Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.

NCT03848468 | Completed DMC

• 1 other identifier: ServicesH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A comparison study was performed between Ligasure and Milligan morgan hemorrhoidectomy to find out the outcome between these two techniques in 3rd and 4th degree hemorrhoids.This advance vessel sealing device is used to seal the pedicle of the vessel and does not burn the surrounding tissues , so the outcome was monitored in terms of operative time, post operative pain pain, duration of wound healing in 3 weeks and return to normal activities

Conditions

Hemorrhoidectomy; Hemorrhoids Third Degree; Hemorrhoids Fourth Degree; Operative Time; Pain, Postoperative; Wound Healing; Return to Work

Keywords

Visual Analogue pain score; conventional Hemorrhoidectomy; Ligasure Hemorrhoidectomy

Outcome Measures

Primary Outcomes (4)

• operative time

  was measured from start of incision to the dressing in minutes

  each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes

• mean postoperative pain

  on Visual analogue scale,a scale to assess the post operative pain ,8-10 as maximum pain, 5-7 as moderate pain, 2-4 minimum pain, 1-0 as no pain and change in final outcome has been assessed after 48 hours

  each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours

• wound healing

  assessed in scheduled appointment every week and has been defined as complete epithelization on physical examination .Wound was graded as 1-sloughy, 2-no granulation, 3-granulation, 4-epithelizing , 5-completely epithelized

  to assess change in the parameter in 3 weeks

• Return to work

  has been defined as day of discharge till resume of work that is patient is able to perform daily routine activities normally as before operation.

  assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days

Study Arms (2)

CH(conventional Hemorrhoidectomy)

ACTIVE COMPARATOR

conventional hemorrhoidectomy

Procedure: Hemorrhoidectomy

LH (Ligasure Hemorrhoidectomy)

EXPERIMENTAL

Ligasure hemorrhoidectomy

Procedure: Hemorrhoidectomy

Interventions

Hemorrhoidectomy PROCEDURE

excision of 3rd and 4th degree hemorrhoids

CH(conventional Hemorrhoidectomy); LH (Ligasure Hemorrhoidectomy)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with III and IV degree hemorrhoids assessed on proctoscopy had been included in this study.

You may not qualify if:

• Patients with permanently prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
• Any other anorectal pathology on history and per rectal examination
• Previous anal surgery assessed by history and per rectal examination
• Inability to give informed consent
• ASA(American Society of Anesthesiologists) grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic and renal profile and evidence of ischemic heart disease

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

services Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Covidien 5mm ligasure

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 20, 2019
• Study Start: April 1, 2014
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

PA (1)