Serotonin transporter gene as predictor of recovery after surgery

ISRCTN	ISRCTN40219584
DOI	https://doi.org/10.1186/ISRCTN40219584
Protocol serial number	6719
Sponsor	York Hospitals NHS Foundation Trust (UK)
Funder	BUPA Foundation (UK)

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

31 Shipton Road
York
YO30 5RE
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised interventional screening trial
Secondary study design	Non randomised study
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

31 Shipton Road

York
YO30 5RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/02/2018: Publication reference added.
02/08/2016: No publications found, verifying study status with principal investigator.