Incisional heRnia dIgestion Sexuality (IRIS)

September 6, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Ile De France
      • Colombes, Ile De France, France, 92700
        • Recruiting
        • David Moszkowicz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients operated on on the abdomen will present with an eventration (incisional hernia)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
25 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life related to constipation -->Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Time Frame: 25 months
Assessment of qualitiy of life related to constipation before (1 month) and after surgical operation (M3, M12 and M 24)
25 months
Quality of life related to digestive function--> Gastrointestinal Quality of Life index (GIQLI)
Time Frame: 25 months
Assessment of qualitiy of life related to digestive function before (1 month) and after surgical operation (M3, M12 and M 24)
25 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of sexual function -->Femal Sexual Function Index (FSFI) and Male Sexual Health Questionnaire (MHSQ).
Time Frame: 25 months
Analyze changes in sexual function before (1 month) and after surgical operation (M3 M12, M24)
25 months
Changes in quality of life analysis --> Medical Outcome Study Short Form 12 (SF12),
Time Frame: 25 months
Analyze changes in quality of life before (1 month) and after surgical operation (M3 M12, M24)
25 months
Clinical recurrence
Time Frame: 36 months
Assessment of clinical recurrence M1, M3, M6, M12, M24, M36 after surgical operation
36 months
Radiological recurrence
Time Frame: 24 months
Assessment of radiological recurrence at M24 after surgical operation
24 months
Death
Time Frame: 36 months
Assessment of the mortality up to M36 after surgical operation
36 months
Pain analysis--> Visual Analog Scale (VAS)
Time Frame: 36 months
Analyze postoperative pain: M1, M3, M6, M12, M24 and M36
36 months
Morbidity --> Sepsis on mesh, hematoma, seroma, reoperation for complication, removal of the parietal mesh.
Time Frame: 1 month
Assessment of morbidity after surgical operation
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-A01003-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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