Feeding Schedules After Surgery in Patients With Gynecologic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To investigate the relationship between the different policies of realimentation (early oral feedings versus traditional feedings) and the length of hospital stay following a laparotomy in patients with gynecologic oncologic disease. To assess the degree of postoperative abdominal pain in these patients. To evaluate the incidence of ileus symptoms, including nausea and vomiting, and the postoperative recovery of intestinal activity in these patients. To determine the incidence of postoperative complications in these patients. To elucidate the global postoperative patient's satisfaction and the quality of life in both groups of patients. 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. Group 1 (early feeding): 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 regular diet until hospital discharge. Group 2 (traditional feeding): 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 (i.e., no 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. 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.

Official Title
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Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial

Conditions
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Female Reproductive Cancer

Intervention / Treatment
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* Procedure: nutritional support


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Preoperative diagnosis for probable gynecologic pathology No benign pathology or final histopathology diagnosis confirmed as non-gynecologic disease Admitted to the European Institute of Oncology Elected to undergo laparotomic surgery No total or anterior pelvic exenteration No emergency laparotomy PATIENT CHARACTERISTICS: No metabolic pathology (e.g., diabetes mellitus type I) No preoperative ASA score ≥ 4 No preoperative infection No severe malnutrition (weight loss > 10% within the past 3 months) No preoperative intestinal obstruction No postoperative admission to the intensive care unit (ICU) for more than 24 hours No severe concomitant medical condition PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior abdominal and/or pelvis radiotherapy

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (early feeding)<br>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. | Procedure: nutritional support<br>* Given orally<br>|
| Active Comparator: Group 2 (traditional feeding)<br>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. | Procedure: nutritional support<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female reproductive cancer