Ligature; HemorrhageNCT03265990
Haemorrhoidectomy by Ligasure and Conventional Surgery
A study testing ligasure haemroidectomy and Conventional haemorrhoidectomy in people with Ligature; Hemorrhage, run by Assiut University.
Trial summary
Comparison between Haemorrhoidectomy by Ligasure and conventional surgery Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ligature; Hemorrhage
- What is being tested?
- ligasure haemroidectomy and Conventional haemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients with ages between 18 to 70 years with symptomatic grade III, or IV hemorrhoid who will be operated on at the Department of general Surgery, Assuit University Hospital
Who cannot join
- age older than 70 years
- patients with Grade I and II haemorrhoids
- patients on anticoagulants
- patients with liver cirrhosis
- patients with the hematological disorder
- patients with the concomitant anal disease
- patients had previous history of anorectal surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery
Comparison between Haemorrhoidectomy by Ligasure and conventional surgery
Read the detailed description
Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture which may lead to some postoperative complications mostly pain, bleeding and wound infection which ultimately cause prolonged stay in hospital.
A number of surgeons believe that by avoiding vascular pedicle ligation the chances of secondary bleeding can be decreased .This stimulated the researchers to develop new techniques with a less severe course and faster recovery . Recent advances in instrumental technology including the bipolar electrothermal device, ultrasonic scalpel, and circular stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these instruments, the LigaSure vessel sealing system has been recently introduced as a tool conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast healing . .Thus this operation can be recommended as the ideal technique. Many trials were performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although an overall favorable trend exists toward LigaSure, conclusions are not univocal and definitive; this creates some uncertainty, also considering the increasing cost for this disposable device: thus it is essential to keep on experimenting to determine whenever an actual advantage exists.
- Conditions
- Ligature; Hemorrhage
- Being tested
- ligasure haemroidectomy, Conventional haemorrhoidectomy
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ligasure haemroidectomyProcedure or surgery
In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.
Conventional haemorrhoidectomyProcedure or surgery
According to the Ferguson technique
- Manual anal sphincter stretching up to 4 fingers
- Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex.
- skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter.
After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Conventional haemrrhoidectomy,Ferguson technique Receives: Procedure: Conventional haemorrhoidectomy |
| Group B | Experimental | Ligasure haemorrhoidectomy Receives: Procedure: ligasure haemroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
pain will be evaluated with visual analogue scale
Measured: 1 month
Secondary outcomes (2)
Intra operative blood loss
Amount of blood loss by cc during surgery
Measured: 1 day
Wound healing
the healing of mucosa and skin
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligature; HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Refaay Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265990
- Sponsor's protocol ID
- ligaHaemorrhoidectomy
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery
- ClinicalTrials.gov ID
- NCT03265990
- Acronym / sponsor ID
- ligaHaemorrhoidectomy
- Conditions
- Ligature; Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between Haemorrhoidectomy by Ligasure and conventional surgery
Detailed description
Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture which may lead to some postoperative complications mostly pain, bleeding and wound infection which ultimately cause prolonged stay in hospital.
A number of surgeons believe that by avoiding vascular pedicle ligation the chances of secondary bleeding can be decreased .This stimulated the researchers to develop new techniques with a less severe course and faster recovery . Recent advances in instrumental technology including the bipolar electrothermal device, ultrasonic scalpel, and circular stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these instruments, the LigaSure vessel sealing system has been recently introduced as a tool conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast healing . .Thus this operation can be recommended as the ideal technique. Many trials were performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although an overall favorable trend exists toward LigaSure, conclusions are not univocal and definitive; this creates some uncertainty, also considering the increasing cost for this disposable device: thus it is essential to keep on experimenting to determine whenever an actual advantage exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Conventional haemorrhoidectomyConventional haemrrhoidectomy,Ferguson technique |
| Group B | Experimental | Procedure: ligasure haemroidectomyLigasure haemorrhoidectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with ages between 18 to 70 years with symptomatic grade III, or IV hemorrhoid who will be operated on at the Department of general Surgery, Assuit University Hospital
Key exclusion criteria (7 listed)
- age older than 70 years
- patients with Grade I and II haemorrhoids
- patients on anticoagulants
- patients with liver cirrhosis
- patients with the hematological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ligasure haemroidectomyIn ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided. | Procedure or surgery | Group B |
| Conventional haemorrhoidectomyAccording to the Ferguson technique * Manual anal sphincter stretching up to 4 fingers * Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex. * skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter. After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed. | Procedure or surgery | Group A |
Primary outcome
Post operative pain
Time frame: 1 month
pain will be evaluated with visual analogue scale
2 secondary outcomes
Intra operative blood loss
Time frame: 1 day
Wound healing
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing ligasure haemroidectomy and Conventional haemorrhoidectomy in people with Ligature; Hemorrhage, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdel Rhman Refaie Kamel (01097722233, Refaay120@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.