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| Name | Class |
|---|---|
| Germans Trias i Pujol Hospital | OTHER |
| Fundación Jimenez Diaz de Madrid | UNKNOWN |
| Hospital Universitario La Fe | OTHER |
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Incisional hernia is a common complication after midline laparotomy and may significantly impact quality of life, morbidity, and healthcare costs. Patients undergoing cytoreductive surgery for ovarian cancer are considered at increased risk due to extensive surgical procedures, nutritional status, and exposure to systemic treatments.
This prospective randomized clinical trial aims to evaluate whether prophylactic mesh placement during abdominal wall closure reduces the incidence of incisional hernia compared with conventional fascial closure in women undergoing cytoreductive surgery for ovarian cancer through a midline laparotomy. To control for the potential effect of negative pressure wound therapy (NPWT) on surgical site infection, participants will also be randomized to receive NPWT or standard wound dressing, resulting in four treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Mesh + Negative Pressure Wound Therapy | Experimental | Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and postoperative negative pressure wound therapy using a PICO dressing for 7 days. |
|
| Prophylactic Mesh without Negative Pressure Wound Therapy | Experimental | Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing. |
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| Conventional Closure + Negative Pressure Wound Therapy | Active Comparator | Participants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days. |
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| Conventional Closure without Negative Pressure Wound Therapy | Experimental | Participants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic Mesh Placement | Procedure | Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Incisional Hernia | Presence of an abdominal wall incisional hernia confirmed by computed tomography (CT scan) or by imaging performed after clinical suspicion during follow-