Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles
- Conditions
- Hemorrhoids
- Interventions
- Procedure: open surgical hemorrhoidectomyProcedure: laser hemorrhoidoplasty
- Registration Number
- NCT05770141
- Lead Sponsor
- Assiut University
- Brief Summary
The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy
- Detailed 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- II-III hemorrhoidal disease
- failure of conservative treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MM GROUP open surgical hemorrhoidectomy patients received conventional open surgical hemorrhoidectomy LHP GROUP laser hemorrhoidoplasty patients received Laser Hemorrhoidoplasty procedure
- Primary Outcome Measures
Name Time Method Pain evaluation 30 postoperative days postoperative pain assessment with Visual Analogue Scale Score, The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
bleeding 30 postoperative days The timing of bleeding after hemorrhoidectomy varies, and can be generally divided into immediate and delayed.5 Immediate bleeding occurs within 24 to 48 hours of a procedure and is likely related to loss of control of the vascular pedicle. Delayed bleeding is defined as bleeding reported up to 2 weeks postprocedure, and is more often related to infection or local trauma , patients often report frequent passing of small to moderate amounts of clot and bright red blood starting after bowel movement.
- Secondary Outcome Measures
Name Time Method Presence of recurrence 6 months Patients were considered to have recurrent hemorrhoidal symptoms when any of the following were recorded: bleeding, itching, pain or discomfort affecting patient's perception of quality of life, which could either be associated or not to prolapse recurrence.