Clinical trial NCT03938714: Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Official title: Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoidectomy
Third Degree Hemorrhoids
Fourth Degree Hemorrhoids
Operative Time
Postoperative,Pain
Length of Stay
Keywords: VAS pain score
Harmonic Scalpel Hemorrhoidectomy
Conventional Hemorrhoidectomy
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2019-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Coagulating Shears ® model
Primary purpose: TREATMENT

Brief summary: Hemorrhoidectomy is the treatment of choice for grade 3 and 4th degree hemorrhoids. Various surgical technique has been used to improve the outcome of the procedures performed in respect to operative time ,post operative pain and hospital stay. This study compares the conventional closed technique with harmonic scalpel technique which is a device regulated with ultrasonic waves to perform the procedure with minimal postoperative complication as well as decreasing the prolong stay in hospital.

Detailed description: INTRODUCTION:

Ferguson closed hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in harmonic scalpel have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time and duration of hospital stay.

OBJECTIVES:

To compare the outcome of conventional hemorrhoidectomy versus harmonic scalpel 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 27th August 2015 to 26th February 2016.

DATA COLLECTION PROCEDURE:

After approval from hospital ethical committee, 100 patients fulfilling the inclusion criteria had 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: harmonic scalpel hemorrhoidectomy. Patients had been requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures had been performed by a single surgical operating team to control bias. Per operatively operative time was noted. Post operatively pain had been assessed in 24 hours , mean hospital stay was measured in days from postoperative day till day of discharge (as per operational definition). All data had been collected and recorded on the attached Performa.

Eligibility criteria: Inclusion Criteria:

* Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.

Exclusion Criteria:

* • Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy

  * Any other anorectal pathology such as anal fissure ,fistula or anal cancer on history and per rectal examination
  * Previous anal surgery assessed by history and per rectal examination
  * Inability to give informed consent
  * ASA grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic(AST/ALT \>40IU/L) and renal profile ( creatinine \>1:2mg/dl)and evidence of ischemic heart disease(annexure attached).

Primary outcomes:
measure: Operative Time
timeFrame: The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes
measure: post operative pain
timeFrame: Each Patient was measured in 24 hours
measure: Hospital Stay
timeFrame: the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: services Hospital
state: Punjab
Study officials:
affiliation: Services Hospital
name: Safia Z Ahmed, FCPS
role: PRINCIPAL_INVESTIGATOR
References: