Role of Prosthetic Mesh in Preventing Parastomal Hernias (RPMPPH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
Ozlem Uyanik, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01955278
First received: September 11, 2013
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3).

Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8).

The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support.

Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro.

Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique.

Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period.

Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.


Condition Intervention Phase
Parastomal Hernia
Device: Definitive end colostomy with mesh
Other: Conventional definitive end colostomy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Study of the Role of Prosthetic Mesh in Preventing Parastomal Hernias in Patients With Definitive End Colostomy

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Compare the incidence of parastomal hernias between groups [ Time Frame: During the monitoring period of one year ] [ Designated as safety issue: Yes ]

    Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year.

    The expected result is the statistically significant reduction in the incidence of parastomal hernias in patients undergoing elective laparoscopy assisted colorectal surgery with realization of end colostomy reinforced with retromuscular mesh collocation



Secondary Outcome Measures:
  • Compare the overall and specific postoperative morbidity and mortality between groups [ Time Frame: During the monitoring period of one year ] [ Designated as safety issue: Yes ]
    Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year

  • Compare the difference in surgical time between the conventional technique and the prosthetic mesh group [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]
    The duration of the surgery will be compared bentween the groups

  • Compare hospital stay between the groups [ Time Frame: Patientes will be followed for the duration of hospital stay, an expected average of 14 days ] [ Designated as safety issue: Yes ]
    Days of hospital stay will be compared between the groups


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creation of defitinive end colostomy
Patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy
Device: Definitive end colostomy with mesh
In the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures.
Other Names:
  • synthetic prosthetic mesh
  • low weight type
  • Ultrapro
  • 15x15 cm
Other: Conventional definitive end colostomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with colorectal disease that require realization of definitive end colostomy
  • Laparoscopy assisted interventions
  • Interventions intended to radical treatment in case of oncologic pathology
  • Signed informed consent by the patient or representative in case of incapacity

Exclusion Criteria:

  • No acceptance to participate or inability to obtain signed informed consent
  • Urgent interventions
  • Palliative interventions
  • Lateral colostomies
  • American Society of Anesthesiologists (ASA) Classification IV-V
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955278

Contacts
Contact: Ozlem Uyanik, MD 0034677840299 ouyanik@santpau.cat

Locations
Spain
Hospital de Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08040
Contact: Ozlem Uyanik, MD    0034677840299    ouyanik@santpau.cat   
Principal Investigator: Ozlem Uyanik, MD         
Principal Investigator: Eduardo Targarona, MD         
Principal Investigator: Carmen Balague, MD         
Principal Investigator: Pilar Hernandez, MD         
Principal Investigator: Carmen Martinez, MD         
Principal Investigator: Jesus Bollo, MD         
Principal Investigator: Manuel Trias, MD         
Principal Investigator: Sorin Mocanu, MD         
Principal Investigator: Luis Pallares, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Study Director: Eduardo Targarona, MD Hospital de Santa Creu i Sant Pau, Barcelona, Spain
  More Information

Publications:

Responsible Party: Ozlem Uyanik, M.D., Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01955278     History of Changes
Other Study ID Numbers: HSCSP10070PPHP
Study First Received: September 11, 2013
Last Updated: September 28, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Laparoscopic colorectal surgery
Parastomal hernia
Prophylactic
Mesh

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014