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Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy

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ClinicalTrials.gov Identifier: NCT04139876
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
André Heiner dos Santos Campos, Holbaek Sygehus

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date October 29, 2019
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • Patient satisfaction assessed by a seven grade Likert Scale. [ Time Frame: Preoperatively (baseline) and 1 year postoperatively ]
    At follow-up patients grade their satisfaction with the operation on a seven-point Likert scale (1= very unsatisfied, 7 = very satisfied).
  • Hemorrhoidal affection of the patient's daily life assessed by Short Health Scale adapted to hemorrhoidal disease (SHSHD). [ Time Frame: Preoperatively (baseline) and 1 year postoperatively ]
    SHSHD consist of four questions graded on a 7-point Likert scale. The questions deal with how the patients symptoms caused by hemorrhoids affect the patients daily life.
    1. - Overall symptom load (1 = no symptoms, 7 = severe symptoms),
    2. - Interference with daily activities (1 = not at all, 7 = interfere to a very high degree)
    3. - Worries caused by HD (1 = no concerns, 7 = constant concerns)
    4. - General well-being (1 = very good, 7 = very bad) The points of each question are summed giving a total score ranging from 4 to 28. (See reference).
  • Anal continence (gas and solids) assessed by the Wexner incontinence scale. [ Time Frame: Preoperatively (baseline) and 1 year postoperatively ]
    Wexner incontinence scale consists of five questions on fecal incontinence graded on a five-point Likert scale from 0 to 4. The points of each question are summed giving a total score ranging from 0 to 20. Zero meaning no incontinence and 20 complete incontinence.
  • Fecal continence assessed by the Revised Fecal Incontinence Scale (RFIS). [ Time Frame: Preoperatively (baseline) and 1 year postoperatively ]
    RFIS consists of five questions on fecal incontinence graded on a five-point Likert scale from 0 to 4. The points of each question are summed giving a total score ranging from 0 to 20. Zero meaning no fecal incontinence and twenty total fecal incontinence.
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.

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.

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
Condition  ICMJE Hemorrhoids
Intervention  ICMJE
  • Procedure: Open Haemorrhoidectomy
    Patient operated in the lithotomy position. The external components are grasped by clamps using gentle traction. Diathermy is used for dissection and hemostasis. The skin is incised midway to one-third of the distance from the top of the pedicle, thus, minimizing the skin excision. The subdermal fascia continuing into a submucosal fascia covering the internal anal sphincter is identified as are fibers passing between the hemorrhoid (H) and this fascia. The H is dissected free from the underlying internal sphincter in this plane, leaving the sphincter unharmed. The anal mucosa is incised at the transition from anal mucosa to hemorrhoidal mucosa and only anal mucosa overlying the H is excised. Only the caudal part of the H is excised. With the H held with gentle traction it is divided at the anal orifice. There will thus be a residual part of the H intra-anally with its caudal end 1-2 cm proximal to the anal orifice.
    Other Names:
    • Milligan Morgan
    • Minimal open Hemorrhoidectomy
    • Hemorrhoidectomy
  • Procedure: LigaSure Hemorrhoidectomy
    Patient is operated in the lithotomy position. The main haemorrhoidal (H) masses are identified and delineated. The H are prolapsed out from the anal canal with Allis clamps or similar pick up forceps. Tension is applied to visualise the junction between the nodule and the mucosal wall (internal) or the perianal tissue (external). A small V-shaped anodermal seal is performed by applying the LigaSure (LS) forceps close to the edge of each pile. The seal is then transacted with scissors along the line of coagulum. Care should be taken to limit the amount of tissue removed to minimize the stricture risk. Repeated applications of the device are performed and the excision is continued into the anal canal, lifting the pile from the internal anal sphincter to the level of the vascular pedicle that is finally sealed by LS and divided.
Study Arms  ICMJE
  • Active Comparator: Minimal open hemorrhoidectomy
    Patients randomized to Minimal open hemorrhoidectomy
    Intervention: Procedure: Open Haemorrhoidectomy
  • Active Comparator: LigaSure hemorrhoidectomy
    Patients randomized to LigaSure hemorrhoidectomy
    Intervention: Procedure: LigaSure Hemorrhoidectomy
Publications * Rørvik 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.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
  • The patient has a Haemorrhoidal Symptom Score of 4 or more
  • The patient has an American Society of Anaesthesiologists (ASA) score I-II
  • The patient's age is 18-85 years at inclusion
  • The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion

Exclusion Criteria:

  • The patient has had previous operation for haemorrhoids within the last 2 years
  • The patient has had previous operation for anal incontinence
  • The patient has an active anal fistula
  • The patient has an active anal fissure
  • The patient has anal incontinence for solid stools
  • Active immunosuppressive therapy (increased risk of anorectal sepsis)
  • Cirrhosis / portal hypertension
  • Mb Crohn.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andre H Campos, MD 004559484000 ahca@regionsjaelland.dk
Contact: Per Olov Gunnar Olaison, MD, pHD 004559484000 poo@regionsjaelland.dk
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party André Heiner dos Santos Campos, Holbaek Sygehus
Study Sponsor  ICMJE Holbaek Sygehus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Per Olov Gunnar Olaison, MD, pHD Department of Surgery, Holbaek County Hospital
PRS Account Holbaek Sygehus
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP