Hemorrhoids
Conditions
Keywords
hemorrhoid, hemorrhoid stapler
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.
Interventions
DEVICEEEA Hemorrhoid and Prolapse Stapling Set
Surgical device
DEVICEEndosurgery Proximate PPH03 Stapling Set
Surgical device
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
| Operative Room (OR) Time | Day 0 | Time of insertion of anoscope to time of anoscope removal after stapleline evaluation |
| Location of the Staple Line | Day 0 | Distance of staple line to dentate line as measure by surgical ruler |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set EEA Hemorrhoid and Prolapse Stapling Set: Surgical device | 78 |
| Endosurgery Proximate PPH03 Stapling Set Endosurgery Proximate PPH03 Stapling Set: Surgical device | 71 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | EEA Hemorrhoid and Prolapse Stapling Set | Total | Endosurgery Proximate PPH03 Stapling Set |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 13.8 | 53.8 years STANDARD_DEVIATION 13.7 | 52.1 years STANDARD_DEVIATION 13.4 |
| BMI | 27.94 kg/m2 STANDARD_DEVIATION 17.61 | 27.54 kg/m2 STANDARD_DEVIATION 4.97 | 27.11 kg/m2 STANDARD_DEVIATION 4.85 |
| Hemorrhoid Grade Grade 1 | 0 participants | 0 participants | 0 participants |
| Hemorrhoid Grade Grade 2 | 28 participants | 48 participants | 20 participants |
| Hemorrhoid Grade Grade 3 | 50 participants | 101 participants | 51 participants |
| Hemorrhoid Grade Grade 4 | 0 participants | 0 participants | 0 participants |
| Prior Hemorrhoid Treatment At least 1 Treatment | 29 participants | 65 participants | 36 participants |
| Prior Hemorrhoid Treatment No Treatment | 49 participants | 84 participants | 35 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 66 Participants | 124 Participants | 58 Participants |
| Sex: Female, Male Female | 39 Participants | 66 Participants | 27 Participants |
| Sex: Female, Male Male | 39 Participants | 83 Participants | 44 Participants |
| Smoking History Current Smoker | 17 participants | 26 participants | 9 participants |
| Smoking History Non-Smoker | 49 participants | 87 participants | 38 participants |
| Smoking History Past Smoker | 12 participants | 36 participants | 24 participants |
| Weight | 81.69 Kg STANDARD_DEVIATION 17.61 | 81.50 Kg STANDARD_DEVIATION 18.05 | 81.29 Kg STANDARD_DEVIATION 18.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 65 / 81 | 40 / 68 |
| serious Total, serious adverse events | 2 / 81 | 3 / 68 |
Outcome results
Primary
Intraoperative Bleeding
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Intraoperative Bleeding | 32 participants |
| Endosurgery Proximate PPH03 Stapling Set | Intraoperative Bleeding | 50 participants |
p-value: 0.0001Chi-squared
Secondary
Length of Stay
Length of hospital stay is defined as time of anoscope insertion until discharge
Time frame: Day 0 time of discharge minus time of admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Length of Stay | 4.16 Hours | Standard Deviation 6.17 |
| Endosurgery Proximate PPH03 Stapling Set | Length of Stay | 4.37 Hours | Standard Deviation 6.64 |
p-value: 0.5647Wilcoxon (Mann-Whitney)
Secondary
Location of the Staple Line
Distance of staple line to dentate line as measure by surgical ruler
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Location of the Staple Line | 25.94 mm | Standard Deviation 8.23 |
| Endosurgery Proximate PPH03 Stapling Set | Location of the Staple Line | 24.00 mm | Standard Deviation 8.39 |
p-value: 0.1844Wilcoxon (Mann-Whitney)
Secondary
Operative Room (OR) Time
Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Operative Room (OR) Time | 25.4 minutes | Standard Deviation 14.5 |
| Endosurgery Proximate PPH03 Stapling Set | Operative Room (OR) Time | 25.6 minutes | Standard Deviation 13.2 |
p-value: 0.9062Wilcoxon (Mann-Whitney)
Secondary
Overall Quality of Life - General Health Score
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Overall Quality of Life - General Health Score | 1 week | -0.26 units on a scale | Standard Deviation 6.27 |
| EEA Hemorrhoid and Prolapse Stapling Set | Overall Quality of Life - General Health Score | 3 month | 0.88 units on a scale | Standard Deviation 8.46 |
| EEA Hemorrhoid and Prolapse Stapling Set | Overall Quality of Life - General Health Score | 1 month | 0.44 units on a scale | Standard Deviation 8.06 |
