Safety of Regular Diet as the First Meal in Patients Who Underwent Surgical Treatment for Gynecologic Cancer

NCT00328757 | Withdrawn Phase 3

• 1 other identifier: OF-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether it is safe to give a regular diet as the first postoperative meal in patients who underwent surgical treatment for clinically early-stage gynecologic cancer.

Conditions

Gynecologic Neoplasms

Keywords

gynecologic cancer; cervical cancer; ovarian cancer; endometrial cancer; radical abdominal hysterectomy; pelvic lymphadenectomy; surgical staging; postoperative feeding; Early-stage gynecologic cancer patients

Outcome Measures

Primary Outcomes (1)

• Rate of clinically significant postoperative ileus

Secondary Outcomes (5)

• Patient's satisfaction

• Other postoperative complications

• Time to first flatus

• Amount of meal taken

• Hospital stay

Interventions

Regular diet as the first postoperative meal BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• Clinically early-stage gynecologic cancer patients who underwent standard abdominal surgery as a primary treatment of their diseases

You may not qualify if:

• Peritonitis
• Perioperative hyperalimentation
• Bowel surgery (except appendectomy)
• Bowel obstruction
• History of bowel surgery or inflammatory bowel syndromes
• History of abdominal/pelvic radiotherapy
• Need for continued postoperative endotracheal tube or naso/orogastric tube placement
• Need for postoperative Intensive Care Unit (ICU) administration
• Pregnancy

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Muang Chiangmai, Chiang Mai, 50200, Thailand

Location

Related Publications (3)

• Jeffery KM, Harkins B, Cresci GA, Martindale RG. The clear liquid diet is no longer a necessity in the routine postoperative management of surgical patients. Am Surg. 1996 Mar;62(3):167-70.

  PMID: 8607572 BACKGROUND

• Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. doi: 10.1016/s0029-7844(01)01387-4.

  PMID: 11430967 BACKGROUND

• MacMillan SL, Kammerer-Doak D, Rogers RG, Parker KM. Early feeding and the incidence of gastrointestinal symptoms after major gynecologic surgery. Obstet Gynecol. 2000 Oct;96(4):604-8. doi: 10.1016/s0029-7844(00)00957-1.

  PMID: 11004367 BACKGROUND

MeSH Terms

Conditions

Genital Neoplasms, Female; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Interventions

Diet

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kittipat Charoenkwan, M.D.

  Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: May 1, 2006
• Study Completion: April 1, 2007
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

TH (1)