Primary Prevention of Peristomial Hernias Via Parietal Prostheses

Parastomal Hernia Clinical Trial

— GRECCAR 07  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380860
• Other study ID #: PHRC-N/2011/MP-01
• Secondary ID: 2011-A01572-39
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: October 20, 2018

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 20, 2018
• Est. primary completion date: October 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Procedure:
• Colostomy with mesh implantation
Colostomy with mesh implantation
• Simple colostomy
Colostomy with no mesh implantation.

Locations

Country	Name	City	State
France	CHRU de Besancon	Besancon
France	CHU de Bordeaux	Bordeaux
France	CHRU de Clermont Ferrand	Clermont Ferrand
France	APHP - Hôpital Beaujon	Clichy
France	Hôpital Albert Michallon, CHU de Grenoble	Grenoble
France	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex
France	Centre de Lutte Contre le Cancer - Centre Oscar Lambret	Lille
France	CHRU de Lille - Hôpital Claude Huriez	Lille Cedex
France	CHU de Lyon	Lyon
France	APHM - Hôpital La Timone Adultes	Marseille
France	Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes	Marseille
France	Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque	Montpellier
France	CHU de Nantes	Nantes
France	Centre Hospitalier Universitaire de Nîmes	Nîmes
France	APHP - Hôpital Lariboisière	Paris
France	APHP - Hôpital Saint-Antoine	Paris Cedex 12
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris Cedex 13
France	Hôpital Pontchailou	Rennes
France	CHU de Rouen	Rouen
France	Centre Régional de Lutte contre le Cancer Centre Paul Strauss	Strasbourg
France	CHU de Toulouse	Toulouse
France	CH de Vichy - Jacques Larin	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of a peristomal hernia	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.	24 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	12 months
Secondary	Days of hospitalisation	The number of days spent in the hospital after the surgical intervention.	1 month
Secondary	Operating time (minutes)		Day 1
Secondary	Estimation of blood loss during the operation (ml)		Day 1
Secondary	Was stomal repair necessary for the patient? yes/no		24 months
Secondary	Was relocation of the colostomy required? yes/no		24 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	24 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	24 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	24 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	24 months
Secondary	Pain medication consumption		24 months
Secondary	Number of colostomy leaks per day		24 months
Secondary	Number of colostomy sac changes per day		24 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		24 months
Secondary	Questionnaire Stoma-QOL	Validated assessment of quality of life.	24 months
Secondary	Exposition of the prothesis (mesh): yes/no		24 months
Secondary	Questionnaire Stoma-QOL	Validated assessment of quality of life.	12 months
Secondary	Questionnaire Stoma-QOL	Validated assessment of quality of life.	1 month
Secondary	Presence/absence of peri-operative complications		Day 1
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	Day 1
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	1 month
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	3 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	6 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	9 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	12 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	15 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	18 months
Secondary	Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	21 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	Day 1
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	1 month
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	3 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	6 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	9 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	12 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	15 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	18 months
Secondary	Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	21 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	1 month
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	3 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	6 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	9 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	15 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	18 months
Secondary	Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	21 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	1 month
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	3 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	6 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	9 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	12 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	15 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	18 months
Secondary	Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	21 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	Day 1
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	1 month
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	3 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	6 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	12 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	15 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	18 months
Secondary	Patient difficulty for fitting his/her colostomy with the appropriate sac.	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.	21 months
Secondary	Pain medication consumption		Day 1
Secondary	Pain medication consumption		1 month
Secondary	Pain medication consumption		3 months
Secondary	Pain medication consumption		6 months
Secondary	Pain medication consumption		9 months
Secondary	Pain medication consumption		12 months
Secondary	Pain medication consumption		15 months
Secondary	Pain medication consumption		18 months
Secondary	Pain medication consumption		21 months
Secondary	Number of colostomy leaks per day		Day 1
Secondary	Number of colostomy leaks per day		1 month
Secondary	Number of colostomy leaks per day		3 months
Secondary	Number of colostomy leaks per day		6 months
Secondary	Number of colostomy leaks per day		9 months
Secondary	Number of colostomy leaks per day		12 months
Secondary	Number of colostomy leaks per day		18 months
Secondary	Number of colostomy leaks per day		15 months
Secondary	Number of colostomy leaks per day		21 months
Secondary	Number of colostomy sac changes per day		Day 1
Secondary	Number of colostomy sac changes per day		1 month
Secondary	Number of colostomy sac changes per day		3 months
Secondary	Number of colostomy sac changes per day		6 months
Secondary	Number of colostomy sac changes per day		9 months
Secondary	Number of colostomy sac changes per day		12 months
Secondary	Number of colostomy sac changes per day		15 months
Secondary	Number of colostomy sac changes per day		18 months
Secondary	Number of colostomy sac changes per day		21 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		Day 1
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		1 month
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		3 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		6 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		9 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		12 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		15 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		18 months
Secondary	Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		21 months
Secondary	Exposition of the prothesis (mesh): yes/no		1 month
Secondary	Exposition of the prothesis (mesh): yes/no		3 months
Secondary	Exposition of the prothesis (mesh): yes/no		6 months
Secondary	Exposition of the prothesis (mesh): yes/no		9 months
Secondary	Exposition of the prothesis (mesh): yes/no		12 months
Secondary	Exposition of the prothesis (mesh): yes/no		15 months
Secondary	Exposition of the prothesis (mesh): yes/no		18 months
Secondary	Exposition of the prothesis (mesh): yes/no		21 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		1 month
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		3 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		6 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		9 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		12 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		15 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		18 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		21 months
Secondary	Presence/absence of a complication potentially linked to the presence of a mesh?		24 months
Secondary	Ablation of the mesh: yes/no		1 month
Secondary	Ablation of the mesh: yes/no		3 months
Secondary	Ablation of the mesh: yes/no		6 months
Secondary	Ablation of the mesh: yes/no		9 months
Secondary	Ablation of the mesh: yes/no		12 months
Secondary	Ablation of the mesh: yes/no		15 months
Secondary	Ablation of the mesh: yes/no		18 months
Secondary	Ablation of the mesh: yes/no		21 months
Secondary	Ablation of the mesh: yes/no		24 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	Day 1
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	1 month
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	3 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	6 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	9 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	12 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	15 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	18 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	21 months
Secondary	Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	24 months
Secondary	Duration of postoperative fever (hours)		10 days
Secondary	Presence/absence of postoperative fever > 37.2°C		Day 1