General SurgeryNCT04270357
Surgical Practices in Algeria : the Cholecystectomy
An observational study of General Surgery and Cholecystectomy, run by University of Oran 1.
Trial summary
An anonymous national survey involving all practicing Algerian surgeons was conducted. At the end of the survey, all data were captured and processed using the SPSS v20 software; χ 2 tests were used to compare different groups of surgeons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Surgery, Cholecystectomy, Practice Guidelines as Topic
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Sep 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: any surgeon practicing in Algeria is subject to this survey. THE surgeons in Algeria are holders of a "DEMS or equivalent" diploma which authorizes them to perform surgery in Algeria.
Who may be able to join
- visceral an general surgeons practicing in Algeria.
Who cannot join
- surgeon under training.
- Algerian surgeon practicing abroad.
About this study
Official title: Surgical Practices During Cholecystectomy in Algeria: Results of a Survey
An anonymous national survey involving all practicing Algerian surgeons was conducted. At the end of the survey, all data were captured and processed using the SPSS v20 software; χ 2 tests were used to compare different groups of surgeons.
Read the detailed description
An anonymous national survey involving all practicing Algerian surgeons was conducted, this survey started the 1st November 2016 and ended the 1st September 2017.
Any digestive , general and visceral surgeon practicing in Algeria was eligible for this survey, surgeons in training "residents" and Algerian surgeons exercising overseas was systematically excluded.
The aim was to analyse some practice in accordance with the recommendations of the Society of American Gastrointestinal and Endoscopic Surgeons who published a guideline in 2010.
This elaborated form was an electronic one; it was performed using the open electronic platform "Google Form", the conception of the form was made by A.Tidjane "surgeon" and he was the first participant to this survey, considering his participation he was excluded from the seizure of the data. The analysis and interpretation of data was made by S.Benilha "bio-statistician", B.Tabeti "surgeon" and A.Tidjane.
The form consisted of two parts, the first concerning the surgeon's Wilaya of exercise, the rank of health structure of practice, his professional position , and the year of his graduation , the second part concerning his practices during the performing CH and the questions concerned the use of laparoscopy or open surgery to perform CH, the number of Trocars used, the technique to access the peritoneal cavity, the surgical technique, the use of intraoperative cholangiography "IOC", the technique of extraction of the gallbladder, systematic gallbladder macroscopic and histological examination, the systematic abdominal cavity drainage, systematic use of postoperative antibiotic prophylaxis, and the optimal duration of postoperative stay in the case of optimal patient with no preoperative incident or postoperative complication. At the end of the survey a question was asked to surgeons about the occurrence during their professional practice of an operative bile duct injury.
The language of instruction of surgeons in Algeria is French; the French was used to draft this form. This electronic form was distributed by email to all surgeons in the authors Mail lists, those first contacted surgeons had the mission not only to participate in this survey but also had the mission of distributing the electronic form to their surgeon colleagues. All incomplete responses were excluded.
Statistical analyses:
At the end of the survey, all data were captured and processed using the SPSS v20 software (IBM Inc., Chicago, IL, USA), a χ 2 tests were used to compare some surgical practices in different groups of surgeons, a (P < 0.05) was considered statistically significant.
- Being tested
- Cholecystectomy
- Keywords
- cholecystectomy, middle income country, gallbladder, laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Cholecystectomy is the surgical removal of the gallbladder. Cholecystectomy is a common treatment of symptomatic gallstones and other gallbladder conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of surgeons caracteristics on surgical practices
The variables measured were of two types:
A - linked to the characteristics of the surgeon participating in the survey:
- Exercice place.
- Type of exercise structure.
- Grade of surgeon.
- Date of graduation.
- Weekly volume of surgery.
- Use of laparoscopic surgery.
B- Related to the surgeon's own practices when he performs this surgery:
- Laparoscopic or open cholecystectomy.
- Respect for the different dissection times.
- Number of trocars.
- Number of clips placed for the cystic duct and the cystic artery.
- Rule of extraction of the gallbladder.
- Use of antibiotics postoperatively.
- Abdominal drainage.
- length of hospital stay after surgery.
