Feeding Schedules After Surgery in Patients With Gynecologic Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Female Reproductive Cancer
• Intervention / Treatment: Procedure: nutritional support

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20141
    • European Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 light regular diet until hospital discharge.	Procedure: nutritional support; Given orally
Active Comparator: 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 (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; Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of hospital stay

Secondary Outcome Measures

Outcome Measure
Postoperative complications
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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Lucas Minig, MD, European Institute of Oncology; Principal Investigator: Angelo Maggioni, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): March 1, 2008

Study Registration Dates

• First Submitted: August 27, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: female reproductive cancer
• Other Study ID Numbers: CDR0000612328; IEO-S328/506