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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01413867

Acronym

EEA/PPH2011

Enrollment

120

Registered

2011-08-10

Start date

2011-03-31

Completion date

2013-12-31

Last updated

2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

III Degree Hemorrhoids

Keywords

hemorrhoids, circular staplers, mucosal resection, hemostatic suture

Brief 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.

Interventions

PROCEDUREstapled hemorrhoidopexy

stapled hemorrhoidopexy will be performed using the EEA stapler Covidien

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
quantity of anorectal mucosa resected using two different circular staplers	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

Measure	Time frame	Description
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026