HemorrhoidsNCT01647763
Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
A study testing Hemorrhoidal artery ligation with rectoanal repair and Stapled hemorrhoidopexy in people with Hemorrhoids, run by Cantonal Hospital of St. Gallen at 2 sites in Switzerland.
Trial summary
Background: Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Hemorrhoidal artery ligation with rectoanal repair and Stapled hemorrhoidopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2011to Dec 2024
- Phase
- Interventional
- 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
- hemorrhoids grade 3
- no active anti-coagulation treatment
- no hemorrhoidal recurrence
- no previous surgery on rectum or anus
- no previous local radiotherapy
- no mental incapacities, good study compliance can be expected
Show all 10Show fewer
- no severe incontinence (Wexner score > 12)
- no severe comorbidities
- no inflammatory anal diseases (abscesses, fistulas)
- informed consent
Who cannot join
- patient wish
- inoperability with the assigned intervention, switching to other treatment method
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kantonsspital Rorschach
_Rorschach, 9400
Kantonsspital St. Gallen
Sankt Gallen, 9007
About this study
Background:
Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain.
Read more
Hypothesis and aim:
The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.
- Conditions
- Hemorrhoids
- Being tested
- Hemorrhoidal artery ligation with rectoanal repair, Stapled hemorrhoidopexy
- Keywords
- Hemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoidal artery ligation with rectoanal repairProcedure or surgery
Also called HAL (hemorrhoidal artery ligation), RAR (rectoanal repair)
Hemorrhoidal arteries will be detected using an ultrasound Doppler probe. The arteries will be sutured with at least 4 Z-sutures.
In the area with the 3 largest knots a purse string suture will be placed.
Stapled hemorrhoidopexyProcedure or surgery
Also called Longo procedure
A purse string suture will be placed just below the hemorrhoidal cushion. Fixing the suture around the shaft of a circular PPH 03 stapler (Ethicon Endo-Surgery). Hemorrhoids will be removed by firing the stapler. Sufficiency of the stapler line will be examined through a proctoscope. Eventual sources of bleeding will be sutured.
| Study group | Role | What they receive |
|---|---|---|
| HAL/RAR | Experimental | hemorrhoidal artery ligation with rectoanal repair Receives: Procedure: Hemorrhoidal artery ligation with rectoanal repair |
| Stapled hemorrhoidopexy | Active comparator | procedure for prolapse and hemorrhoids (PPH)
Resection using a circular stapler Receives: Procedure: Stapled hemorrhoidopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain POD1
Visual analogue scale (VAS).
Additionally recording of the pain medication used.
Measured: between 6:00 am and 8:00 am the day after surgery
Secondary outcomes (9)
Pain after 8h
Measuring post operative pain using the visual analogue scale (0 - 10).
Additionally recording of the pain medication used.
Measured: 8 hours after surgery
Pain 30d
visual analogue scale
Measured: 30 days after surgery
Pain 1y
visual analogue scale
Measured: 1 year after surgery
Pain 2y
visual analogue scale
Measured: 2 years after surgery
post operative surgical complications
Number and severity according to the Dindo classification (Ann Surg 240:205)
Measured: within 30 post operative days
duration of medical leave
data will be obtained from primary care physician
Measured: up to 3 months after surgery
Continence 30d
Physician obtains data to calculate the Wexner Score (Dis Colon Rectum 36:77).
Score will be compared with pre-operative score.
Measured: 30 days after surgery
Continence 1y
Wexner score
Measured: 1 year after surgery
Continence 2y
Wexner score
Additionally anorectal manometry (results will be compared with pre-operative data).
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2022
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Marti, Cantonal Hospital of St. Gallen
- Investigators
- Lukas Marti, MD, Principal investigator, Cantonal Hospital St. Gallen, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647763
- Sponsor's protocol ID
- EKSG11/042
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2012
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
- ClinicalTrials.gov ID
- NCT01647763
- Acronym / sponsor ID
- EKSG11/042
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Jul 2012 (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.
Background:
Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain.
Hypothesis and aim:
The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAL/RAR | Experimental | Procedure: Hemorrhoidal artery ligation with rectoanal repairhemorrhoidal artery ligation with rectoanal repair |
| Stapled hemorrhoidopexy | Active comparator | Procedure: Stapled hemorrhoidopexyprocedure for prolapse and hemorrhoids (PPH) Resection using a circular stapler |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- hemorrhoids grade 3
- no active anti-coagulation treatment
- no hemorrhoidal recurrence
- no previous surgery on rectum or anus
- no previous local radiotherapy
Key exclusion criteria (2 listed)
- patient wish
- inoperability with the assigned intervention, switching to other treatment method
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 |
|---|---|---|
| Hemorrhoidal artery ligation with rectoanal repairAlso: HAL (hemorrhoidal artery ligation), RAR (rectoanal repair)Hemorrhoidal arteries will be detected using an ultrasound Doppler probe. The arteries will be sutured with at least 4 Z-sutures. In the area with the 3 largest knots a purse string suture will be placed. | Procedure or surgery | HAL/RAR |
| Stapled hemorrhoidopexyAlso: Longo procedureA purse string suture will be placed just below the hemorrhoidal cushion. Fixing the suture around the shaft of a circular PPH 03 stapler (Ethicon Endo-Surgery). Hemorrhoids will be removed by firing the stapler. Sufficiency of the stapler line will be examined through a proctoscope. Eventual sources of bleeding will be sutured. | Procedure or surgery | Stapled hemorrhoidopexy |
Primary outcome
Pain POD1
Time frame: between 6:00 am and 8:00 am the day after surgery
Visual analogue scale (VAS). Additionally recording of the pain medication used.
9 secondary outcomes
Pain after 8h
Time frame: 8 hours after surgery
Pain 30d
Time frame: 30 days after surgery
Pain 1y
Time frame: 1 year after surgery
Pain 2y
Time frame: 2 years after surgery
post operative surgical complications
Time frame: within 30 post operative days
duration of medical leave
Time frame: up to 3 months after surgery
Continence 30d
Time frame: 30 days after surgery
Continence 1y
Time frame: 1 year after surgery
Continence 2y
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Website of the Department of Surgery (in German only)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
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.
Lukas Marti, MD principal investigator
Cantonal Hospital St. Gallen, Department of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidal artery ligation with rectoanal repair and Stapled hemorrhoidopexy in people with Hemorrhoids, run by Cantonal Hospital of St. Gallen at 2 sites in Switzerland.
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 10 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
Are results available for this study?
Results are not available in the source record.
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?
Pain POD1 (time frame: between 6:00 am and 8:00 am the day after surgery). 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 8 Aug 2023.