N/A
N=149
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
Hemorrhoids
Bottom Line
View on ClinicalTrials.gov: NCT01306877 ↗Enrolled (actual)
149
Serious AEs
3.4%
Results posted
Oct 2014
Primary outcome: Primary: Intraoperative Bleeding — 32; 50 participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EEA Hemorrhoid and Prolapse Stapling Set (Device); Endosurgery Proximate PPH03 Stapling Set (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Bleeding |
32; 50 | 0.0001 sig |
| SECONDARY Post Operative Pain - (PI-NIRS) |
2.0; 2.1; 1.0; 0.8; 0.5; 0.3 | — |
| SECONDARY Post-Operative Pain (Analgesic Intake) |
37; 25; 29; 18; 14; 15 | — |
| SECONDARY Overall Quality of Life - General Health Score |
53.89; 54.58; -0.26; -2.13; 0.44; -1.05 | — |
| SECONDARY Location of the Staple Line |
25.94; 24.00 | 0.1844 |
| SECONDARY Length of Stay |
4.16; 4.37 | 0.5647 |
| SECONDARY Operative Room (OR) Time |
25.4; 25.6 | 0.9062 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01306877). 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.