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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2010-A00642-37 | Other Identifier | Afssaps |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DGALM | Experimental | doppler-guided arterial ligation with mucopexy |
|
| SH | Active Comparator | stapled haemorrhoidopexy according to Longo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doppler-guided arterial ligation with mucopexy | Device | doppler-guided arterial ligation with mucopexy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 60-90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of the 2 procedures | global cost of the treatment, length of stay, sick leave, cost of complications and sequelae management | 12 months |
| Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Angers | 49033 | France | |||
| Grenoble University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32460882 | Derived | 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. | |
| 29808305 | Derived | Venara 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. |
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| stapled haemorrhoidopexy according to Longo | Device | stapled haemorrhoidopexy according to Longo |
|
Efficiency regarding the cure of haemorrhoidal symptoms that led to surgery
| 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 | 1 year |
| Grenoble |
| France |
| La Roche/Yon Hospital | La Roche/Yon | France |
| Lille University Hospital "Claude Huriez" | Lille | France |
| Marseille University Hospital "Hôpital Nord" | Marseille | France |
| Marseille University Hospital "La Timone" | Marseille | France |
| Nantes University Hospital | Nantes | 44000 | France |
| Niort Hospital | Niort | France |
| Nîmes University Hospital | Nîmes | France |
| Polyclinic H. MALARTIC | Ollioules | France |
| "Institut Mutualiste Montsouris" | Paris | France |
| Hopital St Joseph | Paris | France |
| Poissy / Saint-Germain en Laye Hospital | Poissy | France |
| Rennes University Hospital | Rennes | France |
| Saint-Etienne University Hospital | Saint-Etienne | France |
| "Pôle Hospitalier Mutualiste" | Saint-Nazaire | France |
| Strasbourg University Hospital | Strasbourg | France |
| Foch Hospital | Suresnes | France |
| Talence Bagatelle Hospital | Talence | France |
| Toulouse University Hospital | Toulouse | France |
| Tours University Hospital | Tours | France |
| Vichy Hospital | Vichy | France |
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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