stapled hemorrhoidopexy
ProcedureOther names: Ethicon PPH 01
NCT Number: NCT01533363
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.
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Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Ethicon PPH 01
Time frame: within the first 30 days after surgery
Time frame: up to 5 years after surgery
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
Universitätsklinikum Hamburg-Eppendorf
Other
Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
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