LigaSure or Diathermy Excision of III-IV Degree Pile

NCT05223296 | Completed DMC

• 1 other identifier: Pile
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Pile

Keywords

ligaSure; pile; diathermy; hamemorrdectomy; grade II-IV pile

Outcome Measures

Primary Outcomes (1)

• postoperative pain,complication, time return to home activity

  LigaSure better than diathermy in grade II-IV pile excision

  two years

Study Arms (2)

Group I LigaSure (n=100)

ACTIVE COMPARATOR

100 patients subjected to LigaSure pile excision

Device: Compare between two procedure for II-IV degree pile excision

Group II Conventional diathermy (n=108)

ACTIVE COMPARATOR

108 patients subjected to conventional diathermy for grade IV pile excision

Device: Compare between two procedure for II-IV degree pile excision

Interventions

Compare between two procedure for II-IV degree pile excision DEVICE

LigaSure or diathermy excision of III-IV degree pile?

Group I LigaSure (n=100); Group II Conventional diathermy (n=108)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• III-IV degree pile Prolapsed, irreducible pile

You may not qualify if:

• I-II degree pile Internal pile

Sponsors & Collaborators

• Jabir Ibn Hayyan Medical University: lead

Study Sites (1)

Samer Al-Hakkak

Najaf, An Najaf, 00964, Iraq

Location

MeSH Terms

Conditions

Hemorrhoids; Fever

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adel Al-Mayely, Ph.D.

  Jabir Ibn Hayyan Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 3, 2022
• Study Start: January 20, 2018
• Primary Completion: January 19, 2020
• Study Completion: December 25, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)