Condition category
Surgery
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barry Wright

ORCID ID

Contact details

31 Shipton Road
York
YO30 5RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6719

Study information

Scientific title

Serotonin transporter gene polymorphisms as a predictor of recovery after laporoscopic cholecystectomy: a non-randomised interventional screening trial

Acronym

Study hypothesis

Recovery from surgery is highly variable. Having a better understanding of factors affecting this is useful in planning surgery, monitoring the effects of surgery and in conducting further research to improve recovery for future patients. Research has found that psychosocial factors, particularly attitudinal and mood factors, were strongly predictive of surgical outcomes, even after accounting for known clinical factors.

Work is underway to find biological markers for outcomes in major surgery, but there are currently no known biological markers identified for good or poor psychosocial recovery to date. However, the serotonin transporter gene polymorphism represents a possible marker. The promotor region of the serotonin transporter gene is present as homozygous (two short, ss, or two long, ll alleles) or heterozygous. Numerous studies have found that following a major life event, depression was more likely to occur in individuals carrying the short allele (ss, sl).

The aim of the present study is to investigate whether the serotonin transporter gene polymorphism is related to psychosocial recovery after a common operation, laparoscopic cholecystectomy. To do this, we will assess the polymorphic status of 250 individuals due to have laparoscopic cholecystectomy and give them a range of self report questionnaires to fill in before the surgery and 6 weeks after.

Ethics approval

York Research Ethics Committee, 29/08/2007, ref: 07/H1311/69

Study design

Non-randomised interventional screening trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Service Delivery; Disease: Not Applicable

Intervention

1. Buccal swab - taken before the operation an analysed for the serotonin gene length polymorphism only
2. Questionnaires - filled in by participants before the operation and 6 weeks after: 2.1. 36-item short form health survey (SF-36)
2.2. Hospital Anxiety and Depression Scale (HAD)
2.3. Beck Depression Inventory (BDI)
2.4. Chalder Fatigue Scale
2.5. Visual Analogue Pain Scale
2.6. Eysenck Personality Questionnaire (EPQ-R)
2.7. Unvalidated questionnaire on pre- and post-operative milestones (e.g. time back to work etc)

Follow up length: 12 months

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Change in score on the Beck Depression Inventory (BDI), scored on a scale of 0 - 63, measured on day before operation and 6 weeks after.

Secondary outcome measures

1. Change in scores on Health Anxiety and Depression (HAD) questionnaire, Chalder's Fatigue Scale, Eysenck Personality Questionnaire - Revised and 36-item short form health survey (SF-36), measured on day before operation and 6 weeks after
2. Visual Analogue Scale (VAS), measured day after operation and 6 weeks after
3. Unvalidated questionnaire to assess current health, measured before operation
4. Unvalidated questionnaire to assess common post-operative milestones, measured 6 weeks after operation

Overall trial start date

01/01/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing elective laparoscopic cholecystectomy
2. Male and female, aged 18 - 65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 250; UK Sample Size: 250

Participant exclusion criteria

Patients undergoing open laporoscopic cholecystectomy

Recruitment start date

01/01/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

31 Shipton Road
York
YO30 5RE
United Kingdom

Sponsor information

Organisation

York Hospitals NHS Foundation Trust (UK)

Sponsor details

Learning and Research Centre
Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor type

Government

Website

http://www.york.nhs.uk/

Funders

Funder type

Charity

Funder name

BUPA Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/08/2016: No publications found, verifying study status with principal investigator.