Trial Outcomes & Findings for Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (NCT NCT01124916)

Last Updated: 2017-01-04

Results Overview

At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

6 Weeks

Results posted on

2017-01-04

Participant Flow

The recruitment period was from November 2009 to August 2011 (21 months)

Following enrollment, six women withdrew prior to randomization and two women were lost to follow-up prior to randomization

Participant milestones

Participant milestones
Measure	Laparoscopic Abdominal Sacrocolpopexy (LASC) Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)	Robotic Assisted Laparoscopic (RASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Overall Study STARTED	38	40
Overall Study COMPLETED	35	38
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Laparoscopic Abdominal Sacrocolpopexy (LASC) Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)	Robotic Assisted Laparoscopic (RASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Abdominal Sacrocolpopexy (LASC) n=38 Participants Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)	Robotic Assisted Laparoscopic (RASC) n=40 Participants Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)	Total n=78 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 9.2 • n=5 Participants	58.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	59.5 years STANDARD_DEVIATION 9.9 • n=5 Participants
Gender Female	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
City and state where the study activities took place Maywood, Illinois	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
City and state where the study activities took place Los Angeles, California	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Body Mass Index (BMI)	27 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	28.2 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	27.7 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants
Parity	2.7 Count of pregnancies STANDARD_DEVIATION 1.3 • n=5 Participants	2.6 Count of pregnancies STANDARD_DEVIATION 1.1 • n=7 Participants	2.7 Count of pregnancies STANDARD_DEVIATION 1.2 • n=5 Participants
Years of Education 12 or fewer years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Years of Education More than 12 years	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Net household income Less than $50,000	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Net household income $50,000 to $75,000	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Net household income More than $75,000	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Net household income Unknown	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Comorbid Diabetes No	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Comorbid Diabetes Yes	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
History of Heart Attack No	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
History of Heart Attack Yes	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
History of Stroke No	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
History of Stroke Yes	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
History of Cancer No	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
History of Cancer Yes	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
History of Stomach Ulcer No	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
History of Stomach Ulcer Yes	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Postmenopausal No	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Postmenopausal Yes	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Concomitant estrogen therapy No	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Concomitant estrogen therapy Yes	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Previous surgery for urinary incontinence No	31 Participants n=5 Participants	35 Participants n=7 Participants	66 Participants n=5 Participants
Previous surgery for urinary incontinence Yes	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Previous surgery for pelvic organ prolapse No	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Previous surgery for pelvic organ prolapse Yes	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Prior Hysterectomy No	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Prior Hysterectomy Yes	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Weeks

Population: The analysis for the primary outcome includes all randomized subjects.

Outcome measures

Outcome measures
Measure	Laparoscopic Abdominal Sacrocolpopexy (LASC) n=38 Participants Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)	Robotic Assisted Laparoscopic (RASC) n=40 Participants Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy	11573 Dollars Standard Deviation 3191	19616 Dollars Standard Deviation 3135

SECONDARY outcome

Timeframe: 6 Months

Population: The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention.

At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.

Outcome measures

Outcome measures
Measure	Laparoscopic Abdominal Sacrocolpopexy (LASC) n=35 Participants Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)	Robotic Assisted Laparoscopic (RASC) n=38 Participants Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy	25.1 units on a scale Standard Deviation 31.4	31.3 units on a scale Standard Deviation 35.3

Adverse Events

Laparoscopic Abdominal Sacrocolpopexy (LASC)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Robotic Assisted Laparoscopic (RASC)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Laparoscopic Abdominal Sacrocolpopexy (LASC) n=38 participants at risk Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)	Robotic Assisted Laparoscopic (RASC) n=40 participants at risk Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Surgical and medical procedures Mesh Exposure	0.00% 0/38 • Adverse event data were collected for 1 year, 9 months	7.5% 3/40 • Number of events 3 • Adverse event data were collected for 1 year, 9 months
Surgical and medical procedures Illiac Vein Injury	2.6% 1/38 • Number of events 1 • Adverse event data were collected for 1 year, 9 months	2.5% 1/40 • Number of events 1 • Adverse event data were collected for 1 year, 9 months
Gastrointestinal disorders Diverticulitis	0.00% 0/38 • Adverse event data were collected for 1 year, 9 months	2.5% 1/40 • Number of events 1 • Adverse event data were collected for 1 year, 9 months
Gastrointestinal disorders Incarcerated Hernia	2.6% 1/38 • Number of events 1 • Adverse event data were collected for 1 year, 9 months	2.5% 1/40 • Number of events 1 • Adverse event data were collected for 1 year, 9 months
Reproductive system and breast disorders Tissue granulation	7.9% 3/38 • Number of events 4 • Adverse event data were collected for 1 year, 9 months	0.00% 0/40 • Adverse event data were collected for 1 year, 9 months
Cardiac disorders Atrial fibrillation	2.6% 1/38 • Number of events 1 • Adverse event data were collected for 1 year, 9 months	0.00% 0/40 • Adverse event data were collected for 1 year, 9 months
Gastrointestinal disorders Mallory-Weiss tear	2.6% 1/38 • Number of events 1 • Adverse event data were collected for 1 year, 9 months	0.00% 0/40 • Adverse event data were collected for 1 year, 9 months
General disorders Dyspnea	0.00% 0/38 • Adverse event data were collected for 1 year, 9 months	2.5% 1/40 • Number of events 1 • Adverse event data were collected for 1 year, 9 months
Surgical and medical procedures Intraoperative cystotomy	2.6% 1/38 • Number of events 1 • Adverse event data were collected for 1 year, 9 months	2.5% 1/40 • Number of events 1 • Adverse event data were collected for 1 year, 9 months
Gastrointestinal disorders Bowel obstruction	2.6% 1/38 • Number of events 1 • Adverse event data were collected for 1 year, 9 months	0.00% 0/40 • Adverse event data were collected for 1 year, 9 months

Additional Information

Elizabeth Mueller, M.D.

Loyola University

Phone: 708-216-2180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place