Incisional heRnia dIgestion Sexuality

NCT05596357 | Recruiting

• 1 other identifier: 2021-A01003-38
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life related to constipation -->Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)

  25 months

• Quality of life related to digestive function--> Gastrointestinal Quality of Life index (GIQLI)

  25 months

Other Outcomes (7)

• Analysis of sexual function -->Femal Sexual Function Index (FSFI) and Male Sexual Health Questionnaire (MHSQ).

  25 months

• Changes in quality of life analysis --> Medical Outcome Study Short Form 12 (SF12),

  25 months

• Clinical recurrence

  36 months

Interventions

questionnaires OTHER

The patient must answer questionnaires before and after reconstructive surgery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

David Moszkowicz

Colombes, Île-de-France Region, 92700, France

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

David MOSZKOWICZ, Pr

CONTACT

0033147606384; david.moszkowicz@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: July 10, 2023
• Primary Completion: July 10, 2023
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

FR (1)