Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

NCT00909896 | Completed

• 1 other identifier: OSU-08155
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer

Keywords

endometrial; pain

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 hours

Secondary Outcomes (1)

• 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.

  up to 5 years

Study Arms (2)

Robotic Surgery candidates

Group of patients receive Robotic approach for endometrial cancer staging

Open Laparotomy Surgical Candidates

Patients receiving open laparotomy for endometrial cancer surgical staging

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female subjects ages 18-85 years old, Pre operative diagnosis of clinical stage I or II endometrial cancer, Subject able to tolerate use of opioids for pain management, Eastern Cooperative Oncology Group (ECOG)0-3.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Endometrial Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• David Cohn, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: April 8, 2009
• Primary Completion: January 29, 2013
• Study Completion: January 29, 2013
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

US (1)