Primary Prevention of Peristomial Hernias Via Parietal Prostheses (GRECCAR 07)

• ClinicalTrials.gov Identifier: NCT01380860
• Recruitment Status: Completed
• First Posted: June 27, 2011
• Last Update Posted: August 4, 2020
• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nīmes

Study Description

Brief Summary:

The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

Condition or disease	Intervention/treatment	Phase
Parastomal Hernia	Procedure: Colostomy with mesh implantation; Procedure: Simple colostomy	Not Applicable

Detailed Description:

Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
• Study Start Date: November 2012
• Actual Primary Completion Date: October 20, 2016
• Actual Study Completion Date: October 20, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mesh; The patients allocated to this arm of the study will have mesh (Covidien France: mono filament polyester bidimensional knit) implanted in association with their colostomy.	Procedure: Colostomy with mesh implantation; Colostomy with mesh implantation
Active Comparator: No mesh; The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.	Procedure: Simple colostomy; Colostomy with no mesh implantation.

Outcome Measures

Primary Outcome Measures :

1. Presence/absence of a peristomal hernia [ Time Frame: 24 months ]
   The occurrence of peristomal hernias is determined in both groups every three months up until 24 months. The presence of absence of a hernia is detected by clinical exam, and at 24 months by an additional radiology exam. The primary outcome concerns rates at 24 months, primo-events only.

Secondary Outcome Measures :

1. Presence/absence of peristomal hernia [ Time Frame: 12 months ]
   The presence of absence of a hernia is detected by clinical exam.
2. Days of hospitalisation [ Time Frame: 1 month ]
   The number of days spent in the hospital after the surgical intervention.
3. Operating time (minutes) [ Time Frame: Day 1 ]
4. Estimation of blood loss during the operation (ml) [ Time Frame: Day 1 ]
5. Was stomal repair necessary for the patient? yes/no [ Time Frame: 24 months ]
6. Was relocation of the colostomy required? yes/no [ Time Frame: 24 months ]
7. Presence/absence of complications [ Time Frame: 24 months ]
   Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
8. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 24 months ]
   A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
9. Pain around the colostomy [ Time Frame: 24 months ]
   A visual analog scale is used to assess the patient's perception of pain around the stomy site.
10. Abdominal pain [ Time Frame: 24 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
11. Pain medication consumption [ Time Frame: 24 months ]
12. Number of colostomy leaks per day [ Time Frame: 24 months ]
13. Number of colostomy sac changes per day [ Time Frame: 24 months ]
14. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 24 months ]
15. Questionnaire Stoma-QOL [ Time Frame: 24 months ]
    Validated assessment of quality of life.
16. Exposition of the prothesis (mesh): yes/no [ Time Frame: 24 months ]
17. Questionnaire Stoma-QOL [ Time Frame: 12 months ]
    Validated assessment of quality of life.
18. Questionnaire Stoma-QOL [ Time Frame: 1 month ]
    Validated assessment of quality of life.
19. Presence/absence of peri-operative complications [ Time Frame: Day 1 ]
20. Pain around the colostomy [ Time Frame: Day 1 ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
21. Pain around the colostomy [ Time Frame: 1 month ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
22. Pain around the colostomy [ Time Frame: 3 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
23. Pain around the colostomy [ Time Frame: 6 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
24. Pain around the colostomy [ Time Frame: 9 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
25. Pain around the colostomy [ Time Frame: 12 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
26. Pain around the colostomy [ Time Frame: 15 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
27. Pain around the colostomy [ Time Frame: 18 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
28. Pain around the colostomy [ Time Frame: 21 months ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.
29. Abdominal pain [ Time Frame: Day 1 ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
30. Abdominal pain [ Time Frame: 1 month ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
31. Abdominal pain [ Time Frame: 3 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
32. Abdominal pain [ Time Frame: 6 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
33. Abdominal pain [ Time Frame: 9 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
34. Abdominal pain [ Time Frame: 12 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
35. Abdominal pain [ Time Frame: 15 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
36. Abdominal pain [ Time Frame: 18 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
37. Abdominal pain [ Time Frame: 21 months ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.
38. Presence/absence of peristomal hernia [ Time Frame: 1 month ]
    The presence of absence of a hernia is detected by clinical exam.
39. Presence/absence of peristomal hernia [ Time Frame: 3 months ]
    The presence of absence of a hernia is detected by clinical exam.
40. Presence/absence of peristomal hernia [ Time Frame: 6 months ]
    The presence of absence of a hernia is detected by clinical exam.
41. Presence/absence of peristomal hernia [ Time Frame: 9 months ]
    The presence of absence of a hernia is detected by clinical exam.
42. Presence/absence of peristomal hernia [ Time Frame: 15 months ]
    The presence of absence of a hernia is detected by clinical exam.
43. Presence/absence of peristomal hernia [ Time Frame: 18 months ]
    The presence of absence of a hernia is detected by clinical exam.
44. Presence/absence of peristomal hernia [ Time Frame: 21 months ]
    The presence of absence of a hernia is detected by clinical exam.
45. Presence/absence of complications [ Time Frame: 1 month ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
46. Presence/absence of complications [ Time Frame: 3 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
47. Presence/absence of complications [ Time Frame: 6 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
48. Presence/absence of complications [ Time Frame: 9 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
49. Presence/absence of complications [ Time Frame: 12 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
50. Presence/absence of complications [ Time Frame: 15 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
51. Presence/absence of complications [ Time Frame: 18 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
52. Presence/absence of complications [ Time Frame: 21 months ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
53. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: Day 1 ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
54. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 1 month ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
55. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 3 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
56. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 6 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
57. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 9 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
58. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 12 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
59. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 15 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
60. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 18 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
61. Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 21 months ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
62. Pain medication consumption [ Time Frame: Day 1 ]
63. Pain medication consumption [ Time Frame: 1 month ]
64. Pain medication consumption [ Time Frame: 3 months ]
65. Pain medication consumption [ Time Frame: 6 months ]
66. Pain medication consumption [ Time Frame: 9 months ]
67. Pain medication consumption [ Time Frame: 12 months ]
68. Pain medication consumption [ Time Frame: 15 months ]
69. Pain medication consumption [ Time Frame: 18 months ]
70. Pain medication consumption [ Time Frame: 21 months ]
71. Number of colostomy leaks per day [ Time Frame: Day 1 ]
72. Number of colostomy leaks per day [ Time Frame: 1 month ]
73. Number of colostomy leaks per day [ Time Frame: 3 months ]
74. Number of colostomy leaks per day [ Time Frame: 6 months ]
75. Number of colostomy leaks per day [ Time Frame: 9 months ]
76. Number of colostomy leaks per day [ Time Frame: 12 months ]
77. Number of colostomy leaks per day [ Time Frame: 18 months ]
78. Number of colostomy leaks per day [ Time Frame: 15 months ]
79. Number of colostomy leaks per day [ Time Frame: 21 months ]
80. Number of colostomy sac changes per day [ Time Frame: Day 1 ]
81. Number of colostomy sac changes per day [ Time Frame: 1 month ]
82. Number of colostomy sac changes per day [ Time Frame: 3 months ]
83. Number of colostomy sac changes per day [ Time Frame: 6 months ]
84. Number of colostomy sac changes per day [ Time Frame: 9 months ]
85. Number of colostomy sac changes per day [ Time Frame: 12 months ]
86. Number of colostomy sac changes per day [ Time Frame: 15 months ]
87. Number of colostomy sac changes per day [ Time Frame: 18 months ]
88. Number of colostomy sac changes per day [ Time Frame: 21 months ]
89. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: Day 1 ]
90. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 1 month ]
91. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 3 months ]
92. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 6 months ]
93. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 9 months ]
94. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 12 months ]
95. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 15 months ]
96. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 18 months ]
97. Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 21 months ]
98. Exposition of the prothesis (mesh): yes/no [ Time Frame: 1 month ]
99. Exposition of the prothesis (mesh): yes/no [ Time Frame: 3 months ]
100. Exposition of the prothesis (mesh): yes/no [ Time Frame: 6 months ]
101. Exposition of the prothesis (mesh): yes/no [ Time Frame: 9 months ]
102. Exposition of the prothesis (mesh): yes/no [ Time Frame: 12 months ]
103. Exposition of the prothesis (mesh): yes/no [ Time Frame: 15 months ]
104. Exposition of the prothesis (mesh): yes/no [ Time Frame: 18 months ]
105. Exposition of the prothesis (mesh): yes/no [ Time Frame: 21 months ]
106. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 1 month ]
107. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 3 months ]
108. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 6 months ]
109. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 9 months ]
110. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 12 months ]
111. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 15 months ]
112. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 18 months ]
113. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 21 months ]
114. Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 24 months ]
115. Ablation of the mesh: yes/no [ Time Frame: 1 month ]
116. Ablation of the mesh: yes/no [ Time Frame: 3 months ]
117. Ablation of the mesh: yes/no [ Time Frame: 6 months ]
118. Ablation of the mesh: yes/no [ Time Frame: 9 months ]
119. Ablation of the mesh: yes/no [ Time Frame: 12 months ]
120. Ablation of the mesh: yes/no [ Time Frame: 15 months ]
121. Ablation of the mesh: yes/no [ Time Frame: 18 months ]
122. Ablation of the mesh: yes/no [ Time Frame: 21 months ]
123. Ablation of the mesh: yes/no [ Time Frame: 24 months ]
124. Evaluation of colostomy healing by the clinician [ Time Frame: Day 1 ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
125. Evaluation of colostomy healing by the clinician [ Time Frame: 1 month ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
126. Evaluation of colostomy healing by the clinician [ Time Frame: 3 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
127. Evaluation of colostomy healing by the clinician [ Time Frame: 6 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
128. Evaluation of colostomy healing by the clinician [ Time Frame: 9 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
129. Evaluation of colostomy healing by the clinician [ Time Frame: 12 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
130. Evaluation of colostomy healing by the clinician [ Time Frame: 15 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
131. Evaluation of colostomy healing by the clinician [ Time Frame: 18 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
132. Evaluation of colostomy healing by the clinician [ Time Frame: 21 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
133. Evaluation of colostomy healing by the clinician [ Time Frame: 24 months ]
     The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
134. Duration of postoperative fever (hours) [ Time Frame: 10 days ]
135. Presence/absence of postoperative fever > 37.2°C [ Time Frame: Day 1 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The patient has given informed consent
• The patient must be affiliated with a health insurance programme
• The patient must be available for 24 months of follow-up
• The patient requires a colostomy (primo-event, ie first colostomies only)

