GallstoneNCT06953713
TSH Risk by Extraction Site in Lap Cholecystectomy
A study testing gallbladder extraction umbilical and extracting gallbladder via epigastric port in people with Gallstone, run by Fatih Basak at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of this study is to determine whether removing the gallbladder through different incision sites (ports) during laparoscopic surgery affects the risk of developing an incisional hernia. All patients undergo the same number of incisions, and the surgical technique remains standardized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone
- What is being tested?
- gallbladder extraction umbilical and extracting gallbladder via epigastric port
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 4 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Gallbladder stones
- No known systemic comorbidities (e.g., cardiovascular, pulmonary, metabolic, or immunologic conditions)
Who cannot join
- Age < 18 years,
- Open cholecystectomy or conversion from laparoscopy to open surgery,
- Acute cholecystitis
- Prior intervention involving the common bile duct,
- Presence of clinical or radiologic diastasis recti,
- Presence of clinical or radiologic umbilical hernia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Research and Training Hospital
Istanbul, Umraniye, 34760
About this study
Official title: Umbilical Trochar Site Is The Usual Suspect For Trocar Hernia After Laparoscopic Cholecystectomy: A Prospective Study
The main purpose of this study is to determine whether removing the gallbladder through different incision sites (ports) during laparoscopic surgery affects the risk of developing an incisional hernia. All patients undergo the same number of incisions, and the surgical technique remains standardized.
The study also aims to identify other factors that may contribute to the risk of hernia formation following gallbladder surgery.
Read the detailed description
Patients were blinded to group assignment. Randomization was conducted on the day of surgery by a surgical nurse using the Alea Randomisation mobile application (Alea Clinical Services, Abcoude, Netherlands). Group allocation ("U" for umbilical or "E" for epigastric) was placed in a sealed envelope and delivered to the operating room. The envelope was opened by the attending surgeon immediately prior to gallbladder retrieval.
Due to the nature of the intervention, the operating surgeon could not be blinded; however, surgeons remained unaware of group allocation until the moment of specimen retrieval. All procedures were performed by one of three experienced surgeons.
A conventional four-port laparoscopic cholecystectomy was performed in all cases, using a 10 mm umbilical camera trocar, a 10 mm epigastric trocar, and two 5 mm subcostal trocars. Gallbladder retrieval was performed using a laparoscopic specimen bag through one of the following approaches:
Group U: Gallbladder retrieved through the umbilical trocar
Group E: Gallbladder retrieved through the epigastric trocar
After retrieval and hemostasis, all trocars were removed under direct laparoscopic vision. The umbilical fascia was closed using two interrupted polyglactin 910 sutures (Vicryl, Ethicon Inc., Edinburgh, Scotland), while the epigastric trocar fascia was left unsutured. Fascia closure practices were standardized and unrelated to group allocation. Total operation time and gallbladder retrieval time were recorded.
All patients received paracetamol (Parol, Atabay İlaç, Istanbul, Türkiye) three times daily and tramadol (Contramal, Abdi İbrahim İlaç, Istanbul, Türkiye) twice daily for postoperative pain control. Pain was assessed using the Visual Analogue Scale (VAS) at 6 and 24 hours postoperatively, with the assistance of a ward nurse.
Patients without complications were discharged on postoperative day 1. Those with complications were discharged following resolution of their condition. All patients were followed for one year postoperatively. Patients presenting with hernia-related symptoms (e.g., bulge or pain) underwent ultrasonography (USG) at symptom onset, while asymptomatic patients received routine USG at the six-month and one-year follow-ups. Radiologists performing USGs were not affiliated with the study and were not standardized.
Incisional hernia was defined as a pathological fascial defect at a postoperative trocar site with protrusion of intraabdominal contents. Both clinically and radiologically diagnosed hernias were considered incisional hernias.
