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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

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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Open Haemorrhoidectomy Procedure: LigaSure Hemorrhoidectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Active Comparator: Minimal open hemorrhoidectomy
Patients randomized to Minimal open hemorrhoidectomy
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

Active Comparator: LigaSure hemorrhoidectomy
Patients randomized to LigaSure 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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.


  4. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139876


Contacts
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Contact: Andre H Campos, MD 004559484000 ahca@regionsjaelland.dk
Contact: Per Olov Gunnar Olaison, MD, pHD 004559484000 poo@regionsjaelland.dk

Locations
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Denmark
Departement of Surgery, Holbaek County Hospital. Recruiting
Holbaek, Denmark, 4300
Contact: Andre H Campos, MD    004559484000    ahca@regionsjaelland.dk   
Contact: Per Olov Gunnar Olaison, MD, pHD    004559484000    poo@regionsjaelland.dk   
Sponsors and Collaborators
Holbaek Sygehus
Investigators
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Study Director: Per Olov Gunnar Olaison, MD, pHD Department of Surgery, Holbaek County Hospital
  Study Documents (Full-Text)

Documents provided by André Heiner dos Santos Campos, Holbaek Sygehus:
Publications:
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Responsible Party: André Heiner dos Santos Campos, MD, Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT04139876    
Other Study ID Numbers: Holbaek
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by André Heiner dos Santos Campos, Holbaek Sygehus:
Hemorrhoidectomy
Minimal Open hemorrhoidectomy
LigaSure hemorrhoidectomy
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases