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
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