NCT03938714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 3, 2019

Last Update Submit

May 3, 2019

Conditions

HemorrhoidectomyThird Degree HemorrhoidsFourth Degree HemorrhoidsOperative TimePostoperative,PainLength of Stay

Keywords

VAS pain scoreHarmonic Scalpel HemorrhoidectomyConventional Hemorrhoidectomy

Outcome Measures

Primary Outcomes (3)

  • Operative Time

    from start of incision to the dressing in minutes

    The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes

  • post operative pain

    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

    Each Patient was measured in 24 hours

  • Hospital Stay

    was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (\<3)

    the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days

Study Arms (2)

CH( Conventional Hemorrhoidectomy)

ACTIVE COMPARATOR

Closed Conventional Hemorrhoidectomy

Procedure: Hemorrhoidectomy

HS( Harmonic Scalpel)

EXPERIMENTAL

Harmonic Scalpel Hemorrhoidectomy

Procedure: Hemorrhoidectomy

Interventions

HemorrhoidectomyPROCEDURE

Excision of third and fourth degree hemorrhoids

Also known as: Ferguson Closed Hemorrhoidectomy
CH( Conventional Hemorrhoidectomy)HS( Harmonic Scalpel)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

services Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Safia Z Ahmed, FCPS

    Services Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Coagulating Shears ® model
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 6, 2019

Study Start

August 27, 2015

Primary Completion

February 26, 2016

Study Completion

February 28, 2016

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

I want to share the abstract to other researches

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations

PA(1)