BAMBINI: Bariatric surgery vs Medical care for obesity and polycystic ovarian syndrome related infertility
| ISRCTN | ISRCTN16668711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16668711 |
| IRAS number | 269196 |
| Secondary identifying numbers | 1.0, IRAS 269196, CPMS 43641 |
- Submission date
- 22/01/2020
- Registration date
- 11/02/2020
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Polycystic ovary syndrome (PCOS) is a common condition that affects how a woman's ovaries work. It is characterised by elevated circulating levels of androgens, problems with ovulation and polycystic ovaries. Difficulty with child bearing is a major cause of emotional distress. Approximately 50% of women with PCOS are overweight or obese and this further impacts on fertility. Weight loss through any means is an effective treatment for improving subfertility in this group of women. Lifestyle modification including healthy eating and increased physical activity is effective in causing short term weight loss but is difficult to maintain long term. Medications also have a positive but modest impact on weight loss. Modern key hole (laparoscopic) surgery is one of the safest operations in the field of surgery and obesity surgery causes significant weight loss. Currently obesity surgery is considered an experimental therapy in women with PCOS for the purpose of having a healthy baby. This study aims to change clinical practice by being the first randomised control trial to compare standard medical care to obesity surgery in women with PCOS, obesity and oligo (irregular) or amenorrhea (absent periods).
Who can participate?
Pre-menopausal women 18 years and older with a BMI ≥ 35 kg/m² with obesity related complications and a diagnosis of PCOS. Participants will need to be within travelling distance of either Imperial College Healthcare NHS trust hospitals (London) or University Hospitals Coventry & Warwickshire NHS Trust (Coventry). This is important due to the need for weekly blood tests and monthly clinical reviews (added 11/03/2020).
What does the study involve?
Participants will be randomly allocated to receive either obesity surgery or standard medical care following review by a trained psychologist (part of standard medical care). Following the intervention, follow-up will be for 12 months and involve weekly progesterone blood tests and monthly clinical review. Trial participants are asked to use non-hormonal contraception for the duration of the trial. Following completion of the trial, women in the standard care group will be given the option for referral for obesity surgery.
What are the possible benefits and risks of participating?
Possible benefits: significant weight loss leading to more regular periods. Also regular contact with a specialist.
Risk: obesity surgery sleeve gastrectomy - common risks bleeding, infection, vitamin deficiencies. Will be explained further in detail by the surgical team. Less common risks include a "leak" (leaking of food from the connections made during surgery), a blood clot in the legs or lung, and weight regain. Very rare risks include malnutrition and death.
The lifestyle modification programme is safe and risk-free.
Where is the study run from?
1. Imperial College Healthcare NHS Trust (UK)
2. University Hospitals Coventry and Warwickshire NHS Trust (UK)
When is the study starting and how long is it expected to run for?
February 2020 to April 2023
Who is funding the study?
1. JP Moulton Charitable Foundation, UK
2. National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Dr Suhaniya Samarasinghe (public)
suhaniya.samarasinghe@nhs.net
2. Dr Alexander Miras
a.miras@nhs.net
Contact information
Public
NIHR Imperial CRF
Imperial Centre for Translational and Experimental Medicine
Imperial College Healthcare NHS Trust
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)2033138070 |
|---|---|
| suhaniya.samarasinghe@nhs.net |
Scientific
NIHR Imperial CRF
Imperial Centre for Translational and Experimental Medicine
Imperial College Healthcare NHS Trust
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)2033138070 |
|---|---|
| a.miras@nhs.net |
Study information
| Study design | Multicentre open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Bariatric surgery vs Medical care for obesity and polycystic ovarian syndrome related infertility |
| Study acronym | BAMBINI |
| Study hypothesis | Obesity surgery will be superior to standard medical care in increasing the number of ovulatory cycles in women with PCOS, obesity and oligo or amenorrhoea. |
| Ethics approval(s) | Approved 10/12/2019, London - Dulwich Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)207 104 8052; NRESCommittee.London-Dulwich@nhs.net), ref: 19/LO/1540 |
| Condition | Polycystic ovarian syndrome, obesity |
| Intervention | Patients will be randomised at a ratio of 1:1, stratified by BMI and trial site (using an online randomisation tool). Intervention - obesity surgery Control - standard medical care Participants will be assessed during a screening visit to check that they meet the inclusion criteria for the trial. They will be provided with further written information at this stage. Successful participants will be randomly allocated to either obesity surgery or standard medical care following review by a trained psychologist (part of standard medical care). Following the intervention, follow-up will be for 12 months and involve weekly progesterone blood tests and monthly clinical review. Trial participants are asked to use non-hormonal contraception for the duration of the trial. Following the completion of the trial, women in the standard care group will be given the option for referral for obesity surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 20/02/2023: Number of ovulatory cycles within the 12 months follow-up period - defined as a rise in serum progesterone ≥16 nmol/L, measured using weekly blood progesterone levels Previous primary outcome measure: Number of ovulatory cycles within the 12 months follow-up period - defined as a rise in serum progesterone >20 nmol/L, measured using menstrual diaries and weekly blood progesterone levels |
