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

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01169311
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Trial Objectives

The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:

overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoid	Device: Hemorrhoidopexy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HEEA Stapler hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set	Device: Hemorrhoidopexy; Other Names: Covidien EEA Hemorrhoid and Prolapse Stapling set

Outcome Measures

Primary Outcome Measures

1. Uneventful Creation of a Functional Staple Line at First Firing of Device [about 20 minutes for procedure]

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

Secondary Outcome Measures

1. OR Time [Day 0 - Time of stop minus time of start]

   Duration of procedure

2. Intra-Operative Bleeding Requiring Intervention [Day 0 - time of surgery]

   Incidence of intervention for intra-operative staple-line bleeding

3. Length of Stay [Day 0, time of discharge minus time of admission]

   length of time between time of admission and time of discharge

4. Time to Return to Normal Activity [30 days post op]

5. Incidence of Stapler Malfunction or Misfires [about 20 minutes for procedure]

6. Post Operative Pain [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

7. Quality of Life, Physical Component [baseline, 30 days post op]

   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

8. Quality of Life, Mental Component [Baseline, 30 days post op]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to understand and sign Informed Consent Form

• The participant must be 18-80 years of age.

• The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

Exclusion Criteria:

• The procedure is needed as revision hemorrhoid surgery.

• The participant is pregnant.

• The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.

• The participant is unable or unwilling to comply with the study requirements, follow-up schedule.

• The participant has a history of drug or alcohol abuse.

• The participant has a history of venous thrombosis or pulmonary embolism.

• The participant has a history of coagulopathy.

• The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date

• The participant has a history of fecal incontinence.

• The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Sang Lee, M.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01169311
• Other Study ID Numbers: COVHEPH0021
• First Posted: Jul 26, 2010
• Last Update Posted: Oct 6, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Medtronic - MITG: Hemorrhoids; Hemorrhoid; grade II, III, IV
• Additional relevant MeSH terms: Hemorrhoids; Prolapse

Study Results

Participant Flow

Recruitment Details	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,

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

Baseline Characteristics

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	Subjects undergoing hemorrhoidopexy with HEEA stapler
Overall Participants	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.2 (12.8)
Sex: Female, Male (Count of Participants)
Female	9 33.3%
Male	18 66.7%
Region of Enrollment (participants) [Number]
United States	27 100%

Outcome Measures

1. Primary Outcome

Title	Uneventful Creation of a Functional Staple Line at First Firing of Device
Description	Successful creation of staple line at first firing of device during hemorrhoidopexy
Time Frame	about 20 minutes for procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	27
Number [participants]	27 100%

2. Secondary Outcome

Title	OR Time
Description	Duration of procedure
Time Frame	Day 0 - Time of stop minus time of start

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	27
Mean (Standard Deviation) [minutes]	21.5 (7.8)

3. Secondary Outcome

Title	Intra-Operative Bleeding Requiring Intervention
Description	Incidence of intervention for intra-operative staple-line bleeding
Time Frame	Day 0 - time of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	27
Number [participants]	12 44.4%

4. Secondary Outcome

Title	Length of Stay
Description	length of time between time of admission and time of discharge
Time Frame	Day 0, time of discharge minus time of admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	27
Mean (Standard Deviation) [Minutes]	146.6 (167.5)

5. Secondary Outcome

Title	Time to Return to Normal Activity
Time Frame	30 days post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	27
Mean (Standard Deviation) [Days]	11.1 (5.5)

6. Secondary Outcome

Title	Incidence of Stapler Malfunction or Misfires
Time Frame	about 20 minutes for procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
Measure Participants	27
Number [participants]	0 0%

7. Secondary Outcome

Title	Post Operative Pain
Description	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
Time Frame	baseline, 30 days post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	27
Mean (Standard Deviation) [units on a scale]	-1.0 (1.5)

8. Secondary Outcome

Title	Quality of Life, Physical Component
Description	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
Time Frame	baseline, 30 days post op

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	24
Baseline	52.95 (8.00)
30 days post op	-1.61 (8.33)

9. Secondary Outcome

Title	Quality of Life, Mental Component
Description	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
Time Frame	Baseline, 30 days post op

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	subjects will have have hemorrhoidopexy using the EEA stapler
Measure Participants	24
Baseline	56.12 (5.47)
30 Days post op	-0.07 (3.74)

Adverse Events

Time Frame	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.
Arm/Group Title	Covidien EEA Hemorrhoid and Prolapse Stapler
Arm/Group Description	Subjects undergoing hemorrhoidopexy with HEEA stapler
All Cause Mortality
	Covidien EEA Hemorrhoid and Prolapse Stapler
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Covidien EEA Hemorrhoid and Prolapse Stapler
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Other (Not Including Serious) Adverse Events
	Covidien EEA Hemorrhoid and Prolapse Stapler
	Affected / at Risk (%)	# Events
Total	15/27 (55.6%)
Gastrointestinal disorders
Anorectal Discomfort	10/27 (37%)
Constipation	2/27 (7.4%)
Nausea	2/27 (7.4%)
proctalgia	9/27 (33.3%)
Rectal Hemorrhage	11/27 (40.7%)
vomitting	2/27 (7.4%)
General disorders
Local Swelling	2/27 (7.4%)
Injury, poisoning and procedural complications
Post procedural hemorrhage	3/27 (11.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.