Trial Outcomes & Findings for Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure (NCT NCT01169311)

NCT ID: NCT01169311

Last Updated: 2014-10-06

Results Overview

Successful creation of staple line at first firing of device during hemorrhoidopexy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: about 20 minutes for procedure
• Results posted on: 2014-10-06

Participant Flow

Between 21 July 2010 and 17 March 2011 patients were recruited at 2 medical clinic and one hospital; subjects with grades 2-4 hemorrhoids eligible for stapled hemorroidopexy were assessed for eligibility for study; exclusion criteria: pregnant,Ab use for SSI, drug/alcohol abuse, aspirin/anticuagulant therapy, hx VT, hx PE,

Participant milestones

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

Baseline characteristics by cohort

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants Subjects undergoing hemorrhoidopexy with HEEA stapler
Age, Continuous	49.2 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: about 20 minutes for procedure

Successful creation of staple line at first firing of device during hemorrhoidopexy

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Uneventful Creation of a Functional Staple Line at First Firing of Device	27 participants

SECONDARY outcome

Timeframe: Day 0 - Time of stop minus time of start

Duration of procedure

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
OR Time	21.5 minutes Standard Deviation 7.8

SECONDARY outcome

Timeframe: Day 0 - time of surgery

Incidence of intervention for intra-operative staple-line bleeding

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Intra-Operative Bleeding Requiring Intervention	12 participants

SECONDARY outcome

Timeframe: Day 0, time of discharge minus time of admission

length of time between time of admission and time of discharge

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Length of Stay	146.6 Minutes Standard Deviation 167.5

SECONDARY outcome

Timeframe: 30 days post op

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Time to Return to Normal Activity	11.1 Days Standard Deviation 5.5

SECONDARY outcome

Timeframe: about 20 minutes for procedure

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Incidence of Stapler Malfunction or Misfires	0 participants

SECONDARY outcome

Timeframe: baseline, 30 days post op

Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Post Operative Pain	-1.0 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: baseline, 30 days post op

Population: Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.

Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=24 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Quality of Life, Physical Component Baseline	52.95 units on a scale Standard Deviation 8.00
Quality of Life, Physical Component 30 days post op	-1.61 units on a scale Standard Deviation 8.33

SECONDARY outcome

Timeframe: Baseline, 30 days post op

Population: Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.

quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation

Outcome measures

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=24 Participants subjects will have have hemorrhoidopexy using the EEA stapler
Quality of Life, Mental Component Baseline	56.12 units on a scale Standard Deviation 5.47
Quality of Life, Mental Component 30 Days post op	-0.07 units on a scale Standard Deviation 3.74

Adverse Events

Covidien EEA Hemorrhoid and Prolapse Stapler

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Covidien EEA Hemorrhoid and Prolapse Stapler n=27 participants at risk Subjects undergoing hemorrhoidopexy with HEEA stapler
Gastrointestinal disorders Anorectal Discomfort	37.0% 10/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
Gastrointestinal disorders Constipation	7.4% 2/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
Gastrointestinal disorders Nausea	7.4% 2/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
Gastrointestinal disorders proctalgia	33.3% 9/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
Gastrointestinal disorders Rectal Hemorrhage	40.7% 11/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
Gastrointestinal disorders vomitting	7.4% 2/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
General disorders Local Swelling	7.4% 2/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
Injury, poisoning and procedural complications Post procedural hemorrhage	11.1% 3/27 • Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.

Additional Information

Tam LaFleur

Covidien

Phone: 203-821-4744

Email: tam.lafleur@covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place