| Secondary outcome measures | Current secondary outcome measures as of 20/02/2023: Measured at baseline and then monthly for 12 months (except oral glucose tolerance test): 1. Reproductive profile, liver function tests, lipid profile, HbA1C using blood test 2. Severity of anxiety and depression symptoms measured using the hospital anxiety and depression score (HADS) 3. Multidimensional health profile: health functioning questionnaire score, social functioning questionnaire score, PCOS health-related quality of life score, modified Ferriman-Galwey hirsuitism score, Ludwig visual score, Savin Alopecia Scale score, Cardiff Acne Disability Index 4. Arterial blood pressure (mmHg) 5. Oral glucose tolerance test (at baseline, 6 months and 12 months) 6. Body weight (kg) 7. Waist circumference (cm) 8. Body composition 9. Number of medications measured using patient records 10. Adverse events measured using patient records 11. Pregnancy rates measured using patient records Previous secondary outcome measures: Measured at baseline and then monthly for 12 months (except oral glucose tolerance test): 1. Reproductive profile, liver function tests, lipid profile, HbA1C using blood test 2. Mental health measured using the Hospital anxiety and depression scale 3. Multidimensional health profile: health functioning questionnaire score, social functioning questionnaire score, PCOS health-related quality of life score, modified Ferriman-Galwey hirsuitism score, Ludwig visual score, Savin Alopecia Scale score, Cardiff Acne Disability Index 4. Arterial blood pressure (mmHg) 5. Oral glucose tolerance test (only baseline and 6 months) 6. Body weight (kg) 7. Waist circumference (cm) 8. Body composition 9. Number of medications measured using patient records 10. Adverse events measured using patient records 11. Pregnancy rates measured using patient records |
| Overall study start date | 01/11/2019 |
| Overall study end date | 17/04/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Participant inclusion criteria | Current inclusion criteria as of 20/02/2023: 1. Pre-menopausal women 18 years and older 2. BMI more than or equal to 35 kg/m² with obesity-related complications 3. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018 Previous inclusion criteria: 1. Pre-menopausal women 18 years and older 2. BMI more than or equal to 35 kg/m² 3. Obesity-related complications 4. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018 5. Polycystic ovaries on ultrasound |
| Participant exclusion criteria | 1. Type 1 or 2 diabetes mellitus 2. Specific contraindications to obesity surgery 3. Previous obesity surgery 4. Inability to maintain adequate contraception 5. Use of medications affecting reproductive function at screening/3 months prior 6. Other causes of anovulation 7. Current pregnancy/breastfeeding 8. Any medical/psychological/other condition which would potentially either interfere with the study or cause harm to the volunteer 9. Without access at home to a telephone or other factor likely to interfere with the ability to participate reliably in the study |
| Recruitment start date | 20/02/2020 |
| Recruitment end date | 01/02/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Du Cane Road
London
W12 0HS
United Kingdom
Coventry
CV2 2DX
United Kingdom
Sponsor information
University/education
Joint Research Compliance Office
Imperial College London and Imperial College Healthcare NHS Trust
Room 215, Level 2, Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)207 5949459 |
|---|---|
| jrco@ic.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | All publications and presentations relating to the study will be authorised by the Trial Management Group. The first publication of the trial results will be in the name of the Trial Management Group, if this does not conflict with the journal’s policy. If there are named authors, these will include at least the trial’s Chief Investigator, Statistician and Trial Coordinator. Members of the TMG and the Data Monitoring Committee will be listed and contributors will be cited by name if published in a journal where this does not conflict with the journal’s policy. Authorship of parallel studies initiated outside of the Trial Management Group will be according to the individuals involved in the project. The results are likely to be published within the 12 months following the study in peer-reviewed journals and websites, and presented in medical conferences. Participant confidentiality will be ensured at all times and they will not be identified in any publication as these will be anonymised. A lay summary of the key results from the study will be written and sent and/or presented to them. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 4.0 | 05/10/2021 | 29/09/2022 | No | No |
| Statistical Analysis Plan | 23/11/2022 | 05/04/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 20/05/2024 | 04/06/2024 | Yes | No |
Additional files
Editorial Notes
04/06/2024: Publication reference added.
29/08/2023: The intention to publish date was changed from 31/08/2023 to 30/11/2023.
16/06/2023: The intention to publish date was changed from 31/05/2023 to 31/08/2023.
05/04/2023: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The intention to publish date was changed from 01/05/2023 to 31/05/2023.
16/03/2023: The overall end date was changed from 20/03/2023 to 17/04/2023.
21/02/2023: The recruitment start date was changed from 01/02/2020 to 20/02/2020.
20/02/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/02/2023 to 20/03/2023.
2. The primary and secondary outcome measures and inclusion criteria were updated.
29/09/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer reviewed).
2. Total final enrolment added.
3. The overall trial end date was changed from 01/05/2022 to 01/02/2023.
12/08/2020: recruitment has resumed.
05/08/2020: The following changes have been made:
1. The recruitment end date has been changed from 01/08/2020 to 01/02/2021.
2. The overall trial end date has been changed from 01/11/2021 to 01/05/2022.
3. The intention to publish date has been changed from 01/11/2022 to 01/05/2023.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
11/03/2020: The plain English summary was updated.
06/02/2020: Trial’s existence confirmed by London - Dulwich Research Ethics Committee
