Hemorrhoid
Conditions
Keywords
Hemorrhoids, Hemorrhoid, grade II, III, IV
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.
Interventions
DEVICEHemorrhoidopexy
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intra-Operative Bleeding Requiring Intervention | Day 0 - time of surgery | Incidence of intervention for intra-operative staple-line bleeding |
| Length of Stay | Day 0, time of discharge minus time of admission | length of time between time of admission and time of discharge |
| Time to Return to Normal Activity | 30 days post op | — |
| OR Time | Day 0 - Time of stop minus time of start | Duration of procedure |
| 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 |
| 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 |
| 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 |
| Incidence of Stapler Malfunction or Misfires | about 20 minutes for procedure | — |
Countries
United States
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,
Participants by arm
| Arm | Count |
|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler Subjects undergoing hemorrhoidopexy with HEEA stapler | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Covidien EEA Hemorrhoid and Prolapse Stapler |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Uneventful Creation of a Functional Staple Line at First Firing of Device
Successful creation of staple line at first firing of device during hemorrhoidopexy
Time frame: about 20 minutes for procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Uneventful Creation of a Functional Staple Line at First Firing of Device | 27 participants |
Secondary
Incidence of Stapler Malfunction or Misfires
Time frame: about 20 minutes for procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Incidence of Stapler Malfunction or Misfires | 0 participants |
Secondary
Intra-Operative Bleeding Requiring Intervention
Incidence of intervention for intra-operative staple-line bleeding
Time frame: Day 0 - time of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Intra-Operative Bleeding Requiring Intervention | 12 participants |
Secondary
Length of Stay
length of time between time of admission and time of discharge
Time frame: Day 0, time of discharge minus time of admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Length of Stay | 146.6 Minutes | Standard Deviation 167.5 |
Secondary
OR Time
Duration of procedure
Time frame: Day 0 - Time of stop minus time of start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | OR Time | 21.5 minutes | Standard Deviation 7.8 |
Secondary
Post Operative Pain
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Post Operative Pain | -1.0 units on a scale | Standard Deviation 1.5 |
Secondary
Quality of Life, Mental Component
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Quality of Life, Mental Component | Baseline | 56.12 units on a scale | Standard Deviation 5.47 |
| Covidien EEA Hemorrhoid and Prolapse Stapler | Quality of Life, Mental Component | 30 Days post op | -0.07 units on a scale | Standard Deviation 3.74 |
Secondary
Quality of Life, Physical Component
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Quality of Life, Physical Component | Baseline | 52.95 units on a scale | Standard Deviation 8 |
| Covidien EEA Hemorrhoid and Prolapse Stapler | Quality of Life, Physical Component | 30 days post op | -1.61 units on a scale | Standard Deviation 8.33 |
Secondary
Time to Return to Normal Activity
Time frame: 30 days post op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Covidien EEA Hemorrhoid and Prolapse Stapler | Time to Return to Normal Activity | 11.1 Days | Standard Deviation 5.5 |