NCT03014817

Brief Summary

The present study aims at analyzing whether ultrasonic tissue coagulation dissection technique offers a smoother peri- and postoperative course and reduces the risk for conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared to electrocautery in case of acute cholecystitis The study is performed as a double-blinded study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included in the study are randomized to surgery with either the traditional electrocautery based technique or ultrasonic scalpel based dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

3.5 years

First QC Date

January 5, 2017

Last Update Submit

April 24, 2024

Conditions

Cholecystitis, Acute

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Postoperative complications registered according to Clavien-Dindo

    30 days

Secondary Outcomes (10)

  • Operative time

    3 hours

  • Level of technical complexity

    3 hours

  • Technical performance

    3 hours

  • Postoperative stay

    14 days

  • Sick leave

    30 days

  • +5 more secondary outcomes

Study Arms (2)

Ultrasonically activated scalpel

EXPERIMENTAL

Dissection with ultrasonically activated scalpel. Direction of dissection undecided but by experience most naturally fundus first.

Procedure: Ultrasonically activated scalpel

Electrocautery

ACTIVE COMPARATOR

Dissection with electrocautery. Direction of dissection undecided but by experience most naturally cystic duct first.

Procedure: Electrocautery

Interventions

Ultrasonically activated scalpelPROCEDURE

Dissection with ultrasonically activated scalpel

Ultrasonically activated scalpel
ElectrocauteryPROCEDURE

Dissection with electrocautery

Electrocautery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency laparoscopic cholecystectomy performed for cholecystitis
  • American Society of Anesthesiologists (ASA) score I-III

You may not qualify if:

  • Patients unable to express themselves in Swedish
  • Pregnancy
  • Previous open surgery in the upper abdomen
  • American Society of Anesthesiologists (ASA) score \>III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Center for Digestive Diseases

Stockholm, 14186, Sweden

Location

Related Publications (1)

  • Blohm M, Sandblom G, Enochsson L, Cengiz Y, Bayadsi H, Hennings J, Diaz Pannes A, Stenberg E, Bewo K, Osterberg J. Ultrasonic dissection versus electrocautery dissection in laparoscopic cholecystectomy for acute cholecystitis: a randomized controlled trial (SONOCHOL-trial). World J Emerg Surg. 2024 Nov 13;19(1):34. doi: 10.1186/s13017-024-00565-4.

    PMID: 39538278DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Gabriel Sandblom, Assoc Prof

    Karolinska Institutet

    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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 9, 2017

Study Start

October 1, 2019

Primary Completion

March 22, 2023

Study Completion

March 22, 2023

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)