Trial Outcomes & Findings for Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids (NCT NCT01306877)

Last Updated: 2014-10-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

149 participants

Primary outcome timeframe

Day 0 - time of surgery

Results posted on

2014-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	EEA Hemorrhoid and Prolapse Stapling Set EEA Hemorrhoid and Prolapse Stapling Set : Surgical device	Endosurgery Proximate PPH03 Stapling Set Endosurgery Proximate PPH03 Stapling Set : Surgical device
Overall Study STARTED	78	71
Overall Study COMPLETED	75	67
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	EEA Hemorrhoid and Prolapse Stapling Set EEA Hemorrhoid and Prolapse Stapling Set : Surgical device	Endosurgery Proximate PPH03 Stapling Set Endosurgery Proximate PPH03 Stapling Set : Surgical device
Overall Study Lost to Follow-up	3	3
Overall Study Physician Decision	0	1

Baseline Characteristics

Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=78 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=71 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device	Total n=149 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 13.8 • n=5 Participants	52.1 years STANDARD_DEVIATION 13.4 • n=7 Participants	53.8 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	27 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	44 Participants n=7 Participants	83 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	58 Participants n=7 Participants	124 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	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Hemorrhoid Grade Grade 1	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Hemorrhoid Grade Grade 2	28 participants n=5 Participants	20 participants n=7 Participants	48 participants n=5 Participants
Hemorrhoid Grade Grade 3	50 participants n=5 Participants	51 participants n=7 Participants	101 participants n=5 Participants
Hemorrhoid Grade Grade 4	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Smoking History Non-Smoker	49 participants n=5 Participants	38 participants n=7 Participants	87 participants n=5 Participants
Smoking History Past Smoker	12 participants n=5 Participants	24 participants n=7 Participants	36 participants n=5 Participants
Smoking History Current Smoker	17 participants n=5 Participants	9 participants n=7 Participants	26 participants n=5 Participants
Prior Hemorrhoid Treatment At least 1 Treatment	29 participants n=5 Participants	36 participants n=7 Participants	65 participants n=5 Participants
Prior Hemorrhoid Treatment No Treatment	49 participants n=5 Participants	35 participants n=7 Participants	84 participants n=5 Participants
BMI	27.94 kg/m2 STANDARD_DEVIATION 17.61 • n=5 Participants	27.11 kg/m2 STANDARD_DEVIATION 4.85 • n=7 Participants	27.54 kg/m2 STANDARD_DEVIATION 4.97 • n=5 Participants
Weight	81.69 Kg STANDARD_DEVIATION 17.61 • n=5 Participants	81.29 Kg STANDARD_DEVIATION 18.65 • n=7 Participants	81.50 Kg STANDARD_DEVIATION 18.05 • n=5 Participants

PRIMARY outcome

Timeframe: Day 0 - time of surgery

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=76 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=68 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Intraoperative Bleeding	32 participants	50 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=78 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=71 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Post Operative Pain - (PI-NIRS) (Day 0 minus 60) Baseline	2.0 units on a scale Standard Deviation 2.3	2.1 units on a scale Standard Deviation 2.6
Post Operative Pain - (PI-NIRS) (Day 0) Discharge	1.0 units on a scale Standard Deviation 2.8	0.8 units on a scale Standard Deviation 3.1
Post Operative Pain - (PI-NIRS) (Day 0 plus 7) Week 1	0.5 units on a scale Standard Deviation 3.1	0.3 units on a scale Standard Deviation 3.2
Post Operative Pain - (PI-NIRS) (Day 0 plus 30) Month 1	-1.0 units on a scale Standard Deviation 2.5	-1.4 units on a scale Standard Deviation 2.8
Post Operative Pain - (PI-NIRS) (Day 0 plus 90) Month 3	-1.5 units on a scale Standard Deviation 2.2	-1.8 units on a scale Standard Deviation 2.8
Post Operative Pain - (PI-NIRS) (Day 0 plus 180) Month 6	-1.5 units on a scale Standard Deviation 2.3	-2.0 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=78 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=71 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Post-Operative Pain (Analgesic Intake) Surgery - discharge	37 participants	25 participants
Post-Operative Pain (Analgesic Intake) Discharge - 1 week post op	29 participants	18 participants
Post-Operative Pain (Analgesic Intake) 1 week - 2 week post op	14 participants	15 participants
Post-Operative Pain (Analgesic Intake) 2 week - 1 month post op	5 participants	2 participants
Post-Operative Pain (Analgesic Intake) 1 month - 3 month post op	2 participants	2 participants
Post-Operative Pain (Analgesic Intake) 3 month - 6 month post op	2 participants	2 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=70 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=62 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Overall Quality of Life - General Health Score baseline	53.89 units on a scale Standard Deviation 8.31	54.58 units on a scale Standard Deviation 8.65
Overall Quality of Life - General Health Score 1 week	-0.26 units on a scale Standard Deviation 6.27	-2.13 units on a scale Standard Deviation 5.90
Overall Quality of Life - General Health Score 1 month	0.44 units on a scale Standard Deviation 8.06	-1.05 units on a scale Standard Deviation 6.62
Overall Quality of Life - General Health Score 3 month	0.88 units on a scale Standard Deviation 8.46	-0.05 units on a scale Standard Deviation 6.91
Overall Quality of Life - General Health Score 6 month	1.36 units on a scale Standard Deviation 7.93	-0.72 units on a scale Standard Deviation 6.46

