Skip to main content
OpenTrials
Completed

NCT Number: NCT01413867

Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids

Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.

This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

III Degree Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept of Emergency and Organ transplantation

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • III degree Hemorrhoids
  • written informed consent
  • mental ability to understand the procedure

Exclusion criteria

  • Previous treatments for hemorrhoids or other proctological diseases
  • Fecal Incontinence
  • Chronic inflammatory bowel disease
  • Anal sphincter lesions
  • coagulative defects
  • obstructed defecation

Treatment and study plan

stapled hemorrhoidopexy

Procedure

stapled hemorrhoidopexy will be performed using the EEA stapler Covidien

Primary outcomes

  1. quantity of anorectal mucosa resected using two different circular staplers

    Time frame: 1 hour following the end of the operation

    The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared

Secondary outcomes

  1. Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers

    Time frame: 1 hour after each operation

    the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids

Sponsors and collaborators

Lead sponsor

Societa Italiana di Chirurgia ColoRettale

Network

Registry information

Official study title

Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial

Acronym: EEA/PPH2011

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2011
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.