Design: Randomized controlled trial

Setting: University-based medical center (OR, clinic)

Patients or Participants: This is a preliminary report from the “APEX trial” (NCT05174988). Eligible participants were between ages of 18-60 undergoing laparoscopic hysterectomy for benign indications. Patients were excluded if scheduled for concomitant pelvic floor repair/vaginal procedures (USLS, MUS, etc.), or if final pathology revealed malignancy.

Interventions: Patients were randomized to either undergo vaginal cuff closure with figure-of-eight stitches at each angle using 0-polyglactin, and single-layer barbed suture from right to left for the remaining portion (APEX group), vs single layer closure with barbed suture from right to left (CONTROL group). Allocation was revealed to surgeon after completion of hysterectomy, before cuff closure, and all closures were performed by MIGS trained surgeons. A standardized survey was given to patients by blinded research staff between 10-25 days postop inquiring about the subjective quantification of vaginal bleeding after surgery. Patients remained blinded to allocation.

Measurements and Main Results: 42 patients were included in the APEX group and 50 in the CONTROL group (n=92). Groups were similar in terms of age (43.6 v 44.4 p=.62) and BMI (35.0 v 33.1 p=.30). Diabetes was more prevalent in APEX group (23.0% v 8%). There was no difference in the presence of postoperative vaginal bleeding between groups (35.7% v 30% p=.56). Out of these, 60% in the APEX group and 40% in the CONTROL group reported bleeding as “Daily” or “Most days”. Cuff closure time in seconds was significantly higher in the APEX group (816.07s v 516.64s, p=.02). There was one reoperation for cuff dehiscence in the APEX group.

Conclusion: Separately closing vaginal cuff angles after laparoscopic hysterectomy does not reduce postoperative bleeding, and takes on average an additional 5 minutes of operative time.