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
About this trial
This is an interventional treatment trial for Internal Hemorrhoids focused on measuring Hemorrhoids, Surgery, Hemorrhoidopexy, Milligan Morgan
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.
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
NCT ID
NCT01533363
First Posted
February 5, 2012
Last Updated
February 11, 2012
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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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