HPOS: Hormonal Predictors of Oncologic Surgery

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02471157
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

An observational trial to determine whether preoperative hormonal status predicts outcomes of oncologic surgery.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Other: Observation

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Association of Hypogonadism and Post-operative Outcomes of Oncologic Surgery
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Eugonadal Eugonadal men	Other: Observation
Hypogonadal Hypogonadal men	Other: Observation

Outcome Measures

Primary Outcome Measures

1. Length of Stay [6 days, on average]

   Length of post-operative stay

2. Complication rate, post-operative [6 days, on average]

   Complication rate during initial postoperative period

3. Complication rate, 30 day [30 days]

   Complication rate during the initial 30 days after surgery

4. Complication rate, 90 days [90 days]

   Complication rate during the initial 90 days after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing above surgery for cancer

Exclusion Criteria:

• Started hormonal replacement in past two months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Douglas Scherr, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02471157
• Other Study ID Numbers: 1408015434
• First Posted: Jun 15, 2015
• Last Update Posted: Jan 25, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Hypogonadism

Study Results

No Results Posted as of Jan 25, 2019