Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

The primary objective is to measure and compare postoperative pain at rest at several time points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Post operative Quality of Life will also be collected at several time points. The total amount of post operative opioid requirements during the first 24hours between patients undergoing either robotic or open laparotomy approach surgery. The survival status every four months for the first two years will be monitored, then every 6 months for up to 5 years. The primary endpoint is the mean difference in post operative pain VAS scores reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after surgery has been completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female subjects between ages 18-86 years old
Subject provided written consent
Preoperative diagnosis of stage i or II endometrial cancer
Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at The Ohio State University
Subject should be expected to be able to use and tolerate opioids for pain management
Pre operative health is graded as ASA I-III
ECOG(Eastern Cooperative Oncology Group)Performance status 0-3
Subject willing to comply with scheduled visits

Exclusion criteria

Subject is prisoner, pregnant, or under age 18 or over age 85
Hypersensitivity to opioids
subject is breastfeeding
Preoperative Health grade ASA IV-V
ECOG Performance Status 4-5
History of receiving prior chemotherapy or radiation therapy
Subject schedule for additional procedures at the same time as the surgical staging
Subject with pain related illness that to the PI discretion would interfere with study assessments.
Known history of alcohol, analgesic, or narcotic abuse within 12 months.
Subjects taking NSAID(nonsteroidal anti inflammatory drug medications)within 7 days prior to baseline visit.
Require and/or receive chronic analgesic therapy for any pain related condition
Severe acute or chronic medical or psychiatric condition that would interfere with the study results.

Treatment and study plan

Primary outcomes

The outcome measure is mean difference in post operative pain VAS scores reported by subjects at rest at the several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.

Time frame: up to 24 hours

Secondary outcomes

Secondary outcomes will include the measurement of post operative pain after leg extension, post operative quality of life, post operative opioid requirements during first 24hours, survival status up to five years.

Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Prospective, Double Arm, Comparative Study for the Evaluation of Postoperative Pain, QOL, and Determination of Inflammatory Markers In Patients Undergoing Robotics Versus Open Laparotomy Approach for Staging of Endometrial Cancer

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: May 29, 2009
Registry last updated: Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed