Wound InfectionNCT02788942
The Removing Port of the Laparoscopic Cholecystectomy Material
A study testing Removing from Epigastric port in people with Wound Infection, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators are investigating the effect of the removing of cholecystectomy material from different ports, to the port site infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- Removing from Epigastric port
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Jan 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has cholelithiasis
Who cannot join
- Subject has perforated gallbladder
- Subject has malignancy
- Subject has increasing wall thickness of the gallbladder
- Subject has malignancy in the preoperative ultrasonography in the gallbladder
- Subject has pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Etfal Training and Research Hospital
Istanbul, 34371
About this study
Official title: The Relationship Between the Removing Port of the Laparoscopic Cholecystectomy Material and the Port Site Infections
Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators are investigating the effect of the removing of cholecystectomy material from different ports, to the port site infections.
Read the detailed description
Laparoscopic cholecystectomy is gold standard for gallstones. But there is no consensus about which port place is optimal for the removing of the cholecystectomy material from the abdomen. There are different port site infections rates in the literature. The minimal tissue damage of laparoscopic cholecystectomy suggests a lower risk of wound infection, but there are series with an infection range of 8 %. The investigators are investigating is there any difference at the port site infection rates when the cholecystectomy material removed from different ports from the abdomen at the laparoscopic cholecystectomy.
- Conditions
- Wound Infection
- Being tested
- Removing from Epigastric port
- Keywords
- Port, Infection, cholecystectomy
- Medical subject headings
- Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removing from Epigastric portProcedure or surgery
The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured
| Study group | Role | What they receive |
|---|---|---|
| Umbilical | No intervention | The cholecystectomy material will be removed from umbilical port as usual. This will be control group. Port site infection rates will be measured. |
| Epigastric | Experimental | The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured. Receives: Procedure: Removing from Epigastric port |
What is being measured
The primary outcome is the main question the study is designed to answer.
Port site infections
The cholecystectomy material will be removed from umbilical port at the control group, from the epigastric port at the experimental group. The port site infection rates will be noted.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Cemal Kaya, Principal investigator, Sisli Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788942
- Sponsor's protocol ID
- Trochar
- Status last verified
- Feb 2019
- First submitted
- 24 May 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Once a three months time
Publications
Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Pares D. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial. Surg Endosc. 2017 Jan;31(1):249-254. doi: 10.1007/s00464-016-4965-z. Epub 2016 May 13.
PubMed 27177957Farooq U, Rashid T, Naheed A, Barkat N, Iqbal M, Sultana Q. COMPLICATIONS OF LAPAROSCOPIC CHOLECYSTECTOMY: AN EXPERIENCE OF 247 CASES. J Ayub Med Coll Abbottabad. 2015 Apr-Jun;27(2):407-10.
PubMed 26411129Comajuncosas J, Hermoso J, Gris P, Jimeno J, Orbeal R, Vallverdu H, Lopez Negre JL, Urgelles J, Estalella L, Pares D. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg. 2014 Jan;207(1):1-6. doi: 10.1016/j.amjsurg.2013.05.010. Epub 2013 Oct 7.
PubMed 24112669
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Removing Port of the Laparoscopic Cholecystectomy Material and the Port Site Infections
- ClinicalTrials.gov ID
- NCT02788942
- Acronym / sponsor ID
- Trochar
- Conditions
- Wound Infection
- Keywords
- Port, Infection, cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Jun 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 gold standard for gallstones. In this study the investigators are investigating the effect of the removing of cholecystectomy material from different ports, to the port site infections.
Detailed description
Laparoscopic cholecystectomy is gold standard for gallstones. But there is no consensus about which port place is optimal for the removing of the cholecystectomy material from the abdomen. There are different port site infections rates in the literature. The minimal tissue damage of laparoscopic cholecystectomy suggests a lower risk of wound infection, but there are series with an infection range of 8 %. The investigators are investigating is there any difference at the port site infection rates when the cholecystectomy material removed from different ports from the abdomen at the laparoscopic cholecystectomy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical | No intervention | –The cholecystectomy material will be removed from umbilical port as usual. This will be control group. Port site infection rates will be measured. |
| Epigastric | Experimental | Procedure: Removing from Epigastric portThe cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has cholelithiasis
Key exclusion criteria (5 listed)
- Subject has perforated gallbladder
- Subject has malignancy
- Subject has increasing wall thickness of the gallbladder
- Subject has malignancy in the preoperative ultrasonography in the gallbladder
- Subject has pregnancy
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 |
|---|---|---|
| Removing from Epigastric portThe cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured | Procedure or surgery | Epigastric |
Primary outcome
Port site infections
Time frame: 2 days
The cholecystectomy material will be removed from umbilical port at the control group, from the epigastric port at the experimental group. The port site infection rates will be noted.
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 19 Feb 2019.
- Results publication: PubMed 27177957Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Pares D. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial. Surg Endosc. 2017 Jan;31(1):249-254. doi: 10.1007/s00464-016-4965-z. Epub 2016 May 13.
- Results publication: PubMed 26411129Farooq U, Rashid T, Naheed A, Barkat N, Iqbal M, Sultana Q. COMPLICATIONS OF LAPAROSCOPIC CHOLECYSTECTOMY: AN EXPERIENCE OF 247 CASES. J Ayub Med Coll Abbottabad. 2015 Apr-Jun;27(2):407-10.
- Results publication: PubMed 24112669Comajuncosas J, Hermoso J, Gris P, Jimeno J, Orbeal R, Vallverdu H, Lopez Negre JL, Urgelles J, Estalella L, Pares D. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg. 2014 Jan;207(1):1-6. doi: 10.1016/j.amjsurg.2013.05.010. Epub 2013 Oct 7.
- Individual participant dataSharing planned: Yes. Once a three months time
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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.
Cemal Kaya principal investigator
Sisli Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removing from Epigastric port in people with Wound Infection, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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 19 Feb 2019. 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 Turkey (Türkiye). 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.
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?
Port site infections (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788942, which also lists 3 linked publications.
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 19 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.