Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy

NCT04139876 | Unknown

• 1 other identifier: Holbaek
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Keywords

Hemorrhoidectomy; Minimal Open hemorrhoidectomy; LigaSure hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

• Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS).

  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).

  1 year postoperatively

Secondary Outcomes (4)

• Patient satisfaction assessed by a seven grade Likert Scale.

  Preoperatively (baseline) and 1 year postoperatively

• Hemorrhoidal affection of the patient's daily life assessed by Short Health Scale adapted to hemorrhoidal disease (SHSHD).

  Preoperatively (baseline) and 1 year postoperatively

• Anal continence (gas and solids) assessed by the Wexner incontinence scale.

  Preoperatively (baseline) and 1 year postoperatively

• Fecal continence assessed by the Revised Fecal Incontinence Scale (RFIS).

  Preoperatively (baseline) and 1 year postoperatively

Study Arms (2)

Minimal open hemorrhoidectomy

ACTIVE COMPARATOR

Patients randomized to Minimal open hemorrhoidectomy

Procedure: Open Haemorrhoidectomy

LigaSure hemorrhoidectomy

ACTIVE COMPARATOR

Patients randomized to LigaSure hemorrhoidectomy

Procedure: LigaSure Hemorrhoidectomy

Interventions

Open Haemorrhoidectomy PROCEDURE

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.

Also known as: Milligan Morgan, Minimal open Hemorrhoidectomy, Hemorrhoidectomy

Minimal open hemorrhoidectomy

LigaSure Hemorrhoidectomy PROCEDURE

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.

LigaSure hemorrhoidectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holbaek Sygehus: lead

Study Sites (1)

Departement of Surgery, Holbaek County Hospital.

Holbæk, 4300, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 30451751 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Interventions

Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Per Olov Gunnar Olaison, MD, pHD

  Department of Surgery, Holbaek County Hospital

  STUDY DIRECTOR

Central Study Contacts

Andre H Campos, MD

CONTACT

004559484000; ahca@regionsjaelland.dk

Per Olov Gunnar Olaison, MD, pHD

CONTACT

004559484000; poo@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective Randomized Study

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 25, 2019
• Study Start: March 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)