LigaSure or Diathermy Excision of III-IV Degree Pile
Primary Purpose
Pile
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Compare between two procedure for II-IV degree pile excision
Sponsored by
About this trial
This is an interventional health services research trial for Pile focused on measuring ligaSure, pile, diathermy, hamemorrdectomy, grade II-IV pile
Eligibility Criteria
Inclusion Criteria:
III-IV degree pile Prolapsed, irreducible pile
Exclusion Criteria:
I-II degree pile Internal pile
Sites / Locations
- Samer Al-Hakkak
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I LigaSure (n=100)
Group II Conventional diathermy (n=108)
Arm Description
100 patients subjected to LigaSure pile excision
108 patients subjected to conventional diathermy for grade IV pile excision
Outcomes
Primary Outcome Measures
postoperative pain,complication, time return to home activity
LigaSure better than diathermy in grade II-IV pile excision
Secondary Outcome Measures
Full Information
NCT ID
NCT05223296
First Posted
January 4, 2022
Last Updated
January 25, 2022
Sponsor
Jabir Ibn Hayyan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05223296
Brief Title
LigaSure or Diathermy Excision of III-IV Degree Pile
Official Title
LigaSure or Diathermy Excision of III-IV Degree Pile? A Single-institution Experience: Randomized Control Trials
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
January 19, 2020 (Actual)
Study Completion Date
December 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jabir Ibn Hayyan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pile
Keywords
ligaSure, pile, diathermy, hamemorrdectomy, grade II-IV pile
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I LigaSure (n=100)
Arm Type
Active Comparator
Arm Description
100 patients subjected to LigaSure pile excision
Arm Title
Group II Conventional diathermy (n=108)
Arm Type
Active Comparator
Arm Description
108 patients subjected to conventional diathermy for grade IV pile excision
Intervention Type
Device
Intervention Name(s)
Compare between two procedure for II-IV degree pile excision
Intervention Description
LigaSure or diathermy excision of III-IV degree pile?
Primary Outcome Measure Information:
Title
postoperative pain,complication, time return to home activity
Description
LigaSure better than diathermy in grade II-IV pile excision
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
III-IV degree pile Prolapsed, irreducible pile
Exclusion Criteria:
I-II degree pile Internal pile
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel Al-Mayely, Ph.D.
Organizational Affiliation
Jabir Ibn Hayyan Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Samer Al-Hakkak
City
Najaf
State/Province
An Najaf
ZIP/Postal Code
00964
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LigaSure or Diathermy Excision of III-IV Degree Pile
We'll reach out to this number within 24 hrs