To compare sexual functioning and complaints concerning micturation and defecation in women after abdominal or vaginal trachelectomy for early stage cervical cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sexual functioning and complaints of micturation and defecation according to
the validated questionnaires.
Secondary outcome
NA
Background summary
Sexual, micturation and defecation disorders are well known postoperative
complaints following radical hysterectomy in women with cervical cancer. Damage
to the autonomic innervation of bladder, rectum and vagina (the hypogastric
nerve and plexus) may be the leading cause of these disorders. Maas et al
showed significant damage to the autonomic nerves in conventional radical
hysterectomy at the cleavage site of the sacro-uterine ligament. Yabuki et al
were the first to perform a nerve sparring radical hysterectomy. This modified
radical hysterectomy appears to be safe in the sense of disease free survival.
Following nerve sparring surgery women have significantly less urinary
complaints and Pieterse showed that the vaginal response on sexual stimulation
(as an objective measure of function of the hypogastric nerve) is less impaired
after nerve sparring radical hysterectomy when compared to women after
conventional radical hysterectomy.
Radical trachelectomy can be used to treat women with early stage cervical
cancer who wish to preserve fertility because the uterine body is left in situ
while the uterine cervix with surrounding tissue as in radical hysterectomy
(including sacro-uterine ligament with the hypogastric nerve and plexus). This
surgical procedure can be performed vaginally or abdominally. In case of
abdominal trachelectomy the autonomic nerves can be saved as in nerve sparring
radical hysterectomy, while in vaginal trachelectomy it is not possible to
selectively save the autonomic nerves. Until now it is unclear if there is a
difference in sexual functioning and complaints concerning micturation and
defecation after abdominal versus vaginal trachelectomy. In theory abdominal
trachelectomy saves the autonomic nerves and this may result in less
complaints. On the other hand vaginal trachelectomy may not damage the
autonomic nerves because of different approach as compared to the abdominal
route, moreover vaginal trachelectomy results in less intraabdominal adhesions
and does not leave a large surgical scar on the abdomen with possible negative
effect on self-esteem en sexual functioning.
Study objective
To compare sexual functioning and complaints concerning micturation and
defecation in women after abdominal or vaginal trachelectomy for early stage
cervical cancer.
Study design
The study is a questionnaire - study. Women who underwent abdominal or vaginal
trachelectomy will be asked to participate. Participating women are asked to
fill out three validated questionnaires: EORTC QLQ-C30 (cancer specific quality
of life questionnaire, EORTC QLQ-CX24 (cervical cancer specific quality of life
questionnaire and the Gynecologic Leiden Questionnaire (cervical cancer
specific questionnaire for sexual and pelvic floor symptoms). Copyright holding
authorities have approved the use of the questionnaires. The results of the
questionnaires will be compared according to surgical procedure.
Study burden and risks
No risk, minimal burden (3 questionnaires, approx 30 minutes) with possible
quality of life benefit for women who need to be treated for early stage
cervical cancer and wish to preserve fertility.
Albinusdreef 2
2300 RC Leiden
Nederland
Albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Early stage cervical cancer (FIGO stage 1a-1B1)
Abdominal or vaginal trachelectomy
Exclusion criteria
Adjuvant therapy (eg radiation therapy and /or chemotherapie)
Local recurrance and / or distant metastasis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30837.058.09 |