- Conditions
- Gallstone
- Being tested
- gallbladder extraction umbilical, extracting gallbladder via epigastric port
- Keywords
- Trocar site hernia, laparoscopic cholecystectomy, incisional hernia, port site hernia
- Medical subject headings
- Gallstones, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallbladder extraction umbilicalProcedure or surgery
extracting gallbladder via umbilical port site
extracting gallbladder via epigastric portProcedure or surgery
extracting gallbladder via epigastric port
| Study group | Role | What they receive |
|---|---|---|
| Umbilical group (Group U) | Experimental | Gallbladder retrieved via the umbilical trocar following standard 4-port laparoscopic cholecystectomy Receives: Procedure: gallbladder extraction umbilical |
| Epigastric group (Group E) | Active comparator | Gallbladder retrieved via the epigastric trocar following standard 4-port laparoscopic cholecystectomy Receives: Procedure: extracting gallbladder via epigastric port |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Trocar Site Hernia Following Laparoscopic Cholecystectomy
The primary outcome is to determine whether the site of gallbladder retrieval influences the incidence of postoperative incisional hernia following laparoscopic cholecystectomy.
Measured: From operation to end of follow-up period at 1 year
Secondary outcomes (2)
Postoperative Pain Assessed by Visual Analog Scale (VAS) at 6 and 24 Hours
This outcome evaluates the relationship between the gallbladder extraction site and postoperative pain, measured using the Visual Analog Scale (VAS) at 6 and 24 hours after surgery. The VAS is a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Measured: From end of operation to postoperative 24 hours
Incidence of Trocar Site Hernia in Relation to Patient- and Surgery-Related Risk Factors
This outcome measures the incidence of trocar site hernia during a one-year follow-up and evaluates its statistical correlation with various clinical and surgical risk factors. These include age (years), sex (male/female), BMI (kg/m²), diabetes status (yes/no), extraction site location (umbilical or epigastric), fascial closure status (closed/open), and intraoperative widening of the extraction site (yes/no). The hernia diagnosis will be based on clinical evaluation and ultrasonographic confirmation.
Data will be analyzed using correlation or regression methods to assess the strength of association between these variables and hernia development.
Measured: From operation to end of follow-up period at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Apr 2022
- Primary completion15 Jun 2024
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GallstoneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A standard four-trocar LC was performed using a 10 mm umbilical camera trocar, a 10 mm epigastric trocar, and two 5 mm subcostal trocars. The gallbladder was retrieved using a laparoscopic specimen bag through either: Group U: Gallbladder retrieved via the umbilical trocar, Group E: Gallbladder retrieved via the epigastric trocar.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Basak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fatih Basak, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953713
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/27
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data, consent forms, CSR, SAP
Publications
Sood S, Imsirovic A, Sains P, Singh KK, Sajid MS. Epigastric port retrieval of the gallbladder following laparoscopic cholecystectomy is associated with the reduced risk of port site infection and port site incisional hernia: An updated meta-analysis of randomized controlled trials. Ann Med Surg (Lond). 2020 May 25;55:244-251. doi: 10.1016/j.amsu.2020.05.017. eCollection 2020 Jul.
PubMed 32528673
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Trochar Site Is The Usual Suspect For Trocar Hernia After Laparoscopic Cholecystectomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT06953713
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/27
- Conditions
- Gallstone
- Keywords
- Trocar site hernia, laparoscopic cholecystectomy, incisional hernia, port site hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fatih BasakOther government
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 1 May 2025 (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.
The main purpose of this study is to determine whether removing the gallbladder through different incision sites (ports) during laparoscopic surgery affects the risk of developing an incisional hernia. All patients undergo the same number of incisions, and the surgical technique remains standardized.
The study also aims to identify other factors that may contribute to the risk of hernia formation following gallbladder surgery.
Detailed description
Patients were blinded to group assignment. Randomization was conducted on the day of surgery by a surgical nurse using the Alea Randomisation mobile application (Alea Clinical Services, Abcoude, Netherlands). Group allocation ("U" for umbilical or "E" for epigastric) was placed in a sealed envelope and delivered to the operating room. The envelope was opened by the attending surgeon immediately prior to gallbladder retrieval.
Due to the nature of the intervention, the operating surgeon could not be blinded; however, surgeons remained unaware of group allocation until the moment of specimen retrieval. All procedures were performed by one of three experienced surgeons.
A conventional four-port laparoscopic cholecystectomy was performed in all cases, using a 10 mm umbilical camera trocar, a 10 mm epigastric trocar, and two 5 mm subcostal trocars. Gallbladder retrieval was performed using a laparoscopic specimen bag through one of the following approaches:
Group U: Gallbladder retrieved through the umbilical trocar
Group E: Gallbladder retrieved through the epigastric trocar
After retrieval and hemostasis, all trocars were removed under direct laparoscopic vision. The umbilical fascia was closed using two interrupted polyglactin 910 sutures (Vicryl, Ethicon Inc., Edinburgh, Scotland), while the epigastric trocar fascia was left unsutured. Fascia closure practices were standardized and unrelated to group allocation. Total operation time and gallbladder retrieval time were recorded.
