Overview

This trial is active, not recruiting.

Condition female reproductive cancer
Treatment nutritional support
Sponsor European Institute of Oncology
Start date January 2007
End date March 2008
Trial size 180 participants
Trial identifier NCT00742677, CDR0000612328, IEO-S328/506

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose supportive care
Arm
(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.
nutritional support
Given orally
(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.
nutritional support
Given orally

Primary Outcomes

Measure
Length of hospital stay
time frame:

Secondary Outcomes

Measure
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)
time frame:
Degree of postoperative abdominal pain
time frame:
Global postoperative patient satisfaction
time frame:
Quality of life using the EORTC OV-28 and EORTC QLQ-C30 questionnaires at baseline and at day 30
time frame:
Postoperative requirement of antiemetic and analgesic medication
time frame:
Postoperative complications
time frame:

Eligibility Criteria

Female participants up to 75 years old.

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

Additional Information

Official title Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial
Principal investigator Lucas Minig, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).