SECONDARY outcome

Timeframe: Day 0

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

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=78 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=71 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Location of the Staple Line	25.94 mm Standard Deviation 8.23	24.00 mm Standard Deviation 8.39

SECONDARY outcome

Timeframe: Day 0 time of discharge minus time of admission

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

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=78 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=71 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Length of Stay	4.16 Hours Standard Deviation 6.17	4.37 Hours Standard Deviation 6.64

SECONDARY outcome

Timeframe: Day 0

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

Outcome measures

Outcome measures
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=78 Participants EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=71 Participants Endosurgery Proximate PPH03 Stapling Set: Surgical device
Operative Room (OR) Time	25.4 minutes Standard Deviation 14.5	25.6 minutes Standard Deviation 13.2

Adverse Events

EEA Hemorrhoid and Prolapse Stapling Set

Serious events: 2 serious events

Other events: 65 other events

Deaths: 0 deaths

Endosurgery Proximate PPH03 Stapling Set

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=81 participants at risk EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=68 participants at risk Endosurgery Proximate PPH03 Stapling Set: Surgical device
Gastrointestinal disorders Faecoloma	1.2% 1/81 • Number of events 1 • Two years - January 2011 to Jan 2013 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	0.00% 0/68 • Two years - January 2011 to Jan 2013 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
Gastrointestinal disorders Proctalgia	0.00% 0/81 • Two years - January 2011 to Jan 2013 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	1.5% 1/68 • Number of events 1 • Two years - January 2011 to Jan 2013 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
Infections and infestations Tooth Abscess	0.00% 0/81 • Two years - January 2011 to Jan 2013 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	1.5% 1/68 • Number of events 1 • Two years - January 2011 to Jan 2013 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
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/81 • Two years - January 2011 to Jan 2013 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	1.5% 1/68 • Number of events 1 • Two years - January 2011 to Jan 2013 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
Renal and urinary disorders Urinary Retention	1.2% 1/81 • Number of events 1 • Two years - January 2011 to Jan 2013 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	0.00% 0/68 • Two years - January 2011 to Jan 2013 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

Other adverse events

Other adverse events
Measure	EEA Hemorrhoid and Prolapse Stapling Set n=81 participants at risk EEA Hemorrhoid and Prolapse Stapling Set: Surgical device	Endosurgery Proximate PPH03 Stapling Set n=68 participants at risk Endosurgery Proximate PPH03 Stapling Set: Surgical device
Gastrointestinal disorders Anorectal Discomfort	8.6% 7/81 • Number of events 8 • Two years - January 2011 to Jan 2013 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	0.00% 0/68 • Two years - January 2011 to Jan 2013 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
Gastrointestinal disorders Constipation	6.2% 5/81 • Number of events 5 • Two years - January 2011 to Jan 2013 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	0.00% 0/68 • Two years - January 2011 to Jan 2013 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
Gastrointestinal disorders Haematochezia	6.2% 5/81 • Number of events 5 • Two years - January 2011 to Jan 2013 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	0.00% 0/68 • Two years - January 2011 to Jan 2013 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
Gastrointestinal disorders Nausea	0.00% 0/81 • Two years - January 2011 to Jan 2013 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	5.9% 4/68 • Number of events 4 • Two years - January 2011 to Jan 2013 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
Gastrointestinal disorders Proctalgia	23.5% 19/81 • Number of events 21 • Two years - January 2011 to Jan 2013 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	19.1% 13/68 • Number of events 13 • Two years - January 2011 to Jan 2013 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
Injury, poisoning and procedural complications Operative Hemorrhage	0.00% 0/81 • Two years - January 2011 to Jan 2013 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	10.3% 7/68 • Number of events 7 • Two years - January 2011 to Jan 2013 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
Surgical and medical procedures Suture Insertion	18.5% 15/81 • Number of events 15 • Two years - January 2011 to Jan 2013 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	25.0% 17/68 • Number of events 17 • Two years - January 2011 to Jan 2013 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
Vascular disorders Hemorrhage	0.00% 0/81 • Two years - January 2011 to Jan 2013 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	11.8% 8/68 • Number of events 9 • Two years - January 2011 to Jan 2013 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
Gastrointestinal disorders Rectal Hemorrhage	17.3% 14/81 • Number of events 17 • Two years - January 2011 to Jan 2013 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	27.9% 19/68 • Number of events 20 • Two years - January 2011 to Jan 2013 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

Additional Information

Tam LaFleur, Clinical Project Manager

Covidien

Phone: 203-821-4744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place