A comparison between forceps-guided and stapler-assisted circumcision in adult phimosis: procedure time and 3-month changes in penile length, sexual function and vibratory sensitivity - a randomised trial
Phimosis
Patients were recruited consecutively and randomized in a 1:1 ratio using the National Cancer Institute Clinical Trial Randomization Tool - MTI method: maximal (National Cancer Institute. Clinical Trial Randomization Tool. https://ctrandomization.cancer.gov [accessed 18 March 2024]). The allocation sequence was generated in advance and stored in a secure, password-protected format accessible only to a study team member not involved in the eligibility assessment or surgery. Treatment assignment was obtained sequentially only after eligibility confirmation and the completion of baseline assessments. Circumcisions were performed under local anaesthesia using 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%, administered circumferentially at the base of the penis. CircC technique: The device size was selected individually based on the penile circumference measured with the manufacturer-provided tape to ensure an appropriate fit of the glans-protective bell and stapling ring. Following frenuloplasty, a glans-protective bell was inserted beneath the foreskin. In instances where the preputial opening was constricted, a dorsal incision was made to facilitate insertion. Once the bell was positioned, the CircCurer™ device was applied and activated, simultaneously cutting and inserting the metal staples. Haemostasis was verified, and a pressure dressing was applied to manage the bleeding. FGC technique: Following frenuloplasty, the foreskin was grasped with two forceps to standardise traction, and a third transverse forceps was used as the cutting guide. The prepuce was excised distal to the clamp using a scalpel, haemostasis was obtained with bipolar cautery, and the skin edges were approximated with interrupted rapidly absorbable sutures, consistent with standard forceps-guided descriptions. Postoperatively, all patients were observed for several hours and discharged on the same day with instructions on penile elevation, twice-daily dressing changes, wound disinfect
1. Male sex 2. Age ≥18 years 3. Clinical diagnosis of pathological phimosis requiring circumcision 4. Ability to provide written informed consent 5. Willingness to complete the planned follow-up visits
1. Active genital infection or balanoposthitis at the time of surgery 2. Suspected penile malignancy requiring broader oncological management 3. Known allergy to local anaesthetic 4. Contraindication to local anaesthetic