Incisional heRnia dIgestion Sexuality (IRIS)

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: Recruiting
• Conditions: Incisional Hernia
• Intervention / Treatment: Other: questionnaires

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: David MOSZKOWICZ, Pr; Phone Number: 0033147606384; Email: david.moszkowicz@aphp.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	25 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of sexual function -->Femal Sexual Function Index (FSFI) and Male Sexual Health Questionnaire (MHSQ).	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),	Analyze changes in quality of life before (1 month) and after surgical operation (M3 M12, M24)	25 months
Clinical recurrence	Assessment of clinical recurrence M1, M3, M6, M12, M24, M36 after surgical operation	36 months
Radiological recurrence	Assessment of radiological recurrence at M24 after surgical operation	24 months
Death	Assessment of the mortality up to M36 after surgical operation	36 months
Pain analysis--> Visual Analog Scale (VAS)	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.	Assessment of morbidity after surgical operation	1 month

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID 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