Symptomatic Haemorrhoidal Disease Requiring Surgical ManagementPhase 3LIGALONGONCT01240772
Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy
A Phase 3 study testing doppler-guided arterial ligation with mucopexy and stapled haemorrhoidopexy according to Longo in people with Symptomatic Haemorrhoidal Disease Requiring Surgical Management, run by Nantes University Hospital at 22 sites in France.
Trial summary
This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Symptomatic Haemorrhoidal Disease Requiring Surgical Management
- What is being tested?
- doppler-guided arterial ligation with mucopexy and stapled haemorrhoidopexy according to Longo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 22 sitesFrance
- Study dates
- Dec 2010to Feb 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (male or female) 18 - 75 y.o
- Suffering from symptomatic grade II or III haemorrhoidal disease (bleeding and/or prolapse)
- requiring surgery
Who cannot join
- Acute complication of haemorrhoidal disease
- History of anal surgery for haemorrhoids
- Congenital or acquirred anal stenosis
- Anal fissure or perianal abcess
- Inflammatory bowel disease
- Colon or rectal cancerv History of rectal or sigmoid resection
Show all 10Show fewer
- Rectal prolapse
- Portal vein hypertension
- Haemophylia
- Pregnancy
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Angers University Hospital
Angers, 49033
Grenoble University Hospital
Grenoble
La Roche/Yon Hospital
La Roche/Yon
Lille University Hospital "Claude Huriez"
Lille
Marseille University Hospital "Hôpital Nord"
Marseille
Marseille University Hospital "La Timone"
Marseille
Nantes University Hospital
Nantes, 44000
Nîmes University Hospital
Nîmes
Niort Hospital
Niort
Polyclinic H. MALARTIC
Ollioules
"Institut Mutualiste Montsouris"
Paris
Hopital St Joseph
Paris
Poissy / Saint-Germain en Laye Hospital
Poissy
Rennes University Hospital
Rennes
Saint-Etienne University Hospital
Saint-Etienne
"Pôle Hospitalier Mutualiste"
Saint-Nazaire
Strasbourg University Hospital
Strasbourg
Foch Hospital
Suresnes
Talence Bagatelle Hospital
Talence
Toulouse University Hospital
Toulouse
Tours University Hospital
Tours
Vichy Hospital
Vichy
About this study
Official title: Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)
This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. With a large number of patients managed in more than 20 centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would demonstrate to be cost-effective for health care system and attractive for patients.
- Being tested
- doppler-guided arterial ligation with mucopexy, stapled haemorrhoidopexy according to Longo
- Keywords
- Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler-guided arterial ligation with mucopexyDevice
Also called THD, AMI
doppler-guided arterial ligation with mucopexy
stapled haemorrhoidopexy according to LongoDevice
stapled haemorrhoidopexy according to Longo
| Study group | Role | What they receive |
|---|---|---|
| DGALM | Experimental | doppler-guided arterial ligation with mucopexy Receives: Device: doppler-guided arterial ligation with mucopexy |
| SH | Active comparator | stapled haemorrhoidopexy according to Longo Receives: Device: stapled haemorrhoidopexy according to Longo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity at 60 days postoperatively of the 2 techniques
Morbidity at 60 days postoperatively of the 2 techniques, the morbidity being defined as " the sum of adverse events that occurred during or after the procedure for a period of 2 months".Primary outcome measure is "the percentage of patients with complication, whatever the number of complications per patient and the grade of complication according to the Clavien-Dindo classification".
