Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy
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ClinicalTrials.gov Identifier: NCT04139876 |
Recruitment Status : Unknown
Verified April 2022 by André Heiner dos Santos Campos, Holbaek Sygehus.
Recruitment status was: Recruiting
First Posted : October 25, 2019
Last Update Posted : April 19, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | October 4, 2019 | ||||
First Posted Date ICMJE | October 25, 2019 | ||||
Last Update Posted Date | April 19, 2022 | ||||
Actual Study Start Date ICMJE | March 1, 2017 | ||||
Estimated Primary Completion Date | December 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS). [ Time Frame: 1 year postoperatively ] The HDSS consists of five items on patient-reported frequency of pain, itching, bleeding, soiling and prolapse. Each symptom graded on a five-point scale (0=never, 1=less than once a month, 2=less than once a week, 3=1-6 days per week, 4=every day / always), giving a total score ranging from 0-20. Zero meaning no symptoms. (See reference).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy | ||||
Official Title ICMJE | Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms | ||||
Brief Summary | This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS). Secondary endpoints are patient satisfaction with the operation, Health related Quality of Life and effect on anal continence. |
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Detailed Description | Background Hemorrhoids is one of the oldest known medical conditions. Description of hemorrhoids is found as early as 2250 Before Christ (BC) in the code of king Hammurabi in Babylon. Even though first recorded treatment is thought to be found in the "Edwin Smith Papyrus" from 1700 BC as of today the treatment of this benign state is still debated. A wide range of prevalence rates of hemorrhoids have been stated in part because of the varying definition ,but the general consensus is that hemorrhoidal disease is a common anorectal disease affecting the quality of life of millions of people worldwide. Operation for hemorrhoid is one of the most common operations for benign disease in Denmark. Hemorrhoids arise from the normal vascular structures in the anal canal also referred to as anal cushions or sinusoids as they do not contain muscular cells like arteries or veins. These cushions are typically arranged in three main columns or piles in the anal canal forming an important part of the intricate mechanism of the anal canal preventing incontinence. Hemorrhoids is a pathologic term describing the symptomatic abnormal downward displacement and enlargement of the anal cushions. The term hemorrhoidal disease is used when the hemorrhoids cause symptoms. Treatment of hemorrhoidal disease consists of conservative management with lifestyle and diet changes or local treatment, minor surgery and surgical treatment depending on the severity of disease and symptoms. The staging of internal hemorrhoids in four categories by the Goligher classification is the classification that generally forms the basis of the treatment in Denmark. Local treatment consists of corticosteroids and anaesthetic ointments. Minor surgery includes rubber band ligation and sclerotherapy. Operation is reserved for subjects with prolapse, Goligher grade II and IV. Grade II hemorrhoids may be treated by operation if still symptomatic after banding or sclerosing. The gold standard in the operative treatment of hemorrhoidal is the Milligan-Morgan Hemorrhoidectomy also referred to as hemorrhoidal excision or Open Hemorrhoidectomy (OH). The operation can also be performed as a Closed Hemorrhoidectomy when the wound is closed with sutures (Ferguson's Hemorrhoidectomy). The conventional excisional operation has been associated with postprocedural pain and delayed healing of wounds. In recent years there have been suggestions for and a development toward a less traumatic Open Hemorrhoidectomy. Injuries to the internal anal sphincter during dissection is thought to be one cause for pain. The less traumatic operations include dissection of the hemorrhoid preserving the fascia over the internal anal sphincter and also smaller excision of skin and mucosa - the technique used in this study is described in more detail under Methods. Several new procedures have been proposed in the last decades. Common for all is the implementation of a new technical device, meaning increased operative costs. LigaSure Trademark (TM) hemorrhoidectomy (LH) is a hemorrhoidectomy performed with the use of the LigaSure TM instrument in stead of the traditional diathermy. The LigaSure TM technology patented in 1998 as "Energy Delivery System for Vessel Sealing" creates vessel fusion by a combination of pressure and energy17. The LigaSure device excises the hemorrhoids and seals the wound in the same procedure delivering the energy in a controlled way between the diathermy forceps theoretically limiting thermal spray and tissue charring. Rationale Hemorrhoidal Disease is a benign disease and should be evaluated by it's effect on hemorrhoidal symptoms together with its effect on quality of life. Hemorrhoidal symptoms should be the main outcome variable when evaluating surgery for hemorrhoidal disease. This information is largely lacking. The use of a validated symptom score with long term follow-up could yield important information for the choice of treatment of haemorrhoidal disease. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective Randomized Study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Hemorrhoids | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
70 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2023 | ||||
Estimated Primary Completion Date | December 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Denmark | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04139876 | ||||
Other Study ID Numbers ICMJE | Holbaek | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | André Heiner dos Santos Campos, Holbaek Sygehus | ||||
Original Responsible Party | André Heiner dos Santos Campos, Holbaek Sygehus, MD, Department of Surgery | ||||
Current Study Sponsor ICMJE | Holbaek Sygehus | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Holbaek Sygehus | ||||
Verification Date | April 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |