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Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy

Primary Purpose

Internal Hemorrhoids

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Stapled hemorrhoidopexy
Milligan Morgan
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Internal Hemorrhoids focused on measuring Hemorrhoids, Surgery, Hemorrhoidopexy, Milligan Morgan

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • third degree circular hemorrhoids
  • symptomatic
  • reducible

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Stapled hemorrhoidopexy

    Milligan Morgan

    Arm Description

    surgical procedure to treat hemorrhoids

    surgical procedure to treat hemorrhoids

    Outcomes

    Primary Outcome Measures

    Postoperative Pain

    Secondary Outcome Measures

    long-term recurrence rate
    Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years. Postoperative morbidity such as bleeding, wound infection, urinary retention, and itching and burning, and transient incontinence symptoms, and parameters such as length of hospital stay and operating time were evaluated

    Full Information

    First Posted
    February 5, 2012
    Last Updated
    February 11, 2012
    Sponsor
    Universitätsklinikum Hamburg-Eppendorf
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01533363
    Brief Title
    Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
    Official Title
    Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2000 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitätsklinikum Hamburg-Eppendorf

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available. In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Internal Hemorrhoids
    Keywords
    Hemorrhoids, Surgery, Hemorrhoidopexy, Milligan Morgan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stapled hemorrhoidopexy
    Arm Type
    Active Comparator
    Arm Description
    surgical procedure to treat hemorrhoids
    Arm Title
    Milligan Morgan
    Arm Type
    Active Comparator
    Arm Description
    surgical procedure to treat hemorrhoids
    Intervention Type
    Procedure
    Intervention Name(s)
    Stapled hemorrhoidopexy
    Other Intervention Name(s)
    Ethicon PPH 01
    Intervention Type
    Procedure
    Intervention Name(s)
    Milligan Morgan
    Primary Outcome Measure Information:
    Title
    Postoperative Pain
    Time Frame
    within the first 30 days after surgery
    Secondary Outcome Measure Information:
    Title
    long-term recurrence rate
    Description
    Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years. Postoperative morbidity such as bleeding, wound infection, urinary retention, and itching and burning, and transient incontinence symptoms, and parameters such as length of hospital stay and operating time were evaluated
    Time Frame
    up to 5 years after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: third degree circular hemorrhoids symptomatic reducible Exclusion Criteria: single third-degree hemorrhoids acute incarcerated hemorrhoids intercurrent acute anal fissure acute anal fistula prior hemorrhoidectomy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jakob R Izbicki, MD
    Organizational Affiliation
    Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15973098
    Citation
    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.
    Results Reference
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    Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy

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