Serotonin transporter gene as predictor of recovery after surgery
| ISRCTN | ISRCTN40219584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40219584 |
| Secondary identifying numbers | 6719 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 21/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Barry Wright
Scientific
Scientific
31 Shipton Road
York
YO30 5RE
United Kingdom
Study information
| Study design | Non-randomised interventional screening trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Serotonin transporter gene polymorphisms as a predictor of recovery after laporoscopic cholecystectomy: a non-randomised interventional screening trial |
| Study objectives | 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(s) | York Research Ethics Committee, 29/08/2007, ref: 07/H1311/69 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Key inclusion criteria | 1. Patients undergoing elective laparoscopic cholecystectomy 2. Male and female, aged 18 - 65 years |
| Key exclusion criteria | Patients undergoing open laporoscopic cholecystectomy |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
31 Shipton Road
York
YO30 5RE
United Kingdom
YO30 5RE
United Kingdom
Sponsor information
York Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Learning and Research Centre
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Website | http://www.york.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Charity
BUPA Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/09/2016 | Yes | No |
Editorial Notes
21/02/2018: Publication reference added.
02/08/2016: No publications found, verifying study status with principal investigator.
