Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Number of surgical complications
研究概览
简要总结
The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the types of complications experienced by women who undergo pelvic exenteration at University of Texas (UT) MD Anderson Cancer Center.
II. To determine whether the number of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center differ by vaginal and bladder reconstruction types.
SECONDARY OBJECTIVES:
I. To evaluate pathologic predictors of recurrence including histology, size of tumor, and distance of closest margin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology
- •Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy
- •Patients must be suitable candidates for surgery (in case of prospective collection)
- •Patients who have signed an approved informed consent
- •Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease
- •Women must be able to read and write in either Spanish or English
排除标准
- •Patients with contraindications to surgery
- •Patients unwilling or unable to complete self-administered questionnaires
- •Patients who do not read or speak English or Spanish
研究组 & 干预措施
Observational (questionnaires)
RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires.
PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.
干预措施: Quality-of-Life Assessment (Other)
Observational (questionnaires)
RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires.
PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Number of surgical complications
时间窗: 4 years
Will determine whether the number of surgical complications varies by vaginal and bladder reconstruction type.
Recurrence
时间窗: Up to 5 years
Will calculate median time to recurrence in patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of recurrence such as histology, size of tumor, and distance of closest margin.
Short-term and long-term complications
时间窗: 4 years
Will calculate incidence with exact 95% confidence intervals, and will calculate summary statistics. Will create the statistics using both cohorts of patients together. Will also do this separately by cohort and by vaginal reconstruction type as well as by bladder reconstruction type. A Wilcoxon rank-sum test will be used to determine whether there is a difference in number of complications by vaginal reconstruction type and by bladder reconstruction type. This will be conducted separately for each cohort. Finally, will create a Poisson regression model using both cohorts of patients with terms for cohort, vaginal reconstruction type and bladder reconstruction type as well as certain preoperative factors (albumin, electrolyte levels, body mass index) that might be predictive of number of complications.
Quality of life
时间窗: Up to 5 years
Will summarize composite scores of the quality of life surveys by time from exenteration. This will be done separately for the retrospectively recruited patients and the prospectively recruited patients. Will also summarize information by year of surgery. To determine how quality of life changes over time, will create longitudinal models for each survey instrument given to the women. The two cohorts of women will initially be analyzed separately. A second model will be created using all patients that has terms for cohort, vaginal reconstruction type and bladder reconstruction type to determine whether these terms have an effect upon quality of life.
Overall survival
时间窗: Up to 5 years
Will calculate overall survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.
Disease-free survival
时间窗: Up to 5 years
Will calculate disease-free survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.
次要结局
未报告次要终点