Clinical trial NCT00742677: Feeding Schedules After Surgery in Patients With Gynecologic Cancer
Official title: Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Reproductive Cancer
Keywords: female reproductive cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-08-28
Enrollment: 180
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Length of hospital stay
Secondary outcomes:
measure: 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)
measure: Degree of postoperative abdominal pain
measure: Global postoperative patient satisfaction
measure: Quality of life using the EORTC OV-28 and EORTC QLQ-C30 questionnaires at baseline and at day 30
measure: Postoperative requirement of antiemetic and analgesic medication
measure: Postoperative complications
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Lucas Minig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Roberto Biffi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Angelo Maggioni, MD
role: PRINCIPAL_INVESTIGATOR
References: