NCT01533363

Brief Summary

The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

7.2 years

First QC Date

February 5, 2012

Last Update Submit

February 11, 2012

Conditions

Internal Hemorrhoids

Keywords

HemorrhoidsSurgeryHemorrhoidopexyMilligan Morgan

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    within the first 30 days after surgery

Secondary Outcomes (1)

  • long-term recurrence rate

    up to 5 years after surgery

Study Arms (2)

Stapled hemorrhoidopexy

ACTIVE COMPARATOR

surgical procedure to treat hemorrhoids

Procedure: Stapled hemorrhoidopexy

Milligan Morgan

ACTIVE COMPARATOR

surgical procedure to treat hemorrhoids

Procedure: Milligan Morgan

Interventions

Stapled hemorrhoidopexyPROCEDURE
Also known as: Ethicon PPH 01
Stapled hemorrhoidopexy
Milligan MorganPROCEDURE
Milligan Morgan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • third degree circular hemorrhoids
  • symptomatic
  • reducible

You may not qualify if:

  • single third-degree hemorrhoids
  • acute incarcerated hemorrhoids
  • intercurrent acute anal fissure
  • acute anal fistula
  • prior hemorrhoidectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gravie JF, Lehur PA, Huten N, Papillon M, Fantoli M, Descottes B, Pessaux P, Arnaud JP. Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up. Ann Surg. 2005 Jul;242(1):29-35. doi: 10.1097/01.sla.0000169570.64579.31.

    PMID: 15973098BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jakob R Izbicki, MD

    Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Surgeon

Study Record Dates

First Submitted

February 5, 2012

First Posted

February 15, 2012

Study Start

July 1, 2000

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 15, 2012

Record last verified: 2012-02