跳至主要内容
临床试验/NCT05596357
NCT05596357招募中不适用

Observational Study of the Benefits of Complex Abdominal Wall Repairs on Quality of Life , Digestive and Sexual Functions.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Symtoms of constipation --> Patient Assessment of Constipation Symptoms (PAC-SYM)

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Symtoms of constipation --> Patient Assessment of Constipation Symptoms (PAC-SYM)

时间窗: 25 months

Analyze changes in symptoms related to constipation before (1 month) and after surgical operation (M3, M12 and M24)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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