Clinical trial NCT03952975: Optimal Timing for Performing Loop Electrosurgical Excision Procedure
Official title: Optimal Timing for Performing Loop Electrosurgical Excision Procedure According to Different Menstrual Phase: Which is Best?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Precancerous Lesions
Keywords: Loop electrosurgical excision procedure
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Women was ≥ 21 years old
2. Women was not pregnant
3. Women were not menstruating or menopausal status
4. Women with the normal regular menstrual cycle (defined as an interval between 21 and 35 days and duration between 3 and 10 days)
5. Women had one of the following indications for LEEP procedure

   1. a histology-proven, persistent, low grade squamous intraepithelial lesions (LGSIL),
   2. a histology-proven high-grade squamous intraepithelial lesions (HGSIL),
   3. discrepancies between cytological reports and colposcopic impressions,
   4. investigation for unsatisfactory colposcopy,
   5. micro invasion or adenocarcinoma in situ on cervical punch biopsy

Exclusion Criteria:

* 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

Primary outcomes:
measure: mean early postoperative blood loss
timeFrame: 6 hours
Secondary outcomes:
measure: mean intraoperative bleeding
timeFrame: During the LEEP procedure
measure: the rate of late postoperative bleeding
timeFrame: bleeding that occur within four weeks after the home dischard
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Kemal Gungorduk
Study officials:
References:
citation: Paraskevaidis E, Davidson EJ, Koliopoulos G, Alamanos Y, Lolis E, Martin-Hirsch P. Bleeding after loop electrosurgical excision procedure performed in either the follicular or luteal phase of the menstrual cycle: a randomized trial. Obstet Gynecol. 2002 Jun;99(6):997-1000. doi: 10.1016/s0029-7844(02)02003-3.