Clinical trial NCT03848468: Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
Official title: Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2019-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Covidien 5mm ligasure
Primary purpose: TREATMENT

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

Detailed description: INTRODUCTION:

Milligan Morgan hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in ligasure hemorrhoidectomy have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time, wound healing and return to normal activities.

OBJECTIVES:

To compare the outcome of ligasure hemorrhoidectomy with conventional hemorrhoidectomy in III and IV degree hemorrhoids.

STUDY DESIGN:

Randomized controlled trial

STUDY SETTING:

The study was conducted in surgical unit 1, Services hospital, Lahore.

DURATION OF STUDY:

Study was completed in six months after the approval of synopsis i.e. from 1st April 2014 to 30th September 2014.

DATA COLLECTION PROCEDURE:

After approval from hospital ethical committee, 100 patients fulfilling the inclusion criteria has been recruited from outdoor and emergency department. A detailed history had been taken including demographic data (age, address) and all patients had been clinically examined .Patients was divided in two groups randomly using random number tables. Group A: Conventional hemorrhoidectomy. Group B: Ligasure hemorrhoidectomy. Patients had been requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures have been performed by a single surgical operating team to control bias. Preoperatively operative time was noted. Post operatively pain had been assessed after 6 hours, 24 hours, and 48 hours, wound has been assessed in 2nd and 3rd postoperative week to assess epithelization and return to normal activities in days. All data had been collected and recorded on the Proforma

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: operative time
timeFrame: each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes
measure: mean postoperative pain
timeFrame: each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours
measure: wound healing
timeFrame: to assess change in the parameter in 3 weeks
measure: Return to work
timeFrame: assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: services Hospital
state: Punjab
Study officials:
References: