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Completed

NCT Number: NCT01380860

Primary Prevention of Peristomial Hernias Via Parietal Prostheses

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.

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Key information

Conditions

Parastomal Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Besancon, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colostomy with mesh implantation

Procedure

Colostomy with mesh implantation

Simple colostomy

Procedure

Colostomy with no mesh implantation.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study

Acronym: GRECCAR 07

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2011
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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