LigaSure or Diathermy Excision of III-IV Degree Pile

LigaSure or Diathermy Excision of III-IV Degree Pile? A Single-institution Experience: Randomized Control Trials

Abstract:

Introduction:

Pile excision is frequently associated with post-operative pain and prolong hospital stay. A modern technique performed with LigaSure appears to be mainly effective in large pile tissue removal is required. The study compares LigaSure pile excision with diathermy for the treatment of III-IV degree pile.

Patients and Methods:

208 patients with pile III or IV degree randomized into 2 groups. Group one LigaSure and group two diathermy. The study evaluates the mean post-operative time, post-operative pain, discharge date, time return to usual works early and late complication. All patient followed-up for range (12-24) months.

Results:

108patient treated by diathermy, 100 by LigaSure. The mean operative time significantly shorter in LigaSure, post-operative pain disappears earlier in LigaSure than diathermy. The time return to work less in LigaSure, while no difference in hospital stay and post-operative complications.

Conclusions:

LigaSure is effective procedure when large degree III or VI pile excised. The procedure enhances to use LigaSure as treatments of choice for class III-IV pile, even it is more expensive than diathermy operation.

Study Overview

• Status: Completed
• Conditions: Pile
• Intervention / Treatment: Device: Compare between two procedure for II-IV degree pile excision

Detailed Description

Surgery remains the mainstay in patients with symptomatic pile grades III and IV. The usual operation by Milligan-Morgan and Ferguson is still most used and effective for symptomatic grades IV and some of grade III. The two procedures get mimicked, like blood loss and postoperative pain, which cause prolonged hospital stay. Rapid wound healing permits the early return to usual works and day activity . Many articles seek the best treatments of piles published in recent years and modern device the procedures trials to overcome the haemorrhoidectomy complication.: like stapling, laser, doppler-guided vessels ligation with different principles aimed at excisional surgery. The LigaSure system vessels sealed were introduced newly in [6] as a tool for treatments of piles. It is a bipolar electro-thermal device; it offers both radiofrequency and pressure. Blood vessels seal up to 7mm in diameter and create energy according to the tissue impendence and confined 2 mm thermal injury over operation site. The limited thermal injury spread decreases the anal spasm and permits bloodless surgery to decrease postoperative pain and promote rapid healing. So the operation is recommended as an ideal procedure because of the significant less tissue trauma . The objective of some randomized trials to estimate the advantage of the LigaSure approach over the conventional diathermy approaches. in spite of the favourite toward the LigaSure, the conclusion gets some uncertainly regarding the cost of using disposable device although an overall favourable trend exists toward LigaSure, conclusions are not univocal and definitive; this creates some uncertainty, also considering the increasing cost for the use of the disposable device so essential to compare our study with another centres to emphasis the true advantage present. The debate is the "gold standard" for III degrees. There are large agreements that Milligan-Morgan and Ferguson are the most effective in IV degree pile . Ortiz mentions that stapled procedure is ineffective for curing itching in an IV degree pile . So the diathermy pile excision continues as an effective therapy for the symptomatic, irreducible and prolapsed pile. The designed study to estimate the LigaSure procedures as effective as conventional diathermy in all grades IV and III with less pain, less blood loss and when we need large tissue excision needed.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • An Najaf
    • Najaf, An Najaf, Iraq, 00964
      • Samer Al-Hakkak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

III-IV degree pile Prolapsed, irreducible pile

Exclusion Criteria:

I-II degree pile Internal pile

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I LigaSure (n=100); 100 patients subjected to LigaSure pile excision	Device: Compare between two procedure for II-IV degree pile excision; LigaSure or diathermy excision of III-IV degree pile?
Active Comparator: Group II Conventional diathermy (n=108); 108 patients subjected to conventional diathermy for grade IV pile excision	Device: Compare between two procedure for II-IV degree pile excision; LigaSure or diathermy excision of III-IV degree pile?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain,complication, time return to home activity	LigaSure better than diathermy in grade II-IV pile excision	two years

Collaborators and Investigators

• Sponsor: Jabir Ibn Hayyan Medical University
• Investigators: Study Director: Adel Al-Mayely, Ph.D., Jabir Ibn Hayyan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): January 19, 2020
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: diathermy; ligaSure; pile; hamemorrdectomy; grade II-IV pile
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia
• Other Study ID Numbers: Pile

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No