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Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles

A

Assiut University

Status

Not yet enrolling

Conditions

Hemorrhoids

Treatments

Procedure: open surgical hemorrhoidectomy
Procedure: laser hemorrhoidoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT05770141
laser hemorrhoidoplasty

Details and patient eligibility

About

The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Full description

Hemorrhoidal disease is ranked first among diseases of the rectum and large intestine, and the estimated worldwide prevalence ranges from 2.9% to 27.9%, of which more than 4% are symptomatic .

Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years .Men are more frequently affected than women .

The anorectal vascular cushions along with the internal anal sphincter are essential in the maintenance of continence by providing soft tissue support and keeping the anal canal closed tightly. Hemorrhoids are considered to be due to the downward displacement of suspensory (Treitz) muscle .

There are many treatments of hemorrhoids varying from medications and band ligation to stapled hemorrhoidopexy, laser photocoagulation, sclerotherapy, Doppler-guided artery ligation, and finally surgery .

The indications for the surgical treatment include the presence of a significant external component, hypertrophied papillae, associated fissure, extensive thrombosis or recurrence of symptoms after repeated RBL. The technique employed may be open (Milligan-Morgan) or closed (Ferguson) .

Post hemorrhoidectomy pain is the commonest problem associated with the surgical techniques. The other early complications are urinary retention (20.1%), bleeding (secondary or reactionary) (2.4%-6%) and subcutaneous abscess (0.5%). The long-term complications include anal fissure (1% -2.6%), anal stenosis (1%), incontinence (0.4%), fistula (0.5%) and recurrence of hemorrhoids .

The study aims to compare the pain , duration time of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Enrollment

40 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • II-III hemorrhoidal disease
  • failure of conservative treatment

Exclusion criteria

  • grade IV
  • acutely thrombosed haemorrhoids
  • patients affected by IBD involving rectum or anus
  • patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

LHP GROUP
Other group
Description:
patients received Laser Hemorrhoidoplasty procedure
Treatment:
Procedure: laser hemorrhoidoplasty
MM GROUP
Other group
Description:
patients received conventional open surgical hemorrhoidectomy
Treatment:
Procedure: open surgical hemorrhoidectomy

Trial contacts and locations

0

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Central trial contact

Ebram Hakim, doctor

Data sourced from clinicaltrials.gov

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