Trial Information

Improvements in our treatment of these cancers has resulted in an increased focus on quality
of life issues. Sexual health is one such important aspect of quality of life that is often
disrupted in cervical cancer survivors. However, currently there are no established
treatments for such sexual problems, often leaving women and their partners with long-term
difficulties that interfere in other aspects of their relationship and lives.

Treatment of cervical cancer involves hysterectomy (i.e. removal of the uterus), and
commonly bilateral salpingo-oophorectomy (BSO; i.e. bilateral removal of the ovaries and
fallopian tubes). Hysterectomy results in direct physical consequences to sexual function
which have been attributed to probable autonomic nerve damage (Butler-Manuel et al., 2000;
2002; Weijmar Schultz et al., 1991). Depending on the extent of disease, hysterectomy may
be either simple (i.e. surgical removal of the uterus without excision of adjoining tissue)
or radical (i.e. surgical removal of the uterus, the parametria and uterosacral ligaments,
the upper portion of the vagina, and the pelvic lymph nodes).

In the last two decades, a new procedure known as trachelectomy, has surfaced to treat early
stages of cervical cancer. Unlike radical hysterectomy, the trachelectomy procedure aims to
preserve the fertility in young women who wish to have children post cervical cancer and
treatment (Plante et al., 2004; 2005). This preservation of fertility in trachelectomy is a
result of leaving the patient's uterus intact while removing the cervix, parametrium and
upper one third of the vagina. With the uterus intact, the patients are capable of
conceiving multiple births post-procedure (Bernardini et al., 2003, Plante et al., 2004;
2005), an option that was not present in the past for women after radical hysterectomy.

The few dozen studies done looking at the outcomes of trachelectomy have mainly focused on
medical outcomes such as fertility and cancer cure and recurrence. The findings show there
is a 70-72% success rate in women who try to conceive post-trachelectomy (Boss et al., 2005,
Plante et al., 2005). If a patient is eligible for a trachelectomy procedure, according to
the criteria (Sonoda et al., 2004), recurrence-free survival is excellent at 95% (Plante et
al., 2004).

With such improvements in the identification and cure of cervical cancer and the use of
fertility-sparing techniques, there has been an increase in the number of young patients in
remission, raising a number of quality of life issues. Sexual health is recognized as an
integral aspect of quality of life during survivorship and is increasingly receiving
research and clinical attention (Juraskova et al., 2003; Wenzel et al., 2002). In the
studies done on trachelectomy we find that there are a handful of women who, prior to the
operation, wish to conceive a child, but post-operation lose this desire and do not try to
conceive (Boss et al., 2005, Plante et al., 2005), but no further studies have been done in
this area as to the reasons why. Although the studies have been very beneficial for medical
information none of the studies examining the efficacy of trachelectomy have studied the
impact on sexual health or quality of life. On the other hand, research on the effects of
radical hysterectomy in women with cervical cancer finds approximately half of women
experience negative sexual side-effects such as significantly more lubrication difficulties,
reduced vaginal length and elasticity, and marked distress (Bergmark et al., 1999). Also
distressing to 36% of the women in this group is the absence of genital swelling in more
than half of their sexual encounters, despite no changes in sexual frequency or orgasmic
experience (Bergmark et al., 1999). When a vaginal photoplethysmograph was used to document
changes in genital blood flow (an indirect measure of sexual arousal), women with radical
hysterectomy had more impairment in blood flow responses than either a control group or a
simple hysterectomy group, suggesting involvement of autonomic nerves (Maas et al., 2002).

Given that women, together with their partners and oncologists, may find themselves in a
position of selecting one procedure over another, it seems important to better understand
the relative effects of these procedures on intimate life and sexual health. The objective
of this study, therefore, is to compare radical hysterectomy with trachelectomy in the
effects on intimacy, sexual health, and mood immediately before, 1 month after, and 6 months
after surgery.

This study will help to identify patterns and outcomes on these aspects of quality of life
in hopes of better informing women of the potential outcomes of their procedures. Cervical
cancer and treatment are life-altering events; therefore it is desirable to identify and
hopefully reduce any negative psychological and physical sequelae of treatment. We want to
ensure that problems related to post-cervical cancer are diminished so that the survivor's
quality of life can be maintained at an acceptable level, allowing the patients to continue
living a fulfilling life, uninhibited by sexual and emotional distress.