III Degree HemorrhoidsPhase 3EEA/PPH2011NCT01413867
Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
A Phase 3 study testing stapled hemorrhoidopexy in people with III Degree Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
Trial summary
Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- III Degree Hemorrhoids
- What is being tested?
- stapled hemorrhoidopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- III degree Hemorrhoids
- written informed consent
- mental ability to understand the procedure
Who cannot join
- Previous treatments for hemorrhoids or other proctological diseases
- Fecal Incontinence
- Chronic inflammatory bowel disease
- Anal sphincter lesions
- coagulative defects
- obstructed defecation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial
Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.
This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.
- Conditions
- III Degree Hemorrhoids
- Being tested
- stapled hemorrhoidopexy
- Keywords
- hemorrhoids, circular staplers, mucosal resection, hemostatic suture
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapled hemorrhoidopexyProcedure or surgery
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
stapled hemorrhoidopexyProcedure or surgery
stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery
| Study group | Role | What they receive |
|---|---|---|
| EEA group | Experimental | Group of patients with III degree hemorrhoids treated by EEA stapler Receives: Procedure: stapled hemorrhoidopexy |
| PPH group | Active comparator | group of patients with III degree hemorrhoids treated by PPH stapler Receives: Procedure: stapled hemorrhoidopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantity of anorectal mucosa resected using two different circular staplers
The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared
Measured: 1 hour following the end of the operation
Secondary outcomes (1)
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers
the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids
Measured: 1 hour after each operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for III Degree HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Donato F Altomare, Societa Italiana di Chirurgia ColoRettale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413867
- Sponsor's protocol ID
- No sponsor
- Acronym
- EEA/PPH2011
- Status last verified
- Dec 2013
- First submitted
- 8 Aug 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01413867
- Acronym / sponsor ID
- EEA/PPH2011 / No sponsor
- Conditions
- III Degree Hemorrhoids
- Keywords
- hemorrhoids, circular staplers, mucosal resection, hemostatic suture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.
This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEA group | Experimental | Procedure: stapled hemorrhoidopexyGroup of patients with III degree hemorrhoids treated by EEA stapler |
| PPH group | Active comparator | Procedure: stapled hemorrhoidopexygroup of patients with III degree hemorrhoids treated by PPH stapler |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- III degree Hemorrhoids
- written informed consent
- mental ability to understand the procedure
Key exclusion criteria (6 listed)
- Previous treatments for hemorrhoids or other proctological diseases
- Fecal Incontinence
- Chronic inflammatory bowel disease
- Anal sphincter lesions
- coagulative defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stapled hemorrhoidopexystapled hemorrhoidopexy will be performed using the EEA stapler Covidien | Procedure or surgery | EEA group |
| stapled hemorrhoidopexystapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery | Procedure or surgery | PPH group |
Primary outcome
quantity of anorectal mucosa resected using two different circular staplers
Time frame: 1 hour following the end of the operation
The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared
1 secondary outcome
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers
Time frame: 1 hour after each operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
Related trials for III Degree Hemorrhoids
Recruiting
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Hemorrhoids Third Degree, Internal Hemorrhoids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stapled hemorrhoidopexy in people with III Degree Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantity of anorectal mucosa resected using two different circular staplers (time frame: 1 hour following the end of the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.