Incisional heRnia dIgestion Sexuality

ConditionIncisional Hernia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-79

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency surgery

ASA (American Society of Anesthesiologists) score> 3 during the preoperative consultation

Current pregnancy or breastfeeding

Patient under guardianship or curatorship

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

questionnaires
Other intervention
The patient must answer questionnaires before and after reconstructive surgery

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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)

Time frame

25 months

Secondary outcomes

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)

Time frame

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)

Time frame

25 months

Other outcomes

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)

Time frame

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)

Time frame

25 months

Clinical recurrence

Assessment of clinical recurrence M1, M3, M6, M12, M24, M36 after surgical operation

Time frame

36 months

Radiological recurrence

Assessment of radiological recurrence at M24 after surgical operation

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

Apply now