A Prospective Observational Cohort Study of Quality of Life, Body Image, and Sexual Function in Women With Postpartum Abdominal Wall Insufficiency Syndrome (PPAWIS) Using Patient-Reported Outcome Measures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Quality of Life (WHOQOL-BREF)
研究概览
简要总结
Postpartum abdominal wall insufficiency syndrome (PPAWIS) is a multidimensional condition that may affect physical function, quality of life, body image, and sexual health in women after childbirth. Anatomical findings alone do not fully explain symptom burden or patient experience.
This prospective observational cohort study will collect validated patient-reported outcome measures (PROMs) from women with PPAWIS receiving routine care. PROMs will be assessed at baseline and during follow-up to describe symptom burden and changes over time. The study aims to improve understanding of the patient-centered impact of PPAWIS and to support development of standardized assessment pathways in clinical practice.
详细描述
his is a prospective observational cohort study conducted in the setting of routine clinical care at Śmietański Hernia Center in Gdańsk (LUX MED Hospital) with collaboration from Medical University of Gdańsk. The study focuses on patient-centered outcomes in women with postpartum abdominal wall insufficiency syndrome (PPAWIS), a condition characterized by variable combinations of abdominal wall dysfunction and psychosocial impact after childbirth.
Participants will complete standardized, validated PROMs capturing quality of life, body image, and sexual function. Assessments will be performed at baseline (at/around qualification for routine care) and at predefined follow-up time points (e.g., 6 and 12 months). Clinical and demographic variables relevant for interpretation (e.g., time since last delivery, BMI, coexisting abdominal wall findings, and type of routine care received) will be recorded in a structured manner.
The study is non-interventional: treatment decisions and clinical management are determined by clinicians and patients according to usual practice and are not assigned by the research protocol. The primary purpose is to quantify baseline burden and describe longitudinal changes in PROMs, and to explore associations between patient-reported outcomes and selected clinical characteristics to inform future standardization of assessment and care pathways.
Data will be collected and stored using pseudonymized study identifiers. Participation is voluntary and can be withdrawn at any time without affecting clinical care.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 18-65 years
- •Postpartum status: at least 6 months after last delivery
- •Clinical diagnosis of postpartum abdominal wall insufficiency syndrome (PPAWIS), defined by abdominal wall dysfunction symptoms and/or significant quality-of-life impact, with supportive findings on physical examination and/or imaging (e.g., diastasis recti and/or related abdominal wall insufficiency features)
- •Receiving routine clinical care for PPAWIS at the study site (surgical)
- •Able and willing to provide informed consent and complete patient-reported outcome questionnaires at baseline and follow-up
排除标准
- •Current pregnancy
- •Planned pregnancy during the follow-up period (up to 12 months), if expected to interfere with outcome assessment
- •Inability to complete questionnaires due to cognitive impairment or insufficient language proficiency in the validated questionnaire language version
- •Severe uncontrolled psychiatric condition that, in the investigator's opinion, would prevent informed consent or reliable questionnaire completion
- •Participation in another interventional study that could materially affect patient-reported outcomes related to abdominal wall function during the follow-up period
研究组 & 干预措施
Women with PPAWIS (Routine Care)
Participants are women diagnosed with postpartum abdominal wall insufficiency syndrome (PPAWIS) receiving routine clinical care as determined by the treating clinicians and patient preferences. Management include surgical approaches according to usual practice. No intervention is assigned by the research protocol. Patient-reported outcome measures are collected at baseline and during follow-up.
干预措施: Routine Clinical Care (Other)
结局指标
主要结局
Change in Quality of Life (WHOQOL-BREF)
时间窗: Baseline and 6 months after baseline (window 5-7 months)
Change from baseline in the WHOQOL-BREF domain scores and overall quality of life/health items in women with PPAWIS receiving routine care.
次要结局
- Change in Sexual Function (FSFI)(Baseline and 6 months after baseline (window 5-7 months))
- Change in Body Image (Body Image scale)(Baseline and 6 months after baseline (window 5-7 months))
- Sustained Change in Quality of Life (WHOQOL-BREF)(Baseline and 12 months after baseline (window 11-13 months))