Feeding Schedules After Surgery in Patients With Gynecologic Cancer

Female Reproductive Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00742677
• Other study ID #: CDR0000612328
• Secondary ID: IEO-S328/506
• Status: Active, not recruiting
• Phase: N/A
• First received: August 27, 2008
• Last updated: September 19, 2013
• Start date: January 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Female Reproductive Cancer

Intervention

Procedure:
• nutritional support
Given orally

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay			No
Secondary	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)			No
Secondary	Degree of postoperative abdominal pain			No
Secondary	Global postoperative patient satisfaction			No
Secondary	Quality of life using the EORTC OV-28 and EORTC QLQ-C30 questionnaires at baseline and at day 30			No
Secondary	Postoperative requirement of antiemetic and analgesic medication			No
Secondary	Postoperative complications			No