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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Asad Kutup, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01533363
First received: February 5, 2012
Last updated: February 11, 2012
Last verified: February 2012

February 5, 2012
February 11, 2012
July 2000
September 2007   (final data collection date for primary outcome measure)
Postoperative Pain [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01533363 on ClinicalTrials.gov Archive Site
long-term recurrence rate [ Time Frame: up to 5 years after surgery ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Internal Hemorrhoids
  • Procedure: Stapled hemorrhoidopexy
    Other Name: Ethicon PPH 01
  • Procedure: Milligan Morgan
  • Active Comparator: Stapled hemorrhoidopexy
    surgical procedure to treat hemorrhoids
    Intervention: Procedure: Stapled hemorrhoidopexy
  • Active Comparator: Milligan Morgan
    surgical procedure to treat hemorrhoids
    Intervention: Procedure: Milligan Morgan
Gravié 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01533363
1612
No
Dr. med. Asad Kutup, Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Study Chair: Jakob R Izbicki, MD Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg
Universitätsklinikum Hamburg-Eppendorf
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP