Incisional HerniaIRISNCT05596357
Incisional heRnia dIgestion Sexuality
An observational study of Incisional Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- questionnaires
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2023to 1 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Adult, Older adult
Study population: patients operated on on the abdomen will present with an eventration (incisional hernia)
Who may be able to join
- Patients aged 18 to 79
- No opposition to research
- Planned surgery to cure a hernia or complex anterior eventration of the abdomen by laparotomy or laparoscopy
- Mastery of the French language sufficient to answer questionnaires
- Registration in a national health care system
Who cannot join
- Emergency surgery
- ASA (American Society of Anesthesiologists) score> 3 during the preoperative consultation
- Current pregnancy or breastfeeding
- Patient under guardianship or curatorship
- Patient under AME (State Medical Aid)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
David Moszkowicz
Colombes, Île-de-France Region, 92700
About this study
Official title: Observational Study of the Benefits of Complex Abdominal Wall Repairs on Quality of Life , Digestive and Sexual Functions.
After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients
Read the detailed description
Almost 20% of patients operated on the abdomen will present with an incisional hernia and each year in France, more than 50,000 patients are operated on for an eventration with placement of a parietal mesh.
These incisional hernia, corresponding to the permanent exteriorization of the abdominal viscera contained in a peritoneal sac through a scar muscle defect in the abdominal wall, are responsible for major anatomical and physiological alterations affecting the respiratory, cardiovascular and musculoskeletal systems.
Sometimes the hernia sac is so large that the viscera have lost their place in the abdomen . The presence of a large protrusion of the anterior abdomen alters the patient's center of gravity, affecting his ambulation and posture
Thus, surgical repair of the abdomen, indicated to correct chronic pain, functional limitation and cosmetic damage related to incisional hernia, helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of the patients. The consequent benefits on the quality of life and the reduction of chronic pain have been demonstrated by several studies, including a randomized trial [Rogmark, but certain aspects of the functional limitations linked to the presence of an eventration have never been studied (not published), as well as their specific impact on quality of life.
In fact, the daily experience of the management of these pathologies suggests that most patients with an abdominal wall problem, on the one hand, evoke difficulties to exonerate (abdominal pushing efforts are rendered ineffective due to the leakage of abdominal pressure in the incisional hernia sac, sometimes forcing patients to contain their stomachs by manual maneuvers or to wear an abdominal belt) and on the other hand difficulty having sexual intercourse (gene linked to the protrusion of abdomen, impaired body image and self-esteem).
Thus, a better knowledge of the actual digestive and sexual functional damage linked to these parietal pathologies, will make it possible to optimize the care of patients who will be better informed about their disease and the benefits they can expect from parietal repair (ease of having a bowel movement, improvement of sex life, benefits on quality of life).
- Conditions
- Incisional Hernia
- Being tested
- questionnaires
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
The patient must answer questionnaires before and after reconstructive surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Symtoms of constipation --> Patient Assessment of Constipation Symptoms (PAC-SYM)
Analyze changes in symptoms related to constipation before (1 month) and after surgical operation (M3, M12 and M24)
Measured: 25 months
Secondary outcomes (2)
Quality of life related to constipation -->Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Assessment of qualitiy of life related to constipation before (1 month) and after surgical operation (M3, M12 and M 24)
Measured: 25 months
Quality of life related to digestive function--> Gastrointestinal Quality of Life index (GIQLI)
Assessment of qualitiy of life related to digestive function before (1 month) and after surgical operation (M3, M12 and M 24)
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start10 Jul 2023
- Primary completion10 Jul 2023
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596357
- Sponsor's protocol ID
- 2021-A01003-38
- Acronym
- IRIS
- Status last verified
- Sep 2023
- First submitted
- 24 Oct 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Benefits of Complex Abdominal Wall Repairs on Quality of Life , Digestive and Sexual Functions.
- ClinicalTrials.gov ID
- NCT05596357
- Acronym / sponsor ID
- IRIS / 2021-A01003-38
- Conditions
- Incisional Hernia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients
Detailed description
Almost 20% of patients operated on the abdomen will present with an incisional hernia and each year in France, more than 50,000 patients are operated on for an eventration with placement of a parietal mesh.
These incisional hernia, corresponding to the permanent exteriorization of the abdominal viscera contained in a peritoneal sac through a scar muscle defect in the abdominal wall, are responsible for major anatomical and physiological alterations affecting the respiratory, cardiovascular and musculoskeletal systems.
Sometimes the hernia sac is so large that the viscera have lost their place in the abdomen . The presence of a large protrusion of the anterior abdomen alters the patient's center of gravity, affecting his ambulation and posture
Thus, surgical repair of the abdomen, indicated to correct chronic pain, functional limitation and cosmetic damage related to incisional hernia, helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of the patients. The consequent benefits on the quality of life and the reduction of chronic pain have been demonstrated by several studies, including a randomized trial [Rogmark, but certain aspects of the functional limitations linked to the presence of an eventration have never been studied (not published), as well as their specific impact on quality of life.
In fact, the daily experience of the management of these pathologies suggests that most patients with an abdominal wall problem, on the one hand, evoke difficulties to exonerate (abdominal pushing efforts are rendered ineffective due to the leakage of abdominal pressure in the incisional hernia sac, sometimes forcing patients to contain their stomachs by manual maneuvers or to wear an abdominal belt) and on the other hand difficulty having sexual intercourse (gene linked to the protrusion of abdomen, impaired body image and self-esteem).
Thus, a better knowledge of the actual digestive and sexual functional damage linked to these parietal pathologies, will make it possible to optimize the care of patients who will be better informed about their disease and the benefits they can expect from parietal repair (ease of having a bowel movement, improvement of sex life, benefits on quality of life).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients operated on on the abdomen will present with an eventration (incisional hernia)
Key inclusion criteria (5 listed)
- Patients aged 18 to 79
- No opposition to research
- Planned surgery to cure a hernia or complex anterior eventration of the abdomen by laparotomy or laparoscopy
- Mastery of the French language sufficient to answer questionnaires
Key exclusion criteria (5 listed)
- Emergency surgery
- ASA (American Society of Anesthesiologists) score> 3 during the preoperative consultation
- Current pregnancy or breastfeeding
- Patient under guardianship or curatorship
- Patient under AME (State Medical Aid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesThe patient must answer questionnaires before and after reconstructive surgery | Other | – |
Primary outcome
Symtoms of constipation --> Patient Assessment of Constipation Symptoms (PAC-SYM)
Time frame: 25 months
Analyze changes in symptoms related to constipation before (1 month) and after surgical operation (M3, M12 and M24)
2 secondary outcomes
Quality of life related to constipation -->Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Time frame: 25 months
Quality of life related to digestive function--> Gastrointestinal Quality of Life index (GIQLI)
Time frame: 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David MOSZKOWICZ, Pr (0033147606384, david.moszkowicz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symtoms of constipation --> Patient Assessment of Constipation Symptoms (PAC-SYM) (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.