All patients received paracetamol (Parol, Atabay İlaç, Istanbul, Türkiye) three times daily and tramadol (Contramal, Abdi İbrahim İlaç, Istanbul, Türkiye) twice daily for postoperative pain control. Pain was assessed using the Visual Analogue Scale (VAS) at 6 and 24 hours postoperatively, with the assistance of a ward nurse.
Patients without complications were discharged on postoperative day 1. Those with complications were discharged following resolution of their condition. All patients were followed for one year postoperatively. Patients presenting with hernia-related symptoms (e.g., bulge or pain) underwent ultrasonography (USG) at symptom onset, while asymptomatic patients received routine USG at the six-month and one-year follow-ups. Radiologists performing USGs were not affiliated with the study and were not standardized.
Incisional hernia was defined as a pathological fascial defect at a postoperative trocar site with protrusion of intraabdominal contents. Both clinically and radiologically diagnosed hernias were considered incisional hernias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A standard four-trocar LC was performed using a 10 mm umbilical camera trocar, a 10 mm epigastric trocar, and two 5 mm subcostal trocars. The gallbladder was retrieved using a laparoscopic specimen bag through either: Group U: Gallbladder retrieved via the umbilical trocar, Group E: Gallbladder retrieved via the epigastric trocar.
| Arm | Type | Receives |
|---|---|---|
| Umbilical group (Group U) | Experimental | Procedure: gallbladder extraction umbilicalGallbladder retrieved via the umbilical trocar following standard 4-port laparoscopic cholecystectomy |
| Epigastric group (Group E) | Active comparator | Procedure: extracting gallbladder via epigastric portGallbladder retrieved via the epigastric trocar following standard 4-port laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years,
- Gallbladder stones
- No known systemic comorbidities (e.g., cardiovascular, pulmonary, metabolic, or immunologic conditions)
Key exclusion criteria (6 listed)
- Age < 18 years,
- Open cholecystectomy or conversion from laparoscopy to open surgery,
- Acute cholecystitis
- Prior intervention involving the common bile duct,
- Presence of clinical or radiologic diastasis recti,
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 |
|---|---|---|
| gallbladder extraction umbilicalextracting gallbladder via umbilical port site | Procedure or surgery | Umbilical group (Group U) |
| extracting gallbladder via epigastric portextracting gallbladder via epigastric port | Procedure or surgery | Epigastric group (Group E) |
Primary outcome
Incidence of Trocar Site Hernia Following Laparoscopic Cholecystectomy
Time frame: From operation to end of follow-up period at 1 year
The primary outcome is to determine whether the site of gallbladder retrieval influences the incidence of postoperative incisional hernia following laparoscopic cholecystectomy.
2 secondary outcomes
Postoperative Pain Assessed by Visual Analog Scale (VAS) at 6 and 24 Hours
Time frame: From end of operation to postoperative 24 hours
Incidence of Trocar Site Hernia in Relation to Patient- and Surgery-Related Risk Factors
Time frame: From operation to end of follow-up period at 1 year
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 1 May 2025.
- Background: PubMed 32528673Sood S, Imsirovic A, Sains P, Singh KK, Sajid MS. Epigastric port retrieval of the gallbladder following laparoscopic cholecystectomy is associated with the reduced risk of port site infection and port site incisional hernia: An updated meta-analysis of randomized controlled trials. Ann Med Surg (Lond). 2020 May 25;55:244-251. doi: 10.1016/j.amsu.2020.05.017. eCollection 2020 Jul.
- Individual participant dataSharing planned: Yes. Raw data, consent forms, CSR, SAP
Related trials for Gallstone
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RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gallbladder extraction umbilical and extracting gallbladder via epigastric port in people with Gallstone, run by Fatih Basak 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 3 inclusion and 6 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 1 May 2025. 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?
Incidence of Trocar Site Hernia Following Laparoscopic Cholecystectomy (time frame: From operation to end of follow-up period at 1 year). 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 NCT06953713, which also lists 1 linked publication.
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 1 May 2025.