N/A
N=27
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Hemorrhoid
Bottom Line
View on ClinicalTrials.gov: NCT01169311 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Uneventful Creation of a Functional Staple Line at First Firing of Device — 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hemorrhoidopexy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uneventful Creation of a Functional Staple Line at First Firing of Device |
27 | — |
| SECONDARY OR Time |
21.5 | — |
| SECONDARY Intra-Operative Bleeding Requiring Intervention |
12 | — |
| SECONDARY Length of Stay |
146.6 | — |
| SECONDARY Time to Return to Normal Activity |
11.1 | — |
| SECONDARY Incidence of Stapler Malfunction or Misfires |
— | — |
| SECONDARY Post Operative Pain |
-1.0 | — |
| SECONDARY Quality of Life, Physical Component |
52.95; -1.61 | — |
| SECONDARY Quality of Life, Mental Component |
56.12; -0.07 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01169311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.