall Status Completed
Start Date January 2009
Completion Date December 2011
Primary Completion Date November 2011
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual analogue scale 24h after operation
Secondary Outcome
Measure Time Frame
Episodes of vomiting During the first 24h after surgery
Enrollment 119
Condition
Intervention

Intervention Type: Other

Intervention Name: Preoperative counseling

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 Group Label: Preoperative counseling

Other Name: 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jose Aguilar-Nascimento, MD, PhD Principal Investigator Federal University of Mato Grosso
Location
Facility: Hospital Universitario Julio Mullar
Location Countries

Brazil

Verification Date

June 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Federal University of Mato Grosso

Investigator Full Name: Jose Eduardo de Aguilar-Nascimento

Investigator Title: Chairman Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Preoperative counseling

Type: Experimental

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.

Label: Control

Type: No Intervention

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Care Provider)

Source: ClinicalTrials.gov