Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
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|ClinicalTrials.gov Identifier: NCT03848468|
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoidectomy Hemorrhoids Third Degree Hemorrhoids Fourth Degree Operative Time Pain, Postoperative Wound Healing Return to Work||Procedure: Hemorrhoidectomy||Not Applicable|
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.
To compare the outcome of ligasure hemorrhoidectomy with conventional hemorrhoidectomy in III and IV degree hemorrhoids.
Randomized controlled trial
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Covidien 5mm ligasure|
|Masking:||None (Open Label)|
|Official Title:||Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.|
|Actual Study Start Date :||April 1, 2014|
|Actual Primary Completion Date :||September 30, 2014|
|Actual Study Completion Date :||September 30, 2014|
Active Comparator: CH(conventional Hemorrhoidectomy)
excision of 3rd and 4th degree hemorrhoids
Experimental: LH (Ligasure Hemorrhoidectomy)
excision of 3rd and 4th degree hemorrhoids
- operative time [ Time Frame: each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes ]was measured from start of incision to the dressing in minutes
- mean postoperative pain [ Time Frame: each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours ]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
- wound healing [ Time Frame: to assess change in the parameter in 3 weeks ]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
- Return to work [ Time Frame: assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848468
|Lahore, Punjab, Pakistan, 54000|