Accelerating Gastrointestinal Recovery

Study Overview
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Brief Summary
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This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Official Title
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Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: Alvimopan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Females at least 18 years of age Have an American Society of Anesthesiologists (ASA) Score of I to III Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer Are scheduled to have their nasogastric tube removed before the first postoperative dose of study medication Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent Exclusion criteria: Females younger than 18 years of age Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian, tubal, or peritoneal cancer. Have taken more than 7 consecutive days of therapeutic doses of opioids immediately prior to surgery Use illicit drugs or abuse alcohol Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous bowel movements per week) or chronic diarrhea Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled surgery Have chemotherapy or radiation induced bowel dysfunction Are pregnant (identified by a positive urine or serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence) Have participated in another investigational drug or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study Have clinically significant laboratory abnormalities at screening that would result in the cancellation of surgery Have a diagnosis of severe hepatic insufficiency or end stage renal disease. Have a history of previous surgeries, illness, or behavior that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures Are unable to understand the study procedures and are not able to voluntarily provided informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alvimopan<br>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. | Drug: Alvimopan<br>* Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.<br>* Other names: Entereg;|
| Placebo Comparator: Placebo<br>Perioperative administration of placebo, at same dosing interval as study drug. | Drug: Placebo<br>* Perioperative administration of placebo, at same dosing interval as study drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Length of Hospital Stay | Length of stay = date/time of hospital dismissal - date/time of end of surgery | Patients will be followed for the duration of their hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Ileus Incidence | Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus. | Patients will be followed for 30 days postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovary, Ovarian, Fallopian, Peritoneal, Cancer, Gynecological, Female