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| ID | Type | Description | Link |
|---|---|---|---|
| IEO-S328/506 |
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RATIONALE: Abdominal pain and nausea and vomiting may be lessened by waiting after surgery before eating foods by mouth. It is not yet known which feeding schedule is more effective in patients undergoing surgery.
PURPOSE: This randomized clinical trial is comparing two feeding schedules after laparotomy in patients with gynecologic cancer.
OBJECTIVES:
Primary
OUTLINE: Patients are stratified according to laparotomy with or without intestinal resection (yes vs no), and presence of ovarian cancer (yes vs no). Patients are randomized to 1 of 2 groups at the end of surgery.
Data is collected through the Post-Operative Pain Questionnaire, Bowel Function Table, Global Postoperative Patient's Satisfaction Questionnaire, Postoperative Complication and Hospital Stay Questionnaire, and the Quality of Life Questionnaires EORTC OV-28 and EORTC QLQ-C30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (early feeding) | Experimental | Patients are offered a liquid diet on day 1 for 24 hours following surgery. Beginning on day 2, patients who tolerate a liquid diet are offered a light regular diet until hospital discharge. |
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| Group 2 (traditional feeding) | Active Comparator | Patients are offered nothing by mouth on days 1 and 2 following surgery. Beginning on day 3, patients are offered a liquid diet for 24 hours. Beginning on day 4, patients who tolerate a liquid diet (absence of nausea and vomiting) are offered a semi-solid diet for 24 hours. Beginning on day 5, patients who tolerate a semi-solid diet are offered a light regular diet until hospital discharge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional support | Procedure | Given orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptoms of postoperative ileus (e.g., nausea, vomiting, time to feel intestinal activity, time to passage of flatus, and time to bowel movement) | ||
| Degree of postoperative abdominal pain |
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DISEASE CHARACTERISTICS:
Preoperative diagnosis for probable gynecologic pathology
Admitted to the European Institute of Oncology
Elected to undergo laparotomic surgery
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas Minig, MD | European Institute of Oncology | Principal Investigator |
| Roberto Biffi, MD | European Institute of Oncology | Principal Investigator |
| Angelo Maggioni, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D018529 | Nutritional Support |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Global postoperative patient satisfaction |
| Quality of life using the EORTC OV-28 and EORTC QLQ-C30 questionnaires at baseline and at day 30 |
| Postoperative requirement of antiemetic and analgesic medication |
| Postoperative complications |