Laparoscopic CholecystectomyNCT02852408
Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy
An observational study of Laparoscopic Cholecystectomy and Postoperative Pain, run by Umraniye Education and Research Hospital.
Trial summary
Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. Although it has low morbidity, postoperative pain is challenging situation like every other operation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2016
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have scheduled for laparoscopic cholecystectomy
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II
- Presumptive diagnosis of benign gallbladder disease
Who cannot join
- The patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease
About this study
Official title: Unintentional Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy: A Prospective Controlled Blinded Trial
Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. Although it has low morbidity, postoperative pain is challenging situation like every other operation.
Read the detailed description
Postoperative pain after laparoscopic cholecystectomy has a three component: parietal, visceral and referring (shoulder) pain. Although intensities of them can be various, all of them affects the total pain together. Unintentional liver cauterization during laparoscopic cholecystectomy is unwanted, but sometimes unavoidable complication/process. However its effect on postoperative pain is not studied with detail in literature.
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain
- Being tested
- Laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study | liver cauterized during laparoscopic cholecystectomy. Receives: Procedure: Laparoscopic cholecystectomy | |
| Control | liver not-cauterized during laparoscopic cholecystectomy. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) abdominal pain scores
Measured: Postoperative 2nd hour
Visual analog scale (VAS) abdominal pain scores
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatih Basak, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852408
- Sponsor's protocol ID
- LAP-COL-CAUTER
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unintentional Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy: A Prospective Controlled Blinded Trial
- ClinicalTrials.gov ID
- NCT02852408
- Acronym / sponsor ID
- LAP-COL-CAUTER
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Aug 2016 (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.
Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. Although it has low morbidity, postoperative pain is challenging situation like every other operation.
Detailed description
Postoperative pain after laparoscopic cholecystectomy has a three component: parietal, visceral and referring (shoulder) pain. Although intensities of them can be various, all of them affects the total pain together. Unintentional liver cauterization during laparoscopic cholecystectomy is unwanted, but sometimes unavoidable complication/process. However its effect on postoperative pain is not studied with detail in literature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Procedure: Laparoscopic cholecystectomyliver cauterized during laparoscopic cholecystectomy. |
| Control | – | Procedure: Laparoscopic cholecystectomyliver not-cauterized during laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have scheduled for laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-II
- Presumptive diagnosis of benign gallbladder disease
Key exclusion criteria (1 listed)
- The patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease
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 |
|---|---|---|
| Laparoscopic cholecystectomy | Procedure or surgery | Control, Study |
Primary outcome
Visual analog scale (VAS) abdominal pain scores
Time frame: Postoperative 2nd hour
Visual analog scale (VAS) abdominal pain scores
Time frame: Postoperative 24th hour
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 2 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Postoperative Pain, run by Umraniye Education and Research Hospital.
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 2 inclusion and 1 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 analog scale (VAS) abdominal pain scores (time frame: Postoperative 2nd hour). The study lists 2 primary outcomes in all. 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 2 Aug 2016.