CholelithiasisNCT07887139
Hasson Versus Veress Access With Umbilical Versus Epigastric Gallbladder Extraction in Laparoscopic Cholecystectomy
A study testing Hasson open access and umbilical gallbladder extraction and Veress needle access and epigastric gallbladder extraction in people with Cholelithiasis and Symptomatic Gallstone Disease, run by Sedat Tan at 1 site in Turkey (Türkiye).
Trial summary
This single-centre randomised pilot study compared two strategies for primary abdominal access and gallbladder extraction in elective laparoscopic cholecystectomy: open (Hasson) umbilical access with extraction of the gallbladder through the umbilical incision, and closed (Veress needle) access with extraction through… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholelithiasis, Symptomatic Gallstone Disease
- What is being tested?
- Hasson open access and umbilical gallbladder extraction and Veress needle access and epigastric gallbladder extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2019to 20 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic cholelithiasis scheduled for elective laparoscopic cholecystectomy
- Age 18-70 years
- Body mass index ≤30 kg/m²
Who cannot join
- Previous midline abdominal surgery
- Acute cholecystitis or a history of acute cholecystitis
- Conversion to open surgery (excluded after randomisation)
- Intraoperative gallbladder perforation (excluded after randomisation)
- Other intraoperative complication (excluded after randomisation)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, İzmir Bozyaka Training and Research Hospital
Izmir
About this study
Official title: Effect of Gallbladder Extraction Through the Hasson Cannula on Operative Time and Pain in Laparoscopic Cholecystectomy: a Randomised Pilot Study
This single-centre randomised pilot study compared two strategies for primary abdominal access and gallbladder extraction in elective laparoscopic cholecystectomy: open (Hasson) umbilical access with extraction of the gallbladder through the umbilical incision, and closed (Veress needle) access with extraction through the epigastric port. Access time, gallbladder extraction time, total operative time and postoperative pain were compared. Enrolment was stopped in March 2020 when elective laparoscopic surgery was suspended because of the COVID-19 pandemic. This trial was registered retrospectively
Read the detailed description
Patients with symptomatic cholelithiasis scheduled for elective four-port laparoscopic cholecystectomy were randomised 1:1 with sealed opaque envelopes opened after induction of anaesthesia. In the Veress group, pneumoperitoneum was created with a Veress needle at the umbilicus and the gallbladder was extracted in a retrieval bag through the epigastric port. In the Hasson group, the umbilical port was placed by the open technique and the gallbladder was extracted in a retrieval bag through the umbilical incision after repositioning the camera. Fascia of both 10-mm ports was closed in both groups. Patients and the staff assessing postoperative pain were blinded to group allocation.
- Conditions
- Cholelithiasis, Symptomatic Gallstone Disease
- Being tested
- Hasson open access and umbilical gallbladder extraction, Veress needle access and epigastric gallbladder extraction
- Keywords
- laparoscopic cholecystectomy, Hasson technique, Veress needle, allbladder extraction, trocar site
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hasson open access and umbilical gallbladder extractionProcedure or surgery
Open (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision
Veress needle access and epigastric gallbladder extractionProcedure or surgery
Closed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port.
| Study group | Role | What they receive |
|---|---|---|
| Hasson access with umbilical extraction | Experimental | Open (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision Receives: Procedure: Hasson open access and umbilical gallbladder extraction |
| Veress access with epigastric extraction | Active comparator | Closed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port Receives: Procedure: Veress needle access and epigastric gallbladder extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access time
Time from the first skin incision until the liver and gallbladder are visualised with the laparoscope
Measured: Intraoperative
Gallbladder extraction time
Time from complete detachment of the gallbladder from the liver bed until its removal through the skin
Measured: Intraoperative
Secondary outcomes (2)
Total operative time
Time from skin incision to skin closure
Measured: Intraoperative
Postoperative trocar-site pain
Trocar-site pain assessed with a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain.
Measured: 6, 12 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start20 Sep 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sedat Tan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sedat Tan, Bozyaka Training and Research Hospital
- Investigators
- Sedat Sedat, MD, Principal investigator, izmir şehir hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887139
- Sponsor's protocol ID
- BOZYAKA-KAEK-2019-01
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gallbladder Extraction Through the Hasson Cannula on Operative Time and Pain in Laparoscopic Cholecystectomy: a Randomised Pilot Study
- ClinicalTrials.gov ID
- NCT07887139
- Acronym / sponsor ID
- BOZYAKA-KAEK-2019-01
- Conditions
- Cholelithiasis, Symptomatic Gallstone Disease
- Keywords
- laparoscopic cholecystectomy, Hasson technique, Veress needle, allbladder extraction, trocar site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sedat TanUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 21 Oct 2026 (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.
This single-centre randomised pilot study compared two strategies for primary abdominal access and gallbladder extraction in elective laparoscopic cholecystectomy: open (Hasson) umbilical access with extraction of the gallbladder through the umbilical incision, and closed (Veress needle) access with extraction through the epigastric port. Access time, gallbladder extraction time, total operative time and postoperative pain were compared. Enrolment was stopped in March 2020 when elective laparoscopic surgery was suspended because of the COVID-19 pandemic. This trial was registered retrospectively
Detailed description
Patients with symptomatic cholelithiasis scheduled for elective four-port laparoscopic cholecystectomy were randomised 1:1 with sealed opaque envelopes opened after induction of anaesthesia. In the Veress group, pneumoperitoneum was created with a Veress needle at the umbilicus and the gallbladder was extracted in a retrieval bag through the epigastric port. In the Hasson group, the umbilical port was placed by the open technique and the gallbladder was extracted in a retrieval bag through the umbilical incision after repositioning the camera. Fascia of both 10-mm ports was closed in both groups. Patients and the staff assessing postoperative pain were blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hasson access with umbilical extraction | Experimental | Procedure: Hasson open access and umbilical gallbladder extractionOpen (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision |
| Veress access with epigastric extraction | Active comparator | Procedure: Veress needle access and epigastric gallbladder extractionClosed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic cholelithiasis scheduled for elective laparoscopic cholecystectomy
- Age 18-70 years
- Body mass index ≤30 kg/m²
Key exclusion criteria (5 listed)
- Previous midline abdominal surgery
- Acute cholecystitis or a history of acute cholecystitis
- Conversion to open surgery (excluded after randomisation)
- Intraoperative gallbladder perforation (excluded after randomisation)
- Other intraoperative complication (excluded after randomisation)
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 |
|---|---|---|
| Hasson open access and umbilical gallbladder extractionOpen (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision | Procedure or surgery | Hasson access with umbilical extraction |
| Veress needle access and epigastric gallbladder extractionClosed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port. | Procedure or surgery | Veress access with epigastric extraction |
Primary outcome
Access time
Time frame: Intraoperative
Time from the first skin incision until the liver and gallbladder are visualised with the laparoscope
Gallbladder extraction time
Time frame: Intraoperative
Time from complete detachment of the gallbladder from the liver bed until its removal through the skin
2 secondary outcomes
Total operative time
Time frame: Intraoperative
Postoperative trocar-site pain
Time frame: 6, 12 and 24 hours 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 26 Oct 2026.
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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.
Sedat Sedat, MD principal investigator
izmir şehir hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hasson open access and umbilical gallbladder extraction and Veress needle access and epigastric gallbladder extraction in people with Cholelithiasis and Symptomatic Gallstone Disease, run by Sedat Tan 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 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 26 Oct 2026. 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?
Access time (time frame: Intraoperative). 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 26 Oct 2026.