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

Length of Stay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938714
• Other study ID #: IRB/503/SIMS
• Status: Completed
• Phase: N/A
• Start date: August 27, 2015
• Est. completion date: February 28, 2016

Study information

• Verified date: May 2019
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2016
• Est. primary completion date: February 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fourth Degree Hemorrhoids
• Hemorrhoidectomy
• Hemorrhoids
• Length of Stay
• Operative Time
• Postoperative,Pain
• Third Degree Hemorrhoids

Intervention

Procedure:
• Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids

Locations

Country	Name	City	State
Pakistan	services Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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