Trial Information

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

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.