To find a correlation between the variables of Group A and B, a test, a χ 2 tests were used to compare some surgical practices in different groups of surgeons, a (P < 0.05) was considered statistically significant.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Nov 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oran 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisse Tidjane, University of Oran 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270357
- Sponsor's protocol ID
- UOran1
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Practices During Cholecystectomy in Algeria: Results of a Survey
- ClinicalTrials.gov ID
- NCT04270357
- Acronym / sponsor ID
- UOran1
- Keywords
- cholecystectomy, middle income country, gallbladder, laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Oran 1University, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 17 Feb 2020 (actual)
- 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.
An anonymous national survey involving all practicing Algerian surgeons was conducted. At the end of the survey, all data were captured and processed using the SPSS v20 software; χ 2 tests were used to compare different groups of surgeons.
Detailed description
An anonymous national survey involving all practicing Algerian surgeons was conducted, this survey started the 1st November 2016 and ended the 1st September 2017.
Any digestive , general and visceral surgeon practicing in Algeria was eligible for this survey, surgeons in training "residents" and Algerian surgeons exercising overseas was systematically excluded.
The aim was to analyse some practice in accordance with the recommendations of the Society of American Gastrointestinal and Endoscopic Surgeons who published a guideline in 2010.
This elaborated form was an electronic one; it was performed using the open electronic platform "Google Form", the conception of the form was made by A.Tidjane "surgeon" and he was the first participant to this survey, considering his participation he was excluded from the seizure of the data. The analysis and interpretation of data was made by S.Benilha "bio-statistician", B.Tabeti "surgeon" and A.Tidjane.
The form consisted of two parts, the first concerning the surgeon's Wilaya of exercise, the rank of health structure of practice, his professional position , and the year of his graduation , the second part concerning his practices during the performing CH and the questions concerned the use of laparoscopy or open surgery to perform CH, the number of Trocars used, the technique to access the peritoneal cavity, the surgical technique, the use of intraoperative cholangiography "IOC", the technique of extraction of the gallbladder, systematic gallbladder macroscopic and histological examination, the systematic abdominal cavity drainage, systematic use of postoperative antibiotic prophylaxis, and the optimal duration of postoperative stay in the case of optimal patient with no preoperative incident or postoperative complication. At the end of the survey a question was asked to surgeons about the occurrence during their professional practice of an operative bile duct injury.
The language of instruction of surgeons in Algeria is French; the French was used to draft this form. This electronic form was distributed by email to all surgeons in the authors Mail lists, those first contacted surgeons had the mission not only to participate in this survey but also had the mission of distributing the electronic form to their surgeon colleagues. All incomplete responses were excluded.
Statistical analyses:
At the end of the survey, all data were captured and processed using the SPSS v20 software (IBM Inc., Chicago, IL, USA), a χ 2 tests were used to compare some surgical practices in different groups of surgeons, a (P < 0.05) was considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- any surgeon practicing in Algeria is subject to this survey. THE surgeons in Algeria are holders of a "DEMS or equivalent" diploma which authorizes them to perform surgery in Algeria.
Key inclusion criteria (1 listed)
- visceral an general surgeons practicing in Algeria.
Key exclusion criteria (2 listed)
- surgeon under training.
- Algerian surgeon practicing abroad.
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 |
|---|---|---|
| CholecystectomyCholecystectomy is the surgical removal of the gallbladder. Cholecystectomy is a common treatment of symptomatic gallstones and other gallbladder conditions | Procedure or surgery | – |
Primary outcome
Influence of surgeons caracteristics on surgical practices
Time frame: 11 months
The variables measured were of two types: A - linked to the characteristics of the surgeon participating in the survey: * Exercice place. * Type of exercise structure. * Grade of surgeon. * Date of graduation. * Weekly volume of surgery. * Use of laparoscopic surgery. B- Related to the surgeon's own practices when he performs this surgery: * Laparoscopic or open cholecystectomy. * Respect for the different dissection times. * Number of trocars. * Number of clips placed for the cystic duct and the cystic artery. * Rule of extraction of the gallbladder. * Use of antibiotics postoperatively. * Abdominal drainage. * length of hospital stay after surgery. To find a correlation between the variables of Group A and B, a test, a χ 2 tests were used to compare some surgical practices in different groups of surgeons, a (P < 0.05) was considered statistically significant.
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 18 Feb 2020.
- Individual participant dataSharing planned: No
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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 General Surgery and Cholecystectomy, run by University of Oran 1.
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 1 inclusion and 2 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 18 Feb 2020. 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?
Influence of surgeons caracteristics on surgical practices (time frame: 11 months). 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 18 Feb 2020.