Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2015-07-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Total or Subtotal Colectomy
all patients who underwent total colectomy(removal of the large intestine from ileum to the rectum. After it is removed, the end of the small intestine is sewn to the rectum) or subtotal colectomy(removal of transverse colon, descending colon, sigmoid colon to the rectum. After it is removed, the end of the ascending colon is sewn to the rectum)as part of optimal cytoreductive surgery
Total or Subtotal Colectomy
Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease \<=0.5cm)
Other Bowel Resection
all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery
Other Bowel Resection
Resect part of the colon or small intestine: with other types of bowel resection as a part of optimal cytoreductive surgery(residual disease \<=0.5cm)
Interventions
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Total or Subtotal Colectomy
Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease \<=0.5cm)
Other Bowel Resection
Resect part of the colon or small intestine: with other types of bowel resection as a part of optimal cytoreductive surgery(residual disease \<=0.5cm)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma with pathology confirmed International Federation of Gynecology and Obstetrics (FIGO) stage IIIc or IV
* Extensive colonic metastasis, tumor involving the major part of bowel surface and/or mesentery
* Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 0.5cm
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* American Society of Anesthesiologists (ASA) performance 1-2.
* Follow-up available.
* Written informed consent.
Exclusion Criteria
* Patient who underwent enterostomy in the surgery procedure.
* Tumor involving small intestine alone.
* More than 2 anastomoses.
* Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
* Prior invasive malignancies within the last 5 years showing activity of disease.
18 Years
75 Years
FEMALE
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Shanghai Gynecologic Oncology Group
OTHER_GOV
Responsible Party
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Principal Investigators
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Rongyu Zang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Shanghai Gynecologic Oncology Group
Other Identifiers
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zsfud-obgyn-004
Identifier Type: -
Identifier Source: org_study_id
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