Symptom Control 1-year After Circular Stapler Anopexy or... | NCT00841620

Studies
Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids

NCT00841620

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

May 4, 2015Estimated

Enrollment

207Actual

Phase

Phase 4

Conditions

Hemorrhoids

Interventions

Haemorrhoidectomy a.m. Milligan
Stapled anopexy

Countries

Denmark

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

Apr 2015

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

Sep 1999

Primary Completion Date

Jan 2001Actual

Completion Date

Apr 2007Actual

First Submitted Date

Feb 10, 2009

First Submission Date that Met QC Criteria

Feb 10, 2009

First Posted Date

Feb 11, 2009Estimated

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 30, 2015

Last Update Posted Date

May 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Niels Qvist, Professor, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Name	Class
Karolinska University Hospital	OTHER
Oxford University Hospitals NHS Trust	OTHER

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

Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.

Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Haemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids	Procedure: Haemorrhoidectomy a.m. Milligan
2	Active Comparator	Stapled anopexy for grade 3-4 haemorrhoids	Procedure: Stapled anopexy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haemorrhoidectomy a.m. Milligan	Procedure	Surgery	1
Stapled anopexy

Measure	Description	Time Frame
Self-reported frequency of symptoms		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Grades III and IV haemorrhoids

Exclusion Criteria:

Previous operation for high anal fistula or injury to the anal sphincteres

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Niels Qvist, Professor		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense C		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids
D010149	Pain, Postoperative
D011183	Postoperative Complications

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