Optimal Timing for Performing Loop Electrosurgical Excision Procedure

NCT03952975 | Completed DMC

• 1 other identifier: MUGLA SKU
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Precancerous Lesions

Keywords

Loop electrosurgical excision procedure

Outcome Measures

Primary Outcomes (1)

• mean early postoperative blood loss

  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

  6 hours

Secondary Outcomes (2)

• mean intraoperative bleeding

  During the LEEP procedure

• the rate of late postoperative bleeding

  bleeding that occur within four weeks after the home dischard

Study Arms (2)

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).

Other: Vaginal bleeding

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).

Other: Vaginal bleeding

Interventions

Vaginal bleeding OTHER

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).

follicular phase group; luteal phase group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Kemal Gungorduk

Muğla, 35460, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 12052589 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 16, 2019
• Study Start: May 20, 2019
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)