| EEA Hemorrhoid and Prolapse Stapling Set | Overall Quality of Life - General Health Score | 6 month | 1.36 units on a scale | Standard Deviation 7.93 |
| EEA Hemorrhoid and Prolapse Stapling Set | Overall Quality of Life - General Health Score | baseline | 53.89 units on a scale | Standard Deviation 8.31 |
| Endosurgery Proximate PPH03 Stapling Set | Overall Quality of Life - General Health Score | 6 month | -0.72 units on a scale | Standard Deviation 6.46 |
| Endosurgery Proximate PPH03 Stapling Set | Overall Quality of Life - General Health Score | baseline | 54.58 units on a scale | Standard Deviation 8.65 |
| Endosurgery Proximate PPH03 Stapling Set | Overall Quality of Life - General Health Score | 1 week | -2.13 units on a scale | Standard Deviation 5.9 |
| Endosurgery Proximate PPH03 Stapling Set | Overall Quality of Life - General Health Score | 1 month | -1.05 units on a scale | Standard Deviation 6.62 |
| Endosurgery Proximate PPH03 Stapling Set | Overall Quality of Life - General Health Score | 3 month | -0.05 units on a scale | Standard Deviation 6.91 |
Secondary
Post-Operative Pain (Analgesic Intake)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Post-Operative Pain (Analgesic Intake) | 1 month - 3 month post op | 2 participants |
| EEA Hemorrhoid and Prolapse Stapling Set | Post-Operative Pain (Analgesic Intake) | 3 month - 6 month post op | 2 participants |
| EEA Hemorrhoid and Prolapse Stapling Set | Post-Operative Pain (Analgesic Intake) | Surgery - discharge | 37 participants |
| EEA Hemorrhoid and Prolapse Stapling Set | Post-Operative Pain (Analgesic Intake) | Discharge - 1 week post op | 29 participants |
| EEA Hemorrhoid and Prolapse Stapling Set | Post-Operative Pain (Analgesic Intake) | 1 week - 2 week post op | 14 participants |
| EEA Hemorrhoid and Prolapse Stapling Set | Post-Operative Pain (Analgesic Intake) | 2 week - 1 month post op | 5 participants |
| Endosurgery Proximate PPH03 Stapling Set | Post-Operative Pain (Analgesic Intake) | 1 week - 2 week post op | 15 participants |
| Endosurgery Proximate PPH03 Stapling Set | Post-Operative Pain (Analgesic Intake) | 1 month - 3 month post op | 2 participants |
| Endosurgery Proximate PPH03 Stapling Set | Post-Operative Pain (Analgesic Intake) | Discharge - 1 week post op | 18 participants |
| Endosurgery Proximate PPH03 Stapling Set | Post-Operative Pain (Analgesic Intake) | 3 month - 6 month post op | 2 participants |
| Endosurgery Proximate PPH03 Stapling Set | Post-Operative Pain (Analgesic Intake) | 2 week - 1 month post op | 2 participants |
| Endosurgery Proximate PPH03 Stapling Set | Post-Operative Pain (Analgesic Intake) | Surgery - discharge | 25 participants |
Secondary
Post Operative Pain - (PI-NIRS)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 minus 60) Baseline | 2.0 units on a scale | Standard Deviation 2.3 |
| EEA Hemorrhoid and Prolapse Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0) Discharge | 1.0 units on a scale | Standard Deviation 2.8 |
| EEA Hemorrhoid and Prolapse Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 7) Week 1 | 0.5 units on a scale | Standard Deviation 3.1 |
| EEA Hemorrhoid and Prolapse Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 30) Month 1 | -1.0 units on a scale | Standard Deviation 2.5 |
| EEA Hemorrhoid and Prolapse Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 90) Month 3 | -1.5 units on a scale | Standard Deviation 2.2 |
| EEA Hemorrhoid and Prolapse Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 180) Month 6 | -1.5 units on a scale | Standard Deviation 2.3 |
| Endosurgery Proximate PPH03 Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 90) Month 3 | -1.8 units on a scale | Standard Deviation 2.8 |
| Endosurgery Proximate PPH03 Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 minus 60) Baseline | 2.1 units on a scale | Standard Deviation 2.6 |
| Endosurgery Proximate PPH03 Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 30) Month 1 | -1.4 units on a scale | Standard Deviation 2.8 |
| Endosurgery Proximate PPH03 Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0) Discharge | 0.8 units on a scale | Standard Deviation 3.1 |
| Endosurgery Proximate PPH03 Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 180) Month 6 | -2.0 units on a scale | Standard Deviation 2.6 |
| Endosurgery Proximate PPH03 Stapling Set | Post Operative Pain - (PI-NIRS) | (Day 0 plus 7) Week 1 | 0.3 units on a scale | Standard Deviation 3.2 |