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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, Ioannina University Hospital, Ioannina, Greece; and the Academic Unit of Obstetrics and Gynaecology, St. Mary’s Hospital, Manchester, United Kingdom.
Address reprint requests to: Evangelos Paraskevaidis, MD, Department of Gynecology, Ioannina University Hospital, 45001 Ioannina, Greece; E-mail: vangelispar{at}hotmail.com.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: A randomized controlled trial was carried out to compare the outcomes in terms of primary and secondary hemorrhage between patients treated by loop electro-surgical excision procedure during either the follicular (30 women) or luteal phase (30 women) of the menstrual cycle. The two groups did not differ in terms of mean age, grade of cervical intraepithelial neoplasia, depth of excision, parity, and duration of menses. Primary outcome measures included the objective and subjective assessment of intra-operative and postoperative bleeding.
RESULTS: Women treated during the luteal phase of the menstrual cycle experienced significantly more postoperative bleeding than women treated during the follicular phase, as assessed by the fall in hematocrit levels (P < .001) and subjective reports. Intraoperative bleeding was judged to be more severe in women treated during the luteal phase of the cycle by a single, blinded colposcopist (P = .02). These women also experienced higher levels of anxiety postoperatively, which resulted in more consultations with medical staff (P = .007).
CONCLUSION: The use of loop electrosurgical excision procedure to treat cervical intraepithelial neoplasia results in less bleeding if performed during the follicular phase of the menstrual cycle.
Over the last decade, loop electrosurgical excision procedure (LEEP) has become the most popular treatment technique for cervical intraepithelial neoplasia.1–4 It is an outpatient procedure performed under local anesthetic, which produces a pathologic specimen for histologic diagnosis. It is a safe and simple technique with few complications. Intraoperative bleeding is usually adequately controlled by diathermy. Postoperative (secondary) bleeding is less predictable in terms of onset, duration, and severity, and there are no established criteria to predict which patients are at risk.5,6
The aim of this study was to determine whether treatment in the follicular or luteal phase of the menstrual cycle affects perioperative or postoperative bleeding rates. We designed a prospective, randomized trial to compare the outcomes in terms of primary and secondary bleeding between patients treated during either the follicular or luteal phase of the menstrual cycle.
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MATERIALS AND METHODS |
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The patients were randomly allocated to one of two groups using computer-generated random numbers using the Excel Software (Microsoft) by the colposcopy reception before their colposcopic evaluation. We estimated that 30 patients completing the trial per group would result in a power of 80% if there was a difference of 30% between the two groups and if 
were .05. The power estimation was based on categoric parameters (difference of frequencies).
In the first study group (A), treatment was undertaken during the follicular phase between days 4–6, whereas in the second group (B), treatment was undertaken during the luteal phase between days 16–18. After colposcopic assessment, the patients requiring treatment were asked to keep a menstrual diary recording details about the duration and severity of bleeding and pain experienced during menstruation for the next 2 months. Women were instructed to call during their second menstruation so a precise date for treatment could be arranged according to their group allocation. Immediately before treatment, a full blood count (hematocrit 1) was taken. The colposcopist carrying out treatment was blinded to the patient’s group allocation. Only one colposcopist performed the treatment to reduce intraobserver subjective variations in quantifying the degree of blood loss. Then, LEEP was carried out according to standard practice, and the depth of excision was measured with a ruler on the excised specimen. Diathermy cauterization to the edge of the crater was performed in all patients irrespective of intraoperative bleeding to achieve hemostasis and to ensure homogenicity in both groups. Diathermy to the new cervical os was avoided as this has been shown to reduce the risk of cervical stenosis and unsatisfactory colposcopy after treatment.7
Intraoperative bleeding was recorded as minimal, moderate, or severe by the colposcopist. When there was no bleeding at all or just one bleeding point, it was considered minimal. When there were up to three bleeding points, it was recorded as moderate, and when all edges of the crater bled or large vessels continued to bleed despite initial diathermy, it was judged as severe. The difficulty experienced in controlling the bleeding was graded as minimal (if it required less than 2 minutes of diathermy to adequately control the bleeding and diathermy the crater) and moderate/severe (if more than 2 minutes of diathermy was necessary to stop the bleeding and diathermy the crater). Women were given standard advice about avoiding strenuous physical exercise over the next few days and abstaining from sexual intercourse for the next month. They were advised that bleeding postoperatively was common and to expect some blood loss for up to 1 month after treatment. In addition, they were informed that their subsequent menstruation might be heavier than usual. Patients were asked to complete a diary over the next 3 months recording information about blood loss, paying particular attention to the first postoperative month. They were asked to describe bleeding as heavy, more than usual menstrual blood loss, moderate, similar to normal menstrual loss, and mild, less than usual menstrual loss. These included the days of their next menstrual period. Data about discomfort, anxiety, days off work, and consultations with medical staff were also recorded. Anxiety was assessed by the woman’s need to consult the medical staff of the department for reassurance either by phone or by visiting the department postoperatively. Patients returned to the clinic 1 month after treatment for a full blood count (hematocrit 2) and 2 months later for combined cytologic and colposcopic evaluation.
A 
2 test was used to compare categoric parameters between the two groups (including intraoperative bleeding and anxiety levels). A two-tailed Student t test was used to compare continuous parameters between the two groups (such as days of postoperative bleeding and hematocrit levels).
