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

III Degree Hemorrhoids Clinical Trial

— EEA/PPH2011  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413867
• Other study ID #: No sponsor
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2011
• Last updated: December 10, 2013
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee of the Azienda Ospedaliero-Universitaria Policlinico "Vittorio Emanuele"Catania, Italy
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• III Degree Hemorrhoids

Intervention

Procedure:
• stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
• stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery

Locations

Country	Name	City	State
Italy	Dept of Emergency and Organ transplantation	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantity of anorectal mucosa resected using two different circular staplers	The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared	1 hour following the end of the operation	No
Secondary	Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers	the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids	1 hour after each operation	Yes