Clinical trial · Observational
Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer
Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vaginal Carcinoma | Vaginal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vulvar Carcinoma | Vulvar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaires)
- description
- 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.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (6)
- measure
- Number of surgical complications
- timeFrame
- 4 years
- description
- Will determine whether the number of surgical complications varies by vaginal and bladder reconstruction type.
- measure
- Short-term and long-term complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with contraindications to surgery * Patients unwilling or unable to complete self-administered questionnaires * Patients who do not read or speak English or Spanish
References
Publications (0)
Data not yet available