Prolapsed HemorrhoidsNCT01097759
LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy
An observational study of Prolapsed Hemorrhoids, run by Kuwait Oil Company Ahmadi Hospital at 1 site in Kuwait.
Trial summary
This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolapsed Hemorrhoids
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- 1 siteKuwait
- Study dates
- Jan 2006to Jul 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 68 patients with symptomatic grade III or grade IV hemorrhoids entered the study.
Who may be able to join
- Adult (above 18 years)
- With prolapsed hemorrhoids (grades III or IV)
Who cannot join
- Complicated hemorrhoid
- Coexisting perianal disease
- Previous perianal surgery
- Unfit for general anesthesia
- Pregnancy
- History of bleeding tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial
This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.
Read the detailed description
The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.
- Conditions
- Prolapsed Hemorrhoids
- Being tested
- Surgery
- Keywords
- hemorrhoids, prolapsed, hemorrhoidectomy, Hemorrhoidopexy, LigaSure, Stapled
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler
| Study group | Role | What they receive |
|---|---|---|
| LigaSure | LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery) Receives: Procedure: Surgery | |
| Stapler | Circular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain
Postoperative pain was assessed using the visual analogue scale (VAS)
Measured: 12 months
Secondary outcomes (1)
Assessment of postoperative complications
Postoperative complications and their management were compared between both groups during the followup visits for 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJan 2006
- Primary completionJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapsed HemorrhoidsStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait Oil Company Ahmadi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Investigators
- Mahmoud F Sakr, MD, PhD, Principal investigator, Professor of Surgery, Faculty of Medicine, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097759
- Sponsor's protocol ID
- 58061302393
- Status last verified
- Jan 2006
- First submitted
- 1 Apr 2010
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01097759
- Acronym / sponsor ID
- 58061302393
- Conditions
- Prolapsed Hemorrhoids
- Keywords
- hemorrhoids, prolapsed, hemorrhoidectomy, Hemorrhoidopexy, LigaSure, Stapled
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Kuwait Oil Company Ahmadi HospitalUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Apr 2010 (estimated)
- 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.
This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.
Detailed description
The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LigaSure | – | Procedure: SurgeryLigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery) |
| Stapler | – | Procedure: SurgeryCircular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 68 patients with symptomatic grade III or grade IV hemorrhoids entered the study.
Key inclusion criteria (2 listed)
- Adult (above 18 years)
- With prolapsed hemorrhoids (grades III or IV)
Key exclusion criteria (6 listed)
- Complicated hemorrhoid
- Coexisting perianal disease
- Previous perianal surgery
- Unfit for general anesthesia
- Pregnancy
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 |
|---|---|---|
| SurgeryHemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler | Procedure or surgery | LigaSure, Stapler |
Primary outcome
Assessment of postoperative pain
Time frame: 12 months
Postoperative pain was assessed using the visual analogue scale (VAS)
1 secondary outcome
Assessment of postoperative complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
Related trials for Prolapsed Hemorrhoids
Enrolling by invitationObservational study
Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes
Hemorrhoid, Hemorrhoid Prolapse
RecruitingObservational study
Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
Hemorrhoid Bleeding, Hemorrhoids Prolapse
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.
Mahmoud F Sakr, MD, PhD principal investigator
Professor of Surgery, Faculty of Medicine, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapsed Hemorrhoids, run by Kuwait Oil Company Ahmadi Hospital at 1 site in Kuwait.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative pain (time frame: 12 months). 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 2 Apr 2010.