TRAIL-CC: Trachelectomy, Radical Hysterectomy, and Intimate Life After Cervical Cancer Study
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes
      related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months
      after surgery.
    

Detailed description: 
      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.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women diagnosed with cervical or endometrial cancer
      
Keywords: tracehelectomy; radical hysterectomy