HEMOSTASIS: Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01306877
• Collaborator: (none)
• Enrollment: 149
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids	Device: EEA Hemorrhoid and Prolapse Stapling Set; Device: Endosurgery Proximate PPH03 Stapling Set	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EEA Hemorrhoid and Prolapse Stapling Set	Device: EEA Hemorrhoid and Prolapse Stapling Set; Surgical device
Active Comparator: Endosurgery Proximate PPH03 Stapling Set	Device: Endosurgery Proximate PPH03 Stapling Set; Surgical device

Outcome Measures

Primary Outcome Measures

1. Intraoperative Bleeding [Day 0 - time of surgery]

   Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.

Secondary Outcome Measures

1. Post Operative Pain - (PI-NIRS) [Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180]

   Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain. The data represented is the change in baseline score at the different timepoints.

2. Post-Operative Pain (Analgesic Intake) [Day 0, 1 week, 2 week, 1 month, 3 month, 6 month]

   post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.

3. Overall Quality of Life - General Health Score [Day 0 minus 60, 1 week, 1 month, 3 months, 6 months]

   Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health

4. Location of the Staple Line [Day 0]

   Distance of staple line to dentate line as measure by surgical ruler

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

   Length of hospital stay is defined as time of anoscope insertion until discharge

6. Operative Room (OR) Time [Day 0]

   Time of insertion of anoscope to time of anoscope removal after stapleline evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject is able to understand and sign Informed Consent Form

• The subject is between 18-85 years of age.

• The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy

Exclusion Criteria:

• The procedure is needed as revision hemorrhoid surgery.

• Any female patient, who is pregnant, suspected pregnant, or nursing.

• 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 1 year 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 has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.

• The participant has a history of fecal incontinence

• The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening

• 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	USF Tampa General Hospital Dept of Surgery	Tampa	Florida	United States	33606

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Jorge Marcet, MD, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01306877
• Other Study ID Numbers: COVHEPH0109
• First Posted: Mar 2, 2011
• Last Update Posted: Oct 29, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Medtronic - MITG: hemorrhoid; hemorrhoid stapler
• Additional relevant MeSH terms: Hemorrhoids

Study Results

Participant Flow

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set : Surgical device	Endosurgery Proximate PPH03 Stapling Set : Surgical device
Period Title: Overall Study
STARTED	78	71
COMPLETED	75	67
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set	Total
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device	Total of all reporting groups
Overall Participants	78	71	149
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (13.8)	52.1 (13.4)	53.8 (13.7)
Sex: Female, Male (Count of Participants)
Female	39 50%	27 38%	66 44.3%
Male	39 50%	44 62%	83 55.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 3.8%	2 2.8%	5 3.4%
Native Hawaiian or Other Pacific Islander	1 1.3%	0 0%	1 0.7%
Black or African American	5 6.4%	7 9.9%	12 8.1%
White	66 84.6%	58 81.7%	124 83.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 3.8%	4 5.6%	7 4.7%
Hemorrhoid Grade (participants) [Number]
Grade 1	0 0%	0 0%	0 0%
Grade 2	28 35.9%	20 28.2%	48 32.2%
Grade 3	50 64.1%	51 71.8%	101 67.8%
Grade 4	0 0%	0 0%	0 0%
Smoking History (participants) [Number]
Non-Smoker	49 62.8%	38 53.5%	87 58.4%
Past Smoker	12 15.4%	24 33.8%	36 24.2%
Current Smoker	17 21.8%	9 12.7%	26 17.4%
Prior Hemorrhoid Treatment (participants) [Number]
At least 1 Treatment	29 37.2%	36 50.7%	65 43.6%
No Treatment	49 62.8%	35 49.3%	84 56.4%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.94 (17.61)	27.11 (4.85)	27.54 (4.97)
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	81.69 (17.61)	81.29 (18.65)	81.50 (18.05)

Outcome Measures

1. Primary Outcome

Title	Intraoperative Bleeding
Description	Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.
Time Frame	Day 0 - time of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	76	68
Number [participants]	32 41%	50 70.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe's generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is <7%.
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P-value calculated from per protocol analysis set
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.314
	Confidence Interval	(1-Sided) 95%; to -0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Post Operative Pain - (PI-NIRS)
Description	Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain. The data represented is the change in baseline score at the different timepoints.
Time Frame	Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	78	71
(Day 0 minus 60) Baseline	2.0 (2.3)	2.1 (2.6)
(Day 0) Discharge	1.0 (2.8)	0.8 (3.1)
(Day 0 plus 7) Week 1	0.5 (3.1)	0.3 (3.2)
(Day 0 plus 30) Month 1	-1.0 (2.5)	-1.4 (2.8)
(Day 0 plus 90) Month 3	-1.5 (2.2)	-1.8 (2.8)
(Day 0 plus 180) Month 6	-1.5 (2.3)	-2.0 (2.6)

