LigaSure or Diathermy Excision of III-IV Degree Pile

Sponsor
Jabir Ibn Hayyan Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05223296
Collaborator
(none)
208
1
2
47.1
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Compare between two procedure for II-IV degree pile excision
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
LigaSure or Diathermy Excision of III-IV Degree Pile? A Single-institution Experience: Randomized Control Trials
Actual Study Start Date :
Jan 20, 2018
Actual Primary Completion Date :
Jan 19, 2020
Actual Study Completion Date :
Dec 25, 2021

Arms and Interventions

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?

Outcome Measures

Primary Outcome Measures

  1. postoperative pain,complication, time return to home activity [two years]

    LigaSure better than diathermy in grade II-IV pile excision

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

III-IV degree pile Prolapsed, irreducible pile

Exclusion Criteria:

I-II degree pile Internal pile

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samer Al-Hakkak Najaf An Najaf Iraq 00964

Sponsors and Collaborators

  • Jabir Ibn Hayyan Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jabir Ibn Hayyan Medical University
ClinicalTrials.gov Identifier:
NCT05223296
Other Study ID Numbers:
  • Pile
First Posted:
Feb 3, 2022
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jabir Ibn Hayyan Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022