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RESULTS |
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). One woman from group B returned 10 days after treatment with fresh heavy blood loss and was found to have an oozing blood vessel that required repeat diathermy. Two other women from the same group had small hematomas on the ectocervix that proved to be endometriotic islands in punch biopsies. In three women from group A and two from group B, a deeper pass was done because of endocervically extended lesion.
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). These women also experienced higher levels of anxiety postoperatively (P = .007). Intraoperative bleeding as assessed by the colposcopist was also judged to be more severe in women treated during the luteal phase of the cycle (P = .02). The results in both groups are shown in Table 2.
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DISCUSSION |
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In this study, women treated during the luteal phase of the menstrual cycle experienced significantly more postoperative bleeding than women treated during the follicular phase as assessed by blood count (P < .001) and subjective reports (P <.001). Women in this group experienced higher levels of anxiety regarding the amount of blood loss, which in turn resulted in a higher number of consultations with medical staff (P =.007). From the colposcopist’s point of view, intraoperative bleeding was also more severe in women treated during the luteal phase of the cycle compared with those treated during the follicular phase (P =.02). Diathermy cauterization to control bleeding during treatment was judged to be equally effective in both groups. The increased blood loss in the women treated in the luteal phase did not have any effect on their hemodynamic condition, and is therefore not clinically important. It caused, however, more anxiety and discomfort to the patients and more hospital visits.
The reason for increased rates of secondary hemorrhage in women treated during the luteal phase of the menstrual cycle is not clear. There was no difference in the depth of excision between the two groups.11 All patients received diathermy cauterization to the cervical crater walls and edges to achieve standardized short-term hemostasis. This may also help to smooth the irregular walls of the crater, resulting in more symmetric healing. Such a practice may also destroy residual islands of dysplastic epithelium, leading to higher rates of curative resection of cervical lesions.12 The use of diathermy may explain the low levels of bleeding in the intraoperative period.
A recent study showed the vaginal and pelvic microvessels exhibit increased vascular reactivity during the follicular phase of the menstrual cycle.13 We speculate that after the diathermy, debris may become dislodge from the cervical crater several days after treatment. The more reactive microvessels in the cervix during the follicular phase of the menstrual cycle may contract and produce better hemostasis than the less reactive vessels in the luteal phase.
Although the precise cause of different bleeding rates in women treated during the two phases of the menstrual cycle remain speculative, the results of this study suggest that it is preferable to perform LEEP during the follicular phase of the menstrual cycle.
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Footnotes |
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Received September 10, 2001. Received in revised form February 4, 2002. Accepted February 21, 2002.
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REFERENCES |
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2. Gunasekera PC, Phipps JM, Lewis DV. Large loop excision of the transformation zone (LLETZ) compared to carbon dioxide laser in the treatment of CIN: A superior mode of treatment. Br J Obstet Gynaecol 1990;97:995–8.[Medline]
3. Martin-Hirsch PL, Paraskevaidis E, Kitchener H. Surgery for cervical intraepithelial neoplasia. Cochrane Database Syst Rev 2000.
4. Turner MJ, Rasmussen MJ, Flannelly GM, Kelehan P, Lenehan PM, Murphy JF. Outpatient loop diathermy conization as an alternative to inpatient knife conization of the cervix. J Reprod Med 1992;37:314–6.[Medline]
5. Prendiville W. Large loop excision of the transformation zone. A practical guide to LLETZ. 1st ed. Chapman & Hall Medical, 1993.
6. Bigrigg A. Overview of clinical experience to date. Large loop excision of the transformation zone. A practical guide to LLETZ. 1st ed. Chapman & Hall Medical, 1993.
7. Paraskevaidis E, Koliopoulos G, Paschopoulos M, Stefanidis K, Navrozoglou I, Lolis D. Effects of ball cauterization following loop excision and follow up colposcopy. Obstet Gynecol 2001;97:618–20.
8. Robinson WR, Webb S, Tirpack J, Degetu S, Q’Quinn AG. Management of cervical intraepithelial neoplasia during pregnancy with loop excision. Gynecol Oncol 1997; 64:153–5.[Medline]
9. Luesley DM, Cullimore J, Redman CWE, Lawton FG, et al. Loop diathermy excision of the cervical transformation zone in patients with abnormal cervical smears. Br Med J 1990;300:1690–3.
10. Murdoch JB, Grimshaw RN, Monaghan JM. Loop diathermy excision of the abnormal cervical transformation zone. Int J Gynecol Cancer 1991;1:105–11.
11. Luesley DM, Mc Crum A, Terry PB, Wade-Evans T, Nicholson HO, Mylotte MJ, et al. Complications of cone biopsy related to dimensions of the cone and the influence of prior colposcopic assessment. Br J Obstet Gynaecol 1985;92:158–64.[Medline]
12. Bar-Am A, Daniel Y, Ron IG, Niv J, Kupferminc MJ, Bornstein J, et al. Combined colposcopy, loop conization, and laser vaporization reduces recurrent abnormal cytology and residual disease in cervical dysplasia. Gynecol Oncol 2000;78:47–51.[Medline]
13. Emmanuel AV, Kamm MA, Beard RW. Reproducible assessment of vaginal and rectal mucosal and skin blood flow: Laser doppler fluximetry of the pelvic microcirculation. Clin Sci Colch 2000;98:201–7.[Medline]
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