Role of Prosthetic Mesh in Preventing Parastomal Hernias

NCT01955278 | Unknown Phase 3 DMC

• 1 other identifier: HSCSP10070PPHP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parastomal Hernia

Keywords

Laparoscopic colorectal surgery; Parastomal hernia; Prophylactic; Mesh

Outcome Measures

Primary Outcomes (1)

• Compare the incidence of parastomal hernias between groups

  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

  During the monitoring period of one year

Secondary Outcomes (3)

• Compare the overall and specific postoperative morbidity and mortality between groups

  During the monitoring period of one year

• Compare the difference in surgical time between the conventional technique and the prosthetic mesh group

  During the surgery

• Compare hospital stay between the groups

  Patientes will be followed for the duration of hospital stay, an expected average of 14 days

Study Arms (1)

Creation of defitinive end colostomy

EXPERIMENTAL

Patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy

Device: Definitive end colostomy with mesh; Other: Conventional definitive end colostomy

Interventions

Definitive end colostomy with mesh DEVICE

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.

Also known as: synthetic prosthetic mesh, low weight type, Ultrapro, 15x15 cm

Creation of defitinive end colostomy

Conventional definitive end colostomy OTHER

Creation of defitinive end colostomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de Santa Creu i Sant Pau

Barcelona, 08040, Spain

RECRUITING

Related Publications (12)

• Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.

  PMID: 15613293 BACKGROUND

• Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.

  PMID: 19011935 BACKGROUND

• Gogenur I, Mortensen J, Harvald T, Rosenberg J, Fischer A. Prevention of parastomal hernia by placement of a polypropylene mesh at the primary operation. Dis Colon Rectum. 2006 Aug;49(8):1131-5. doi: 10.1007/s10350-006-0615-1.

  PMID: 16826330 BACKGROUND

• Helgstrand F, Gogenur I, Rosenberg J. Prevention of parastomal hernia by the placement of a mesh at the primary operation. Hernia. 2008 Dec;12(6):577-82. doi: 10.1007/s10029-008-0387-8. Epub 2008 Jun 4.

  PMID: 18523836 BACKGROUND

• Vijayasekar C, Marimuthu K, Jadhav V, Mathew G. Parastomal hernia: Is prevention better than cure? Use of preperitoneal polypropylene mesh at the time of stoma formation. Tech Coloproctol. 2008 Dec;12(4):309-13. doi: 10.1007/s10151-008-0441-7. Epub 2008 Nov 18.

  PMID: 19018469 BACKGROUND

• Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58.

  PMID: 19502871 BACKGROUND

• Berger D. Prevention of parastomal hernias by prophylactic use of a specially designed intraperitoneal onlay mesh (Dynamesh IPST). Hernia. 2008 Jun;12(3):243-6. doi: 10.1007/s10029-007-0318-0. Epub 2007 Dec 11.

  PMID: 18071839 BACKGROUND

• Moreno-Matias J, Serra-Aracil X, Darnell-Martin A, Bombardo-Junca J, Mora-Lopez L, Alcantara-Moral M, Rebasa P, Ayguavives-Garnica I, Navarro-Soto S. The prevalence of parastomal hernia after formation of an end colostomy. A new clinico-radiological classification. Colorectal Dis. 2009 Feb;11(2):173-7. doi: 10.1111/j.1463-1318.2008.01564.x. Epub 2008 May 3.

  PMID: 18462232 BACKGROUND

• Rubin MS, Schoetz DJ Jr, Matthews JB. Parastomal hernia. Is stoma relocation superior to fascial repair? Arch Surg. 1994 Apr;129(4):413-8; discussion 418-9. doi: 10.1001/archsurg.1994.01420280091011.

  PMID: 8154967 RESULT

• Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z.

  PMID: 15981038 RESULT

• Goligher JC. Surgery of the anus, rectum and colon. 5th ed. London: Bailliere-Tindall; 1985.

  RESULT

• Janson AR, Janes A, Israelsson LA. Laparoscopic stoma formation with a prophylactic prosthetic mesh. Hernia. 2010 Oct;14(5):495-8. doi: 10.1007/s10029-010-0673-0. Epub 2010 May 23.

  PMID: 20496156 RESULT

Study Officials

• Eduardo Targarona, MD

  Hospital de Santa Creu i Sant Pau, Barcelona, Spain

  STUDY DIRECTOR

Central Study Contacts

Ozlem Uyanik, MD

CONTACT

0034677840299; ouyanik@santpau.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: October 7, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

ES (1)