Feeding Schedules After Surgery in Patients With Gynecologic Cancer

NCT ID: NCT00742677

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief 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.

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.

Conditions

Female Reproductive Cancer

Keywords

female reproductive cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Study Groups

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.

Group Type: EXPERIMENTAL

nutritional support

Intervention Type: PROCEDURE

Given orally

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.

Group Type: ACTIVE_COMPARATOR

nutritional support

Intervention Type: PROCEDURE

Given orally

Interventions

nutritional support

Given orally

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Principal Investigators

Lucas Minig, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Roberto Biffi, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Angelo Maggioni, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Countries

Italy

Other Identifiers

IEO-S328/506

Identifier Type: -

Identifier Source: secondary_id

CDR0000612328

Identifier Type: -

Identifier Source: org_study_id