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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03938714

Recruitment Status Completed

First Posted May 6, 2019

Last update posted May 6, 2019

Study Description

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:Third Degree Hemorrhoids
    Hemorrhoidectomy
    Fourth Degree Hemorrhoids
    Operative Time
    Postoperative,Pain
    Length of Stay
  • Intervention/Treatment: Procedure: Hemorrhoidectomy
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2015
  • Actual Primary Completion Date: February 2016
  • Actual Study Completion Date: February 2016
Arms and interventions
Arm Intervention/treatment
Active Comparator: CH( Conventional Hemorrhoidectomy)
Closed Conventional Hemorrhoidectomy
Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Experimental: HS( Harmonic Scalpel)
Harmonic Scalpel Hemorrhoidectomy
Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Outcome Measures
  • 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)
Eligibility Criteria
  • Ages Eligible for Study: 20 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).

Contacts and Locations
Contacts
Locations

Pakistan, Punjab
services Hospital
Lahore

Sponsors and Collaborators

Services Hospital, Lahore

Investigators

Principal Investigator: Safia Z Ahmed, FCPS Services Hospital

More Information
  • Responsible Party: Services Hospital, Lahore
  • ClinicalTrials.gov Identifier: NCT03938714 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Services Hospital, Lahore: VAS pain score
    Harmonic Scalpel Hemorrhoidectomy
    Conventional Hemorrhoidectomy
  • Additional relevant MeSH terms: Hemorrhoids