VomitingPhase 2/3NCT01629992
Preoperative Counseling in Cholecystectomy
A Phase 2/3 study testing Preoperative counseling in people with Vomiting and Nausea, run by Federal University of Mato Grosso at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vomiting, Nausea, Postoperative Pain
- What is being tested?
- Preoperative counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult age (18-65 years-old),
- both sexes and
- candidates for an elective open cholecystectomy
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitario Julio Mullar
Cuiabá, Mato Grosso, 78000-000
About this study
Official title: 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.
Read the 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
- Being tested
- Preoperative counseling
- Keywords
- Vomiting, Nausea, Postoperative pain, Feeling
- Medical subject headings
- Vomiting, Nausea, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative counselingOther
Also called Preoperative information
The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative counseling | Experimental | The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group. Receives: Other: Preoperative counseling |
| Control | No intervention | The control group received no preoperative counseling either oral or written. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24h after operation
Secondary outcomes (1)
Episodes of vomiting
Number of episodes of vomiting occurring until 24h after the operation
Measured: During the first 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso
- Investigators
- Jose Aguilar-Nascimento, MD, PhD, Principal investigator, Federal University of Mato Grosso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629992
- Sponsor's protocol ID
- preopcounseling
- Other IDs
- 697/CEP-HUJM/09
- Status last verified
- Jun 2012
- First submitted
- 26 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Counseling in Cholecystectomy. A Randomized Trial
- ClinicalTrials.gov ID
- NCT01629992
- Acronym / sponsor ID
- preopcounseling
- Conditions
- Vomiting, Nausea, Postoperative Pain, Feeling
- Keywords
- Vomiting, Nausea, Postoperative pain, Feeling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative counseling | Experimental | Other: Preoperative counselingThe intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group. |
| Control | No intervention | –The control group received no preoperative counseling either oral or written. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult age (18-65 years-old),
- both sexes and
- candidates for an elective open cholecystectomy
Key exclusion criteria (9 listed)
- having diabetes mellitus,
- chronic kidney failure,
- chronic liver disease,
- serum bilirubin > 2 mg/dL,
- body mass index (BMI) > 35 kg/m2,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative counselingAlso: Preoperative informationThe 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 |
Primary outcome
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.
1 secondary outcome
Episodes of vomiting
Time frame: During the first 24h after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Aguilar-Nascimento, MD, PhD principal investigator
Federal University of Mato Grosso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Preoperative counseling in people with Vomiting and Nausea, run by Federal University of Mato Grosso at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 24h after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.