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临床试验/NCT03952975
NCT03952975已完成不适用

Optimal Timing for Performing Loop Electrosurgical Excision Procedure According to Different Menstrual Phase: Which is Best?

Erzincan Military Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
mean early postoperative blood loss

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women was ≥ 21 years old
  • Women was not pregnant
  • Women were not menstruating or menopausal status
  • Women with the normal regular menstrual cycle (defined as an interval between 21 and 35 days and duration between 3 and 10 days)
  • Women had one of the following indications for LEEP procedure
  • a histology-proven, persistent, low grade squamous intraepithelial lesions (LGSIL),
  • a histology-proven high-grade squamous intraepithelial lesions (HGSIL),
  • discrepancies between cytological reports and colposcopic impressions,
  • investigation for unsatisfactory colposcopy,
  • micro invasion or adenocarcinoma in situ on cervical punch biopsy

排除标准

  • Women with cervical or vaginal infection,
  • Women with the abnormal menstrual cycle,
  • Women taking any medication (or injection) such as oral contraceptives, GnRH agonist, medroxyprogesterone acetate, or anticoagulants
  • Women with coagulation defect,
  • Women with mental incapacity,
  • Women with a history of neurologic deficit,
  • Women with previous hysterectomy with removal of the cervix,
  • Women with a history of cervical cancer

研究组 & 干预措施

follicular phase group

Other

The menstrual dates of patients were normalized to a 28-day cycle with the following formula: adjusted day of the menstrual cycle = (14 X day of the cycle at the time of surgery) / (cycle length of the patient - 14). In light of this formula patients were classified into the follicular phase group (defined as <15 adjusted days, group A).

干预措施: Vaginal bleeding (Other)

luteal phase group

Other

The menstrual dates of patients were normalized to a 28-day cycle with the following formula: adjusted day of the menstrual cycle = (14 X day of the cycle at the time of surgery) / (cycle length of the patient - 14) [14]. In light of this formula, patients were classified into the luteal phase group (defined as ≥15 adjusted days, group B).

干预措施: Vaginal bleeding (Other)

结局指标

主要结局

mean early postoperative blood loss

时间窗: 6 hours

Estimated early postoperative blood loss was calculated using the difference in hematocrit values taken after LEEP procedure and 6 hours after procedure, according to the following formula: Estimated Blood Loss = estimated blood volume X (hematocrit 1 - hematocrit 2)/hematocrit 1, where the estimated blood volume in milliliters = woman's weight in kilograms X 85

次要结局

  • the rate of late postoperative bleeding(bleeding that occur within four weeks after the home dischard)
  • mean intraoperative bleeding(During the LEEP procedure)

研究者

发起方
Erzincan Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kemal GUNGORDUK

Principal Investigator

Erzincan Military Hospital

研究点 (2)

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