An interventional study of Hasson open access and umbilical gallbladder extraction and Veress needle access and epigastric gallbladder extraction in Cholelithiasis and Symptomatic Gallstone Disease, sponsored by Sedat Tan. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Sedat Tan · Not applicable, Interventional, and Treatment
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
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.
291 studies on the registry are indexed under Cholelithiasis; 49 are open to participants now.
This study's enrollment of 58 is below the median of 90 across 201 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →This is the only study on the registry with Sedat Tan as lead sponsor.
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The criteria were revised on the registry on Oct 26, 2026. See what changed
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Exclusion Criteria:
Open (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision
Procedure: Hasson open access and umbilical gallbladder extraction
Closed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port
Procedure: Veress needle access and epigastric gallbladder extraction
Open (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision
Closed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port.
Access time
Time from the first skin incision until the liver and gallbladder are visualised with the laparoscope
Time frame: Intraoperative
Gallbladder extraction time
Time from complete detachment of the gallbladder from the liver bed until its removal through the skin
Time frame: Intraoperative
Total operative time
Time from skin incision to skin closure
Time frame: 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.
Time frame: 6, 12 and 24 hours after surgery
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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