Study setting and participants
We carried out the study at two private not-for-profit hospitals (Mengo hospital and Kibuli hospital) and one government public health centre (Kisenyi Health center IV). These facilities are all located in Uganda’s capital city, Kampala and routinely carry out MMC as part of their services. The circumcision services are offered as outpatient procedures on a walk-in basis. In this study, we included participants who were aged 13 years and above. We excluded those with co-morbidities including sickle cell anemia, diabetes mellitus, history of hypertrophic scars or keloids, those receiving chemotherapy, bleeding disorders and severe penile anomalies like hypospadias.
Study design
This was a prospective observational study carried out from September 2013 to February 2014. We prospectively observed and followed up 274 males who had circumcisions during the study period. Participants were monitored for 2 hours post-surgery and they were evaluated at 24 hours, at 3 days and after one week to assess for adverse events. Direct observation was employed in assessing the complications of circumcision. Males who came to the health facilities for circumcision during the study period were consecutively recruited. Circumcisions in the facilities were done by the cadres who routinely conduct these procedures in the facilities. And these included medical doctors, nurses, clinical officers and orthopedic officers. The complications which were assessed at follow up were bleeding and sepsis following the operation at 2 hours, 24 hours, 3 days, and 7 days (one week) intervals. Direct observation was employed to assess the outcome and phone calls if no complications occurred in the first 24 hours. Direct observation of the procedure was done by [HM] who was at the time a postgraduate student undertaking her master’s degree in surgery. HM conducted the observation and follow up of the participants working together with research assistants. To evaluate time taken to conduct the surgical procedure, a stop clock was used. Timing using the stop clock was started from the time of applying the antiseptic solution to the surgical site and ended after the wound dressing was applied. The comparison was made between medical officers versus non doctor health workers. Outcome variables assessed were bleeding and sepsis following circumcision. All participants who required medical care were referred to their clinical care team at the respective hospitals for management.
Data analysis
Data was entered using Epi data version 3.1. Frequencies and percentages for categorical measures/variables were generated and stratified by circumcision cadre (Medical doctors and non-doctor health workers). Means (standard deviations) and Medians (interquartile ranges [IQR]) for continuous measures/variables were generated. Chi-square or Fisher’s exact test was used to measure association between categorical variables whereas the Student t-test and Kruskal Wallis test were used on continuous variables. The logistic regression model was used to measure factors associated with adverse events at univariate level. A patient/participant was regarded as having an adverse event if they experienced any of the following: post-surgical bleeding, evidence of glans amputation, evidence of excessive skin removal, evidence of urethral injury, fever post-surgery and evidence of pus discharge post circumcision. Statistical analysis was performed using SAS Enterprise Guide 7.1.