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Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938714
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Safia Zahir Ahmed, Services Hospital, Lahore

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.

Condition or disease Intervention/treatment Phase
Hemorrhoidectomy Third Degree Hemorrhoids Fourth Degree Hemorrhoids Operative Time Postoperative,Pain Length of Stay Procedure: Hemorrhoidectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Coagulating Shears ® model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Actual Study Start Date : August 27, 2015
Actual Primary Completion Date : February 26, 2016
Actual Study Completion Date : February 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Active Comparator: CH( Conventional Hemorrhoidectomy)
Closed Conventional Hemorrhoidectomy
Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Other Name: Ferguson Closed Hemorrhoidectomy

Experimental: HS( Harmonic Scalpel)
Harmonic Scalpel Hemorrhoidectomy
Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Other Name: Ferguson Closed Hemorrhoidectomy




Primary Outcome Measures :
  1. Operative Time [ Time Frame: The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes ]
    from start of incision to the dressing in minutes

  2. post operative pain [ Time Frame: Each Patient was measured in 24 hours ]
    On Visual analogue scale, a scale to measure pain and it ranges between 0-10. Scale 0-1 means no pain, 2-4 means mild pain,5-7 means moderate pain and 8-10 means severe pain. and it was measured post-operative in 24 hours

  3. Hospital Stay [ Time Frame: the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days ]
    was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (<3)



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

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): NCT03938714


Locations
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Pakistan
services Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Hospital, Lahore
Investigators
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Principal Investigator: Safia Z Ahmed, FCPS Services Hospital

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Responsible Party: Safia Zahir Ahmed, principal Investigator, Services Hospital, Lahore
ClinicalTrials.gov Identifier: NCT03938714    
Other Study ID Numbers: IRB/503/SIMS
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: I want to share the abstract to other researches
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data is available as the study is complete and for 12 month period
Access Criteria: will be shared upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safia Zahir Ahmed, Services Hospital, Lahore:
VAS pain score
Harmonic Scalpel Hemorrhoidectomy
Conventional Hemorrhoidectomy
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases