LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy | NCT01097759

Studies
LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

NCT01097759

Sponsor

Kuwait Oil Company Ahmadi Hospital

Status

Completed

Last Update Posted

Apr 2, 2010Estimated

Enrollment

115Actual

Phase

Not provided

Conditions

Prolapsed Hemorrhoids

Interventions

Surgery

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2008Actual

First Submitted Date

Apr 1, 2010

First Submission Date that Met QC Criteria

Apr 1, 2010

First Posted Date

Apr 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2010

Last Update Posted Date

Apr 2, 2010Estimated

Name	Class
Netherlands: Ministry of Health, Welfare and Sports	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LigaSure		LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery)	Procedure: Surgery
Stapler		Circular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery	Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler	LigaSure Stapler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of postoperative pain	Postoperative pain was assessed using the visual analogue scale (VAS)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of postoperative complications	Postoperative complications and their management were compared between both groups during the followup visits for 12 months	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (above 18 years)
With prolapsed hemorrhoids (grades III or IV)

Exclusion Criteria:

Complicated hemorrhoid
Coexisting perianal disease
Previous perianal surgery
Unfit for general anesthesia
Pregnancy
History of bleeding tendency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 68 patients with symptomatic grade III or grade IV hemorrhoids entered the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud F Sakr, MD, PhD	Professor of Surgery, Faculty of Medicine, Alexandria University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmadi Hospital		Al Ahmadi	Al Ahmadi	61008	Kuwait

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided