Comparison of Outcomes of Circumcision Via Open and Plastibell Methods
Condition: Circumcision, Male
Study type: Interventional

Summary: 
      Circumcision is considered one of the most common elective surgical procedures, particularly
      among Muslim and Jewish males. Of all the available techniques, Plastibell is gaining
      traction amongst surgeons due to its safety in the form of a lower complication rate. The
      current quasi-experimental study aimed to compare the Open and Plastibell methods of
      circumcision in a study population which comprised of boys up to 5 years of age who were
      grouped into the Open method and Plastibell based on parental preference. Follow-up occurred
      on the 5th, 10th, and, 30th post-procedural day. Basic demographic data, procedural duration,
      and outcomes were documented.
    

Detailed description: 
      This study was conducted to compare the Open and Plastibell method of circumcision in boys up
      to 5-years of age, in terms of procedural time, outcomes and parental satisfaction.

      This was a quasi-experimental study of boys up to 5-years of age. Boys meeting the inclusion
      criteria were categorized into two groups based on parental preference - Open method and
      Plastibell. Patients were followed-up on the 5th, 10th and 30th post-procedural day. Basic
      demographic data, procedural duration, and outcomes were documented.

      Of 646 boys brought to the hospital for circumcision, 608 met the inclusion criteria with
      equal participants in both groups. The median age in Open and Plastibell groups was three and
      five months respectively. The median operating time was significantly shorter in the
      Plastibell group (4.2 min) compared to the Open method (13 min). Of the complications
      recorded in 91 children, more were observed in Plastibell group. Post-procedure bleeding
      occurred in 1.2% children (n=7). Open method resulted in infection, excessive skin removal
      (n=8 each) and urinary retention (n=7) whereas Plastibell impaction (n=21) and inadequate
      skin removal (n=19) were the commonest complications in the Plastibell group which were
      significantly associated with age of the boys. There were no serious adverse events. Open
      method was preferred by parents for cosmesis and Plastibell for ease of care.

      It is concluded that Plastibell, compared to open method, is a quicker method of circumcision
      and is safe for boys up to 5-years of age, however, earlier circumcisions are associated with
      lesser complications. The follow-up ensures patient safety.
    

Intervention name(s): Open surgical method; Plastibell method
Intervention type(s): Procedure; Procedure
Intervention description(s): After separating the preputial skin from glans and removing smegma, two artery clips were applied on the dorsal skin in the center to mark the skin to be divided. Crushing the skin for a couple of minutes, prior to incising, helps to reduce bleeding. The skin was cut about 2-3 mm short of the coronal sulcus. Similarly, 2-3 mm cuff of prepuce was circumferentially cut proximal to the corona. Using bipolar diathermy or catgut 4/0, frenular artery along with dorsal artery and vein of penis were coagulated or ligated respectively to achieve hemostasis. The skin and prepuce were approximated and sutured with catgut 4/0 at four places- ventral, dorsal, and two lateral points. Finally, a dressing with antibiotic ointment was applied to the wound.; The prepuce was separated all around the glans, up to the coronal sulcus, and smegma was removed. A dorsal slit in the skin was made, after crushing the skin for a couple of minutes, long enough to accommodate the passage of an appropriate-sized plastibell. Once the distal edge of the bell snugly fit at or near the coronal sulcus, a ligature was applied and tightened around the sulcus on the bell. The extra preputial skin was cut with either scissors or a surgical blade, after breaking apart and discarding the handle of the plastibell. The urethral meatus was examined and its visibility was ensured prior to returning the baby boy to his parents. The baby was kept under observation for 30 minutes in the surgical ward and re-examined to ensure there was no hematoma or bleeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Circumcision; Open method; Plastibell method; Complications; Outcomes; Parental response