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| Name | Class |
|---|---|
| Medical University of Gdansk | OTHER |
| Śmietański Hernia Center | UNKNOWN |
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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.
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 Participation is voluntary and can be withdrawn at any time without affecting clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Clinical Care | Other | No intervention is assigned by the research protocol. Clinical management is determined by clinicians and patients according to usual practice; the study collects patient-reported outcome measures longitudinally. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (WHOQOL-BREF) | Change from baseline in the WHOQOL-BREF domain scores and overall quality of life/health items in women with PPAWIS receiving routine care. | Baseline and 6 months after baseline (window 5-7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Function (FSFI) | Change from baseline in Female Sexual Function Index (FSFI) total score (and domains, if applicable). | Baseline and 6 months after baseline (window 5-7 months) |
| Change in Body Image (Body Image scale) |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 18-65 years with postpartum abdominal wall insufficiency syndrome (PPAWIS), evaluated and managed in routine clinical care at the study site. Participants are assessed using validated patient-reported outcome measures at baseline and during follow-up to characterize symptom burden and changes over time.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Halska | Contact | 607 870 690 | worldofsurge@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maciej Śmietański, Prof. | Śmietański Hernia Center, LUX MED Hospital in Gdańsk | Principal Investigator |
| Sylwia Jędrzejewska, MD, PhD | Polish Sexological Society | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35941642 | Background | Smietanski M, Smietanska IA, Zamkowski M. Post-partum abdominal wall insufficiency syndrome (PPAWIS): lessons learned from a single surgeon's experience based on 200 cases. BMC Surg. 2022 Aug 8;22(1):305. doi: 10.1186/s12893-022-01757-y. |
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De-identified individual participant data (IPD) underlying the results reported in publications will be shared, including baseline and follow-up patient-reported outcome measure scores and a limited set of key clinical and demographic variables necessary to reproduce analyses (e.g., age range, BMI category, time since last delivery, presence of relevant abdominal wall findings). Direct identifiers will not be shared. Data will be pseudonymized and assessed for re-identification risk prior to release.
Data will be shared for research purposes related to postpartum abdominal wall dysfunction and patient-reported outcomes, subject to approval of a qualified research proposal and execution of a data use agreement.
IPD will be made available beginning 6 months after publication of the primary results and will remain available for 5 years.
Access will be provided through controlled access. Requests must include a research proposal, analysis plan, and documentation of ethics approval (if applicable). Requests will be reviewed by the study steering group. Approved requestors will be required to sign a data use agreement specifying permitted uses, prohibiting re-identification attempts, and requiring secure data storage. Data will be shared in a de-identified format.
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| ID | Term |
|---|---|
| C567402 | Diastasis Recti And Weakness Of The Linea Alba |
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Change from baseline in validated body image questionnaire score (instrument as specified in the study protocol and local language version).
| Baseline and 6 months after baseline (window 5-7 months) |
| Sustained Change in Quality of Life (WHOQOL-BREF) | Change from baseline in WHOQOL-BREF at long-term follow-up. | Baseline and 12 months after baseline (window 11-13 months) |