Subfertility PCOS Morbid obesity Bariatric surgery Life style modification
Conditions
Interventions
Bariatric surgery, Laparoscopic gastric bypass
Sponsors
J.S.E. Laven, MD, PhD
Erasmus Medical Center
Department of Department of Reproductive Endocrinology
3000 CA Rotterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: • Age 18-40 years • BMI > 35 kg/m2. • Subfertile women with PCOS according to the Rotterdam criteria. • No previous fertility treatment. • Psychological screening. • Informed consent and willingness to participate in the follow up program.
Exclusion criteria
Exclusion criteria: • Azoospermia, endometriosis AFS class > III, WHO class III anovulation (premature ovarian failure) or endocrinopathies (such as Cushing syndrome, adrenal hyperplasia and diabetes type I). • Pregnancy induced hypertension, preeclampsia, eclampsia or HELPP syndrome in a previous pregnancy. • Prior fertility treatment. • Prior bariatric surgery. • Prior major abdominal surgery (like colonic resection, septic abdomen, aorta surgery, which might jeopardise the possibility of execution a LSG or LRYGB) • ASA (American Society for Anesthesiologists) classification ≥ IV • Alcohol or drug abuse • Severe concomitant disease (carcinomas, neurodegenerative disorders or other disorders presently representing being considered exclusion criteria for bariatric surgery ) • The inability to understand written information, necessary to give informed consent and to complete questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the rate of healthy born baby rate after at least 37 weeks of gestation (primary end point) within three years after therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Perinatal outcome and complications, percentage of women needing fertility treatment, clinical and ongoing pregnancy rates, loss of excess body weight (%EWL), improvement in obesity induced co-morbidity (MS), biochemical and hormonal changes, quality of life and medical and non-medical costs, obesity related co-morbidity as well as psychosocial performance will improve more after intervention.  Operating time, duration of hospital stay, direct health care costs, peri-operative and post-operative in-hospital mortality and morbidity following LRYGB. Morbidity is defined as reoperations, re-interventions/ reoperations, re-admissions, re-do surgery and serious adverse events. Morbidity is defined as mayor (anastomotic leakage, major peroperative blood loss due to splenic or vascular hemorrhage, pulmonary embolism, intra-abdominal abscess and intra-abdominal hematoma) or minor (wound infection, urinary tract infection and anastomotic stenosis). Moreover, the rate of extra outpatient and ER visits because of complaints following LRYGB are evaluated. To evaluate the need for re-do surgery (need to perform an additional bariatric procedure after the performed surgery) as a result of insufficient weight loss or medical complaints within 5 years following the primary bariatric procedure (LSG or LRYGB). To evaluate the biochemical and hormonal changes following Laparoscopic Roux-en-Y Gastric Bypass or Laparoscopic sleeve gastrectomy. Validated Questionnaires to evaluate quality of life (QoL) following LRYGB: 1) EuroQol-5D (EQ-5D) 2) Short-form 36 (SF-36) and 3) Obesity related Quality of life the Moorehead-Ardelt II questionnaires / Bariatric Analysis and Reporting Outcome System (BAROS). | — |
Contacts
Public ContactR.M.F. Weiden, van der
Department of Obstetrics and Gynecology Sint Franciscus Gasthuis Kleiweg 500
Outcome results
None listed