The Effect of Octreotide on the Duration of Post-mastectomy Wound Drainage: a Randomized Controlled Trial

Study design and location: This was a randomised controlled trial carried out at the University College Hospital Ibadan, a premier teaching hospital in South West Nigeria.

Study population: Study participants were recruited from female breast cancer patients who presented through the Surgery Out-Patient (SOP) clinic of the University College Hospital, Ibadan to these general surgical divisions over the study period.

Sample size determination: Assuming a standard normal deviate (Zα/2) at 5% type I error of 1.96, standard normal variate for power (Zβ, at 80% power) of 0.84, standard deviation of 1.9 to detect a difference in mean duration of drain of 1.7 days, and an attrition rate of 5%, a sample size formula for comparing 2 independent means was used to obtain a total sample size of 41 study participants.

Sampling and randomisation technique: Convenience sampling of breast cancer patients presenting during the study period was employed. Study participants were randomized into 2 groups, a treatment and a control group, using blocked sequence randomization. Consecutive female breast cancer patients were prospectively enrolled in turns into the two study groups via the surgical out-patient department of the University College Hospital, Ibadan over the study period till the required sample size was attained. A computer-generated blocked randomisation sequence was used to insert the instruction "1" or "2" (representing treatment or control groups respectively) consecutively to 30 serially numbered envelopes, all of which were sealed afterwards.

Data collection: Data was obtained through a detailed history and physical examination and includes sociodemographic variables like age, occupation, educational status, religion and tribe. Other pre-operative data obtained included BMI, diagnosis, clinical (TNM) stage, histology, tumor grade, comorbidities and ASA grade. Intra-operative data obtained included cadre of surgeon, length of skin incision, intra-operative blood loss, total number of lymph nodes removed, weight of mastectomy specimen and duration of surgery. Post-operatively, the daily volume of wound drainage, post-operative day of drain and suture removal, total drain volume, time to drain removal, occurrence of seroma formation, frequency and duration of seroma aspirations and total number of positive lymph nodes on histology were recorded. All the above data were entered into a questionnaire proforma.