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出境医 / 临床实验 / Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique

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

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 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.

Study Design
Layout table for study information
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
Arms and Interventions
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

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
Layout table for eligibility information
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).
Contacts and Locations

Locations
Layout table for location information
Pakistan
services Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Hospital, Lahore
Investigators
Layout table for investigator information
Principal Investigator: Safia Z Ahmed, FCPS Services Hospital
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE August 27, 2015
Actual Primary Completion Date February 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • 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
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Official Title  ICMJE Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Coagulating Shears ® model
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemorrhoidectomy
  • Third Degree Hemorrhoids
  • Fourth Degree Hemorrhoids
  • Operative Time
  • Postoperative,Pain
  • Length of Stay
Intervention  ICMJE Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Other Name: Ferguson Closed Hemorrhoidectomy
Study Arms  ICMJE
  • Active Comparator: CH( Conventional Hemorrhoidectomy)
    Closed Conventional Hemorrhoidectomy
    Intervention: Procedure: Hemorrhoidectomy
  • Experimental: HS( Harmonic Scalpel)
    Harmonic Scalpel Hemorrhoidectomy
    Intervention: Procedure: Hemorrhoidectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2016
Actual Primary Completion Date February 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938714
Other Study ID Numbers  ICMJE IRB/503/SIMS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: I want to share the abstract to other researches
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: data is available as the study is complete and for 12 month period
Access Criteria: will be shared upon request
Responsible Party Safia Zahir Ahmed, Services Hospital, Lahore
Study Sponsor  ICMJE Services Hospital, Lahore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Safia Z Ahmed, FCPS Services Hospital
PRS Account Services Hospital, Lahore
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP