NCT02156947

Brief Summary

In theory, increased vascularity of GB wall could be associated with intraoperative findings, such as, GB wall inflammation and accompanying adhesions. There are not enough reports in the literature describing the correlation between GB wall vascularity and operative findings according to adhesion scoring scale. In this prospective clinical study, we aimed to highlight the correlation between preoperative power Doppler sonography detected GB wall vascularity and intraoperative findings - postoperative outcomes of chronic and acute cholecystitis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

1.5 years

First QC Date

June 1, 2014

Last Update Submit

June 3, 2014

Conditions

Keywords

Power Doppler sonographycholecystitis, adhesion

Outcome Measures

Primary Outcomes (1)

  • Correlation between wall thickness-vascularity and adhesion grade

    Correlation between gallbladder wall thickness - vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and intraoperative adhesion grade (as measured by gallbladder adhesion scoring scale) of chronic and acute cholecystitis patients.

    Up to ten days

Secondary Outcomes (6)

  • Correlation between vascularity and gallbladder perforation

    Up to ten days

  • Correlation between vascularity and convertion

    Up to ten days

  • Correlation between vascularity and operation time

    Up to ten days

  • Correlation between vascularity and drain usage

    Up to ten days

  • Correlation between vascularity and specimen

    Up to twenty days

  • +1 more secondary outcomes

Study Arms (2)

Chronic cholecystitis

Laparoscopic cholecystectomy was performed. Gallbladder adhesion score and intraoperative findings of patients were assessed. Adhesion score, gallbladder perforation during the dissection, convertion to open cholecystectomy, operation time, drain usage and intraoperative complications were recorded.

Procedure: Laparoscopic cholecystectomy

Acute cholecystitis

Laparoscopic cholecystectomy was performed. Gallbladder adhesion score and intraoperative findings of patients were assessed. Adhesion score, gallbladder perforation during the dissection, convertion to open cholecystectomy, operation time, drain usage and intraoperative complications were recorded.

Procedure: Laparoscopic cholecystectomy

Interventions

The technique used for LC was the conventional four-trocar approach (10-mm optic at the umbilicus, 10-mm trocar in the epigastrium and two 5-mm trocars in the right upper abdomen).

Acute cholecystitisChronic cholecystitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 80 cholecystitis patients (40 symptomatic chronic, 40 acute).

You may qualify if:

  • Symptomatic chronic cholelithiasis patients, who were accepted to laparoscopic cholecystectomy
  • Acute cholelithiasis patients, who were accepted to laparoscopic cholecystectomy in first 72-96 hours (from the onset of symptoms), Acute cholecystitis diagnosis was made according to; acute right upper quadrant abdominal pain with positive Murphy's sign, fever, leukocytosis and sonographically; distended GB, presence of gallstones or sludge, GB wall thickness of 3-mm or more, sonographic Murphy's sign.

You may not qualify if:

  • Choledocholithiasis
  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana Numune Education and Research Hospital, Adana, Turkey

Adana, Turkey (Türkiye)

Location

Related Publications (4)

  • Ralls PW, Colletti PM, Lapin SA, Chandrasoma P, Boswell WD Jr, Ngo C, Radin DR, Halls JM. Real-time sonography in suspected acute cholecystitis. Prospective evaluation of primary and secondary signs. Radiology. 1985 Jun;155(3):767-71. doi: 10.1148/radiology.155.3.3890007.

    PMID: 3890007BACKGROUND
  • Uggowitzer M, Kugler C, Schramayer G, Kammerhuber F, Groll R, Hausegger KA, Ratschek M, Quehenberger F. Sonography of acute cholecystitis: comparison of color and power Doppler sonography in detecting a hypervascularized gallbladder wall. AJR Am J Roentgenol. 1997 Mar;168(3):707-12. doi: 10.2214/ajr.168.3.9057520.

    PMID: 9057520BACKGROUND
  • Akoglu M, Ercan M, Bostanci EB, Teke Z, Parlak E. Surgical outcomes of laparoscopic cholecystectomy in scleroatrophic gallbladders. Turk J Gastroenterol. 2011;22(2):183-9. doi: 10.4318/tjg.2011.0188.

    PMID: 21796556BACKGROUND
  • Cetinkunar S, Erdem H, Aktimur R, Soker G, Bozkurt H, Reyhan E, Sozen S, Irkorucu O. Evaluation of power Doppler sonography in acute cholecystitis to predict intraoperative findings: a prospective clinical study. Ulus Travma Acil Cerrahi Derg. 2015 Jan;21(1):51-6. doi: 10.5505/tjtes.2015.64505.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Resected gallbladders pathology

MeSH Terms

Conditions

CholecystitisTissue Adhesions

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Recep Aktimur

    Samsun Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 1, 2014

First Posted

June 5, 2014

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations