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Completed

NCT Number: NCT01629992

Preoperative Counseling in Cholecystectomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Universitario Julio Mullar

Cuiabá, Mato Grosso, 78000-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative counseling

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.

Other names: Preoperative information

Primary outcomes

  1. Visual analogue scale

    Time frame: 24h after operation

    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 outcomes

  1. Episodes of vomiting

    Time frame: During the first 24h after surgery

    Number of episodes of vomiting occurring until 24h after the operation

Sponsors and collaborators

Lead sponsor

Federal University of Mato Grosso

Other

Registry information

Official study title

Preoperative Counseling in Cholecystectomy. A Randomized Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2012
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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