Feeding Schedules After Surgery in Patients With Gynecologic Cancer

European Institute of Oncology

Status: Unknown

Conditions: Female Reproductive Cancer

Treatments: Procedure: nutritional support

Study type: Interventional

Funder types: Other

Identifiers

NCT00742677

CDR0000612328

IEO-S328/506

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

180 participants in 2 patient groups

Group 1 (early feeding)

Experimental group

Description:

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.

Treatment:

Procedure: nutritional support

Group 2 (traditional feeding)

Active Comparator group

Description:

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.

Treatment:

Procedure: nutritional support