Protocol for an observational study investigating hormones triggering the onset of sustained lactation: the INSIGHT study.

INTRODUCTION: Lactation is a hormonally controlled process that promotes infant growth and neurodevelopment and reduces the long-term maternal risk of diabetes, cardiovascular disease and breast cancer. Hormones, such as prolactin and progesterone, mediate mammary development during pregnancy and are critical for initiating copious milk secretion within 24-72 hours post partum. However, the hormone concentrations mediating lactation onset are ill defined. METHODS AND ANALYSIS: The primary objective of the investigating hormones triggering the onset of sustained lactation study is to establish reference intervals for the circulating hormone concentrations initiating postpartum milk secretion. The study will also assess how maternal factors such as parity, pregnancy comorbidities and complications during labour and delivery, which are known to delay lactation, may affect hormone concentrations. This single-centre observational study will recruit up to 1068 pregnant women over a 3-year period. A baseline blood sample will be obtained at 36 weeks' gestation. Participants will be monitored during postpartum days 1-4. Lactation onset will be reported using a validated breast fullness scale. Blood samples will be collected before and after a breastfeed on up to two occasions per day during postpartum days 1-4. Colostrum, milk and spot urine samples will be obtained on a single occasion. Serum hormone reference intervals will be calculated as mean±1.96 SD, with 90% CIs determined for the upper and lower reference limits. Differences in hormone values between healthy breastfeeding women and those at risk of delayed onset of lactation will be assessed by repeated measures two-way analysis of variance or a mixed linear model. Correlations between serum hormone concentrations and milk composition and volume will provide insights into the endocrine regulation of milk synthesis. ETHICS AND DISSEMINATION: Approval for this study had been granted by the East of England-Cambridgeshire and Hertfordshire Research Ethics Committee (REC No. 20/EE/0172), by the Health Research Authority (HRA), and by the Oxford University Hospitals National Health Service Foundation Trust. The findings will be published in high-ranking journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN12667795.

Laparoscopic compared with open adrenalectomy for resection of pheochromocytoma: a review of 47 cases.

OBJECTIVE: We conducted a retrospective cohort study to determine whether laparoscopic adrenalectomy (LA) is a safe and effective therapy for the management of pheochromocytoma, as compared with open adrenalectomy (OA). METHODS: We collected pertinent data on 47 pheochromocytoma resections from 44 patient charts. Perioperative outcomes of 30 LAs were compared with 14 OAs. RESULTS: Median (and standard deviation [SD]) length of postoperative stay was shorter in the laparoscopic group (3.0, SD 3.3 d v. 6.0, SD 1.1 d; p < 0.05), and tumour size was smaller (3.9, SD 2.7 cm v. 5.0, SD 2.9 cm; p < 0.05). No statistically significant differences were found for operative time or rate of postoperative complications. There were no statistically significant between-group differences in intraoperative hypertensive episodes (systolic blood pressure > 180 and/or diastolic blood pressure > 90) or hypotensive episodes (systolic blood pressure < 100 and/or diastolic blood pressure < 60) or in the need for antihypertensive or vasopressive agents. There were no intraoperative complications related to extremes of blood pressure. There were no perioperative mortalities in this series, nor was there an increased risk of recurrent disease with the laparoscopic technique. CONCLUSION: LA is safe and effective for the management of pheochromocytoma.