NCT07887139

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

6 months

First QC Date

October 14, 2026

Last Update Submit

October 14, 2026

Conditions

CholelithiasisSymptomatic Gallstone Disease

Keywords

laparoscopic cholecystectomyHasson techniqueVeress needleallbladder extractiontrocar site

Outcome Measures

Primary Outcomes (2)

  • Access time

    Time from the first skin incision until the liver and gallbladder are visualised with the laparoscope

    Intraoperative

  • Gallbladder extraction time

    Time from complete detachment of the gallbladder from the liver bed until its removal through the skin

    Intraoperative

Secondary Outcomes (2)

  • Total operative time

    Intraoperative

  • Postoperative trocar-site pain

    6, 12 and 24 hours after surgery

Study Arms (2)

Hasson access with umbilical extraction

EXPERIMENTAL

Open (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision

Procedure: Hasson open access and umbilical gallbladder extractionProcedure: Veress needle access and epigastric 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

Procedure: Hasson open access and umbilical gallbladder extractionProcedure: Veress needle access and epigastric gallbladder extraction

Interventions

Hasson open access and umbilical gallbladder extractionPROCEDURE

Open (Hasson) umbilical access; gallbladder extracted in a retrieval bag through the umbilical incision

Hasson access with umbilical extractionVeress access with epigastric extraction
Veress needle access and epigastric gallbladder extractionPROCEDURE

Closed access with a Veress needle; gallbladder extracted in a retrieval bag through the epigastric port.

Hasson access with umbilical extractionVeress access with epigastric extraction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic cholelithiasis scheduled for elective laparoscopic cholecystectomy Age 18-70 years Body mass index ≤30 kg/m²

You may not qualify if:

  • Previous midline abdominal surgery Acute cholecystitis or a history of acute cholecystitis Conversion to open surgery, intraoperative gallbladder perforation or other intraoperative complication (excluded after randomisation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, İzmir Bozyaka Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Sedat Sedat, MD

    izmir şehir hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant General Surgeon

Study Record Dates

First Submitted

October 14, 2026

First Posted

October 21, 2026

Study Start

September 20, 2019

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

October 21, 2026

Record last verified: 2026-10

Locations

TU(1)