Feeding Schedules After Surgery in Patients With Gynecologic Cancer

NCT00742677 | Unknown

• 2 other identifiers: CDR0000612328IEO-S328/506
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Reproductive Cancer

Keywords

female reproductive cancer

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

Secondary Outcomes (6)

• 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

Study Arms (2)

Group 1 (early feeding)

EXPERIMENTAL

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

Group 2 (traditional feeding)

ACTIVE COMPARATOR

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

Interventions

nutritional support PROCEDURE

Given orally

Group 1 (early feeding); Group 2 (traditional feeding)

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Interventions

Nutritional Support

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Lucas Minig, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

• Roberto Biffi, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

• Angelo Maggioni, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Last Updated: September 20, 2013

Record last verified: 2009-07

Locations

IT (1)