Optimal Timing for Performing Loop Electrosurgical Excision Procedure
Condition: Cervical Precancerous Lesions
Study type: Interventional

Summary: 
      Cervical precancerous lesions (cervical intraepithelial neoplasia) are frequently diagnosed
      and treated in women of reproductive-aged [1]. Loop electrosurgical excision procedure (LEEP)
      is the standard surgical treatment in CIN 2 or 3 [1]. This procedure is an inexpensive, easy
      to learn and provide specimens for pathological examination with the least major surgical
      morbidity [2].

      Although LEEP is a safe procedure, complications such as postoperative bleeding have been
      reported. These haemorrhages make patients anxious, undergo unnecessary follow-ups,
      additional procedures to stop bleeding and interfere in patients daily activities. Various
      interventions have been attempted to prevent and/or reduce perioperative and/or postoperative
      haemorrhage after LEEP including vasopressiın, tranexamic acid, Monsel's solution, or local
      hemostats (TochoSil or Tisseel), but have failed to show a definite advantage over routine
      practice [2-4].

      A hormonal variation during the menstrual cycle is known to affect hemostasis [5] and the
      blood flow of the genital organ [6,7]. A systematic review of the literature through PubMed,
      OvidSP, Google Scholar, and Scopus identified only one previous investigation of menstrual
      cycle period affect blood loss during the LEEP procedure. The authors showed that women had
      less perioperative bleeding during the follicular phase than during the luteal phase [8]. Two
      retrospective studies have also demonstrated rhinoplasty and mammoplasty caused more bleeding
      during the luteal phase and menstruation than during the follicular phase [9,10]. In
      contrast, other retrospective studies have shown no relation between operative blood loss and
      the menstrual cycle for hysterectomy, myomectomy, and ovarian cystectomy [11-13] To answer
      this clinically relevant question, the investigators performed a randomized study comparing
      perioperative and postoperative bleeding between patients underwent LEEP procedure during the
      follicular or luteal phase of the menstrual cycle.
    


Intervention name(s): Vaginal bleeding
Intervention type(s): Other
Intervention description(s): Vaginal bleeding was classified into four categories according to the timing. Intraoperative bleeding (defined as bleeding that occur during the LEEP procedure), early postoperative bleeding (defined as bleeding that occur between end of the LEEP procedure and home discard), late postoperative bleeding (defined as bleeding that occur within two weeks after the home discard, and required hemostatic interventions such as electrocauterization, gauze packing, or cervical suturing, excluding menstrual bleeding), and persistent postoperative bleeding (defined as vaginal bleeding that occurs more than 2 weeks after the procedure with or without required hemostatic interventions, excluding menstrual bleeding).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Loop electrosurgical excision procedure