To Compare Harmonic Scalpel Surgery Versus Stapled Surgery For Management Of Hemorrhoids

Not yet recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2021/08/035990

Lead Sponsor: Armed Forces Medical College Pune

Brief Summary: Hemorrhoids, more commonly known as Piles, is one of the most common presentations in a surgical OPD. The term â€œhemorrhoidsâ€ was first used by Hippocrates and is derived from the Greek words â€œhaimaâ€, meaning blood, and â€œrheinâ€, meaning flow. The word â€œpilesâ€ was first used to describe the condition by John Ardene and is derived from the Latin word â€œpilaâ€ meaning ball. The theory of sliding anal canal lining is universally accepted as the basis of pathogenesis of hemorrhoids. This theory suggests the disintegration and deterioration of the supporting tissues of the anal cushions as the basis for development of hemorrhoids. Hemorrhoids can be thus be phrased as the pathological term to describe the abnormal downward displacement of the anal cushions causing venous dilatation. The abnormal dilatation and distortion of the vascular channel in conjugation with destructive changes in the supporting connective tissue within the anal cushion is one of the most important pathological findings of hemorrhoids.

Providing adequate care and a definitive treatment to patients has been a challenge for surgeons since antiquity. There are references of treatment of hemorrhoids using cautery by Hippocrates in the ancient times. This must have been an extremely painful ordeal through which the patients had to suffer, before the advent of anaesthesia. Today, the management of hemorrhoidal disease consists of multiple modalities, including dietary and bowel habit modifications, office procedures such as rubber-band ligation and sclerotherapy. Amongst the available surgical modalities, Hemorrhoidectomy is the most definitive treatment.

The Harmonic Scalpel is a device that was first introduced in 1992. It uses ultrasonic energy for cutting tissue, where the blade vibrates at 55500 cycles per second, thereby denaturing the proteins in the tissue. It has been used extensively in many general surgery procedures as it causes minimal thermal damage to the surrounding tissues. Studies have indicated the benefits of harmonic scalpel hemorrhoidectomy over conventional excisional hemorrhoidectomy, owing to various factors like reduced postoperative pain, hospital stay and complications such as haemorrhage, urinary retention, stenosis and incontinence.

Stapled hemorrhoidopexy, a procedure first described by Longo in 1998, has been rapidly emerging as one of the least painful procedures for treatment of hemorrhoids. The procedure involves application of purse-string sutures 3-4 cm above the dentate line, after the reduction of hemorrhoids following which the stapler device is deployed. After this, haemostasis is achieved by electrocautery or suture plication of the bleeding points at the stapled line. Studies have reported reduced post-operative pain and earlier covalence in patients undergoing this procedure, compared to conventional excisional hemorrhoidectomy.

The aim of this study is to compare the two aforementioned modalities in terms of post-operative pain, operating time, intra-operative bleeding, post-operative complications and recurrence rates. This will aid the decision-making process to determine the course of treatment to be offered to patients, and establish standard of care and management for patients suffering from grade 3 and 4 hemorrhoids.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

a)18 years of age or older b) Able to give informed consent c) Adults with symptomatic grade 3 and 4 hemorrhoidal disease.

Exclusion Criteria

a)Patients with thrombosed/gangrenous haemorrhoids b)Patients with deranged coagulation profile c)Patients with presence of anal stenosis, perianal abscess and full thickness rectal prolapse d)Those who had undergone previous anorectal surgery with resultant scarring of the anal canal.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative pain assessment using visual analogue scale and requirement of analgesia	06hrs, 24 hrs, 36 hrs & 72 hrs post-operative period

Secondary Outcome Measures

Name	Time	Method
Intra-operative blood loss (Weight of dry and wet Gauze piece)	Immediate post-op
Operative time (Time Taken for completion of surgery)	Immediate post-op
Post-operative complications (e.g. Bleeding per rectum, Faecal incontinence, Anal stenosis, Recurrence etc.)	6 months from surgery

Trial Locations

Locations (1): Command Hospital (Southern Command)
🇮🇳
Pune, MAHARASHTRA, India
Command Hospital (Southern Command)
🇮🇳Pune, MAHARASHTRA, India
Kshitij Jyoti
Principal investigator
7022254051
kjyoti@icloud.com