NCT02810860

Brief Summary

Collection of PROMs (Patient Reported Outcome Measures) data from patients before and after an operation to remove their gallbladder for the treatment of symptomatic gallstones. This PROMs data will provide information to clinicians and trusts about the health gain following this type of surgery and the impact on patient's quality of life. This information will be collected by the implementation of the patient Website aboutmyop.org. This will not only allow patients to complete quality of life (PROMs) questionnaires online, but will also allow them to access information on their condition and necessary surgery, in addition to post-operative follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration 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

April 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 20, 2020

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

April 25, 2016

Last Update Submit

February 18, 2020

Conditions

Gallstone Disease

Keywords

laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Mean domain PROMs scores for each study participant

    We will look at the change in score between: pre--op and 30-Days, Pre-op and 3 Months post-op and pre-op and 6 months post-op. For this analysis we hope to use the paired t---test, however depending on whether the data is normally distributed or not this may require non---parametric analyses with the Wilcoxon rank---sum test. We also aim to look at the overall trend, which will require analysis of variance.

    30-Days,3 Months and 6 Months

Secondary Outcomes (3)

  • Completion of the Multimedia Informed Consent package on aboutmyop.org

    30 days

  • Completion of the 7---Day follow---up questionnaire.

    7 days

  • Completion of a Patient Satisfaction Survey to receive feedback on the process.

    6 months

Study Arms (1)

Open Label

OTHER

Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy

Open Label

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female.
  • Adults:aged 18 to 85 years.
  • Be referred for consideration for an elective laparoscopic cholecystectomy for symptomatic gallstones based on their GPs diagnosis and referral to a general surgeon.
  • Patients initially listed for laparoscopic cholecystectomy but subsequently converted to open cholecystectomy or subsequently have a more complex 'biliary' procedure (including but not exclusive to bile duct exploration, biliary drain insertion, biliary bypass procedure).

You may not qualify if:

  • Patients unable to, or those choosing not to engage with the multimedia process --- including patients lacking mental capacity, patients who do not have access to a multimedia device (including but not exclusive to a computer, tablet or multimedia phone), patients who are unable to use a multimedia device unassisted.
  • Patients who are unable to read or communicate n English without the presence of a translator.
  • Patients undergoing another major non---biliary operation during the same operation as their cholecystectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Related Publications (1)

  • Daliya P, Carvell J, Rozentals J, Lobo DN, Parsons SL. Digital Follow-Up After Elective Laparoscopic Cholecystectomy: A Feasibility Study. World J Surg. 2022 Nov;46(11):2648-2658. doi: 10.1007/s00268-022-06684-w. Epub 2022 Aug 11.

    PMID: 35953737DERIVED

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Prita Daliya, MBChB, MRCS, PGDip(Hons)

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

June 23, 2016

Study Start

August 18, 2016

Primary Completion

April 13, 2018

Study Completion

January 1, 2019

Last Updated

February 20, 2020

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)