3. Secondary Outcome

Title	Post-Operative Pain (Analgesic Intake)
Description	post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.
Time Frame	Day 0, 1 week, 2 week, 1 month, 3 month, 6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	78	71
Surgery - discharge	37 47.4%	25 35.2%
Discharge - 1 week post op	29 37.2%	18 25.4%
1 week - 2 week post op	14 17.9%	15 21.1%
2 week - 1 month post op	5 6.4%	2 2.8%
1 month - 3 month post op	2 2.6%	2 2.8%
3 month - 6 month post op	2 2.6%	2 2.8%

4. Secondary Outcome

Title	Overall Quality of Life - General Health Score
Description	Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health
Time Frame	Day 0 minus 60, 1 week, 1 month, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	70	62
baseline	53.89 (8.31)	54.58 (8.65)
1 week	-0.26 (6.27)	-2.13 (5.90)
1 month	0.44 (8.06)	-1.05 (6.62)
3 month	0.88 (8.46)	-0.05 (6.91)
6 month	1.36 (7.93)	-0.72 (6.46)

5. Secondary Outcome

Title	Location of the Staple Line
Description	Distance of staple line to dentate line as measure by surgical ruler
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	78	71
Mean (Standard Deviation) [mm]	25.94 (8.23)	24.00 (8.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1844
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Length of Stay
Description	Length of hospital stay is defined as time of anoscope insertion until discharge
Time Frame	Day 0 time of discharge minus time of admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	78	71
Mean (Standard Deviation) [Hours]	4.16 (6.17)	4.37 (6.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5647
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Operative Room (OR) Time
Description	Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set	Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set: Surgical device
Measure Participants	78	71
Mean (Standard Deviation) [minutes]	25.4 (14.5)	25.6 (13.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9062
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Two years - January 2011 to Jan 2013
Adverse Event Reporting Description	HEEA N=81 is the total population that was intended to be randomized to the study device using the intent to treat modality. The per protocol population once the misrandomized subjects were excluded is N=78
Arm/Group Title	EEA Hemorrhoid and Prolapse Stapling Set		Endosurgery Proximate PPH03 Stapling Set
Arm/Group Description	EEA Hemorrhoid and Prolapse Stapling Set: Surgical device		Endosurgery Proximate PPH03 Stapling Set: Surgical device
All Cause Mortality
	EEA Hemorrhoid and Prolapse Stapling Set		Endosurgery Proximate PPH03 Stapling Set
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EEA Hemorrhoid and Prolapse Stapling Set		Endosurgery Proximate PPH03 Stapling Set
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/81 (2.5%)		3/68 (4.4%)
Gastrointestinal disorders
Faecoloma	1/81 (1.2%)	1	0/68 (0%)	0
Proctalgia	0/81 (0%)	0	1/68 (1.5%)	1
Infections and infestations
Tooth Abscess	0/81 (0%)	0	1/68 (1.5%)	1
Injury, poisoning and procedural complications
Procedural Pain	0/81 (0%)	0	1/68 (1.5%)	1
Renal and urinary disorders
Urinary Retention	1/81 (1.2%)	1	0/68 (0%)	0
Other (Not Including Serious) Adverse Events
	EEA Hemorrhoid and Prolapse Stapling Set		Endosurgery Proximate PPH03 Stapling Set
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	65/81 (80.2%)		40/68 (58.8%)
Gastrointestinal disorders
Anorectal Discomfort	7/81 (8.6%)	8	0/68 (0%)	0
Constipation	5/81 (6.2%)	5	0/68 (0%)	0
Haematochezia	5/81 (6.2%)	5	0/68 (0%)	0
Nausea	0/81 (0%)	0	4/68 (5.9%)	4
Proctalgia	19/81 (23.5%)	21	13/68 (19.1%)	13
Rectal Hemorrhage	14/81 (17.3%)	17	19/68 (27.9%)	20
Injury, poisoning and procedural complications
Operative Hemorrhage	0/81 (0%)	0	7/68 (10.3%)	7
Surgical and medical procedures
Suture Insertion	15/81 (18.5%)	15	17/68 (25%)	17
Vascular disorders
Hemorrhage	0/81 (0%)	0	8/68 (11.8%)	9

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.