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临床试验/NCT00742677
NCT00742677Unknown不适用

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

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
2
主要终点
Length of hospital stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Supportive Care

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Length of hospital stay

次要结局

  • 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
  • Postoperative complications

研究者

发起方
European Institute of Oncology
申办方类型
Other

研究点 (2)

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