Actively Recruiting
Observational Study of the Benefits of Complex Abdominal Wall Repairs on Quality of Life, Digestive and Sexual Functions
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-09-08
100
Participants Needed
1
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who develop an incisional hernia after abdominal surgery. This condition causes the abdominal organs to push through the scar tissue, which can lead to posture problems, pain, and reduced quality of life. The study aims to better understand the digestive and sexual difficulties linked to these hernias, as well as the benefits of surgical repair on these functions and overall well-being. Participants will undergo reconstructive surgery to repair the hernia, either through open surgery or laparoscopy. They will complete questionnaires before and after surgery to assess symptoms related to constipation, digestive function, and quality of life. The study focuses on how surgery may improve muscle tension, anatomical balance, and reduce functional limitations caused by the hernia. During the study, patients will answer questionnaires evaluating constipation symptoms and quality of life related to digestive and sexual functions over a period of up to 25 months. Researchers will use these assessments to measure the impact of surgery on patients' daily lives and functions. The study is observational and involves monitoring patients' experiences before and after their scheduled hernia repair surgery.
CONDITIONS
Brief Title
Incisional heRnia dIgestion Sexuality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Emergency surgery
- ASA (American Society of Anesthesiologists) score greater than 3 during preoperative consultation
- Current pregnancy or breastfeeding
- Patient under guardianship or curatorship
- Patient under AME (State Medical Aid)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo planned surgery to repair an incisional hernia or complex anterior eventration of the abdomen.
1 surgery visit and immediate post-operative assessment
Duration - Up to 25 months after surgery
Participants complete questionnaires before and after surgery to assess digestive function, constipation symptoms, and quality of life.
Multiple visits for questionnaire completion over 25 months
Trial Site Locations
Total: 1 location
1
David Moszkowicz
Colombes, Île-de-France Region, France, 92700
Actively Recruiting
Research Team
D
David MOSZKOWICZ, Pr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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