Exclusion Criteria:

• The patient is currently participating in another interventional study
• The patient is in an exclusion period determined by a previous study
• The patient is under guardianship
• The patient refuses to sign the consent
• It is impossible to communicate information to the patient (does not read French)
• The patient is pregnant
• The patient is breastfeeding
• There is a contra-indication for any treatment used in this study
• The subject has already had a colostomy
• The subject has peritonitis
• The subject needs a colostomy for infectious reasons

Contacts and Locations

Locations

France

CHRU de Besancon

Besancon, France, 25030

CHU de Bordeaux

Bordeaux, France, 33075

CHRU de Clermont Ferrand

Clermont Ferrand, France, 63058

APHP - Hôpital Beaujon

Clichy, France, 92110

Hôpital Albert Michallon, CHU de Grenoble

Grenoble, France, 38043

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin Bicêtre Cedex, France, 94275

CHRU de Lille - Hôpital Claude Huriez

Lille Cedex, France, 59037

Centre de Lutte Contre le Cancer - Centre Oscar Lambret

Lille, France, 59020

CHU de Lyon

Lyon, France, 69317

Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes

Marseille, France, 13009

APHM - Hôpital La Timone Adultes

Marseille, France, 13385

Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque

Montpellier, France, 34298

CHU de Nantes

Nantes, France, 44093

Centre Hospitalier Universitaire de Nîmes

Nîmes, France, 30029

APHP - Hôpital Saint-Antoine

Paris Cedex 12, France, 75571

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris Cedex 13, France, 75651

APHP - Hôpital Lariboisière

Paris, France, 75010

Hôpital Pontchailou

Rennes, France, 35033

CHU de Rouen

Rouen, France, 76038

Centre Régional de Lutte contre le Cancer Centre Paul Strauss

Strasbourg, France, 67065

CHU de Toulouse

Toulouse, France

CH de Vichy - Jacques Larin

Vichy, France, 03207

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Michel Prudhomme, MD, PhD; Centre Hospitalier Universitaire de Nîmes

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Prudhomme M, Rullier E, Lakkis Z, Cotte E, Panis Y, Meunier B, Rouanet P, Tuech JJ, Jafari M, Portier G, Dubois A, Sielezneff I, Parc Y, Faucheron JL, Meurette G, Lelong B, Piessen G, Karoui M, Fabbro-Peray P, Demattei C, Bertrand MM; GRECCAR research group. End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial. Ann Surg. 2021 Dec 1;274(6):928-934. doi: 10.1097/SLA.0000000000004371.

Prudhomme M, Alline M, Chauvat J, Fabbro-Perray P, Ripoche J, Bertrand MM; French Research Group of Rectal Cancer Surgery (GRECCAR). Primary prevention of peristomial hernias via parietal prostheses: A randomized, multicentric study (GRECCAR 7 trial). Dig Liver Dis. 2016 Jul;48(7):812-6. doi: 10.1016/j.dld.2016.03.020. Epub 2016 Apr 5.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01380860
• Other Study ID Numbers: PHRC-N/2011/MP-01; 2011-A01572-39 ( Other Identifier: RCB number )
• First Posted: June 27, 2011
• Last Update Posted: August 4, 2020
• Last Verified: August 2020

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

mesh; hernia

Additional relevant MeSH terms:

Hernia; Pathological Conditions, Anatomical