Trial Outcomes & Findings for Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery (NCT NCT00757484)

Results Overview

491 women were included in analysis. Measure is categorized by the type of surgery.

Recruitment status

COMPLETED

Target enrollment

528 participants

Primary outcome timeframe

January 2007 to January 2008

Results posted on

2015-12-17

Participant Flow

This was a chart review study. 37 participants were not analyzed because the data in their chart was not available.

Participant milestones

Participant milestones
Measure	Women Who Underwent Gynecologic Surgery All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
Overall Study STARTED	491
Overall Study COMPLETED	491
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women Who Underwent Gyneologic Surgery n=491 Participants All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	491 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	491 participants n=5 Participants
Postmenopausal	169 participants n=5 Participants
Hypertension	163 participants n=5 Participants
Diabetes	26 participants n=5 Participants
Gastroesophageal Reflux Disease	185 participants n=5 Participants
depression/anxiety	159 participants n=5 Participants

PRIMARY outcome

Timeframe: January 2007 to January 2008

Population: 491 women were included in analysis.

491 women were included in analysis. Measure is categorized by the type of surgery.

Outcome measures

Outcome measures
Measure	Women Who Underwent Scheduled Gynecologic Surgery n=491 Participants All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
Percentage of Participants Who Underwent Gynecologic Surgery abdominal	42 percentage of participants
Percentage of Participants Who Underwent Gynecologic Surgery laparoscopic	32 percentage of participants
Percentage of Participants Who Underwent Gynecologic Surgery vaginal	26 percentage of participants

SECONDARY outcome

Timeframe: 1 year

% women with asymptomatic hypotension

Outcome measures

Outcome measures
Measure	Women Who Underwent Scheduled Gynecologic Surgery n=491 Participants All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
Percentage of Women With Asymptomatic Hypotension < 65 years of age	22.8 percentage of participants
Percentage of Women With Asymptomatic Hypotension 65 years or older	17.7 percentage of participants

SECONDARY outcome

Timeframe: January 2007 to January 2008

Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).

Outcome measures

Outcome measures
Measure	Women Who Underwent Scheduled Gynecologic Surgery n=491 Participants All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
Percentage of Participants Undergoing Different Types of Anesthesia general	92 percentage of participants
Percentage of Participants Undergoing Different Types of Anesthesia local	4 percentage of participants
Percentage of Participants Undergoing Different Types of Anesthesia LO-MAC	6 percentage of participants

SECONDARY outcome

Timeframe: January 2007 to January 2008

Length of surgery

Outcome measures

Outcome measures
Measure	Women Who Underwent Scheduled Gynecologic Surgery n=491 Participants All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
Surgical Time	146 minutes Interval 12.0 to 420.0

Adverse Events

Women Who Underwent Gynecologic Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Duecy

University of Rochester Medical Center

Phone: 585-275-4004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place