Measured: 60-90 days
Secondary outcomes (3)
Cost-effectiveness of the 2 procedures
global cost of the treatment, length of stay, sick leave, cost of complications and sequelae management
Measured: 12 months
Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms
Efficiency regarding the cure of haemorrhoidal symptoms that led to surgery
- Pain
- Persisting or recurring symptoms of haemorrhoidal disease
- Prolapse
- Bleeding
- Haemorrhoidal thrombose
- Occurrence of new anal symptoms / surgical sequelae
- Incontinence
- Soiling
- Pruritus
- Anal stenosis
- Constipation
- Fissure
- Other rare complication
Measured: 1 year
Rate of anatomical or functional sequelae
Assessment will be done according to Grade II vs Grade III patients as well as patients without and with antithrombotic treatments
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Haemorrhoidal Disease Requiring Surgical ManagementStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240772
- Sponsor's protocol ID
- STIC/10/01
- Other IDs
- IDRCB 2010-A00642-37
- Acronym
- LIGALONGO
- Status last verified
- Aug 2014
- First submitted
- 12 Nov 2010
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Woaye-Hune P, Hardouin JB, Lehur PA, Meurette G, Vanier A. Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes. Health Qual Life Outcomes. 2020 May 27;18(1):156. doi: 10.1186/s12955-020-01398-w.
PubMed 32460882Venara A, Podevin J, Godeberge P, Redon Y, Barussaud ML, Sielezneff I, Queralto M, Bourbao C, Chiffoleau A, Lehur PA; LigaLongo Study Group. A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Int J Colorectal Dis. 2018 Oct;33(10):1479-1483. doi: 10.1007/s00384-018-3093-8. Epub 2018 May 28.
PubMed 29808305
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)
- ClinicalTrials.gov ID
- NCT01240772
- Acronym / sponsor ID
- LIGALONGO / STIC/10/01
- Keywords
- Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Nov 2010 (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.
This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. With a large number of patients managed in more than 20 centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would demonstrate to be cost-effective for health care system and attractive for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DGALM | Experimental | Device: doppler-guided arterial ligation with mucopexydoppler-guided arterial ligation with mucopexy |
| SH | Active comparator | Device: stapled haemorrhoidopexy according to Longostapled haemorrhoidopexy according to Longo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient (male or female) 18 - 75 y.o
- Suffering from symptomatic grade II or III haemorrhoidal disease (bleeding and/or prolapse)
- requiring surgery
Key exclusion criteria (10 listed)
- Acute complication of haemorrhoidal disease
- History of anal surgery for haemorrhoids
- Congenital or acquirred anal stenosis
- Anal fissure or perianal abcess
- Inflammatory bowel disease
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 |
|---|---|---|
| doppler-guided arterial ligation with mucopexyAlso: THD, AMIdoppler-guided arterial ligation with mucopexy | Device | DGALM |
| stapled haemorrhoidopexy according to Longostapled haemorrhoidopexy according to Longo | Device | SH |
Primary outcome
Morbidity at 60 days postoperatively of the 2 techniques
Time frame: 60-90 days
Morbidity at 60 days postoperatively of the 2 techniques, the morbidity being defined as " the sum of adverse events that occurred during or after the procedure for a period of 2 months".Primary outcome measure is "the percentage of patients with complication, whatever the number of complications per patient and the grade of complication according to the Clavien-Dindo classification".
3 secondary outcomes
Cost-effectiveness of the 2 procedures
Time frame: 12 months
Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms
Time frame: 1 year
Rate of anatomical or functional sequelae
Time frame: 1 year
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 25 Aug 2014.
- Derived from this study: PubMed 32460882Woaye-Hune P, Hardouin JB, Lehur PA, Meurette G, Vanier A. Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes. Health Qual Life Outcomes. 2020 May 27;18(1):156. doi: 10.1186/s12955-020-01398-w.
- Derived from this study: PubMed 29808305Venara A, Podevin J, Godeberge P, Redon Y, Barussaud ML, Sielezneff I, Queralto M, Bourbao C, Chiffoleau A, Lehur PA; LigaLongo Study Group. A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Int J Colorectal Dis. 2018 Oct;33(10):1479-1483. doi: 10.1007/s00384-018-3093-8. Epub 2018 May 28.
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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doppler-guided arterial ligation with mucopexy and stapled haemorrhoidopexy according to Longo in people with Symptomatic Haemorrhoidal Disease Requiring Surgical Management, run by Nantes University Hospital at 22 sites in France.
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 10 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 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. 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?
Morbidity at 60 days postoperatively of the 2 techniques (time frame: 60-90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240772, which also lists 2 linked publications.
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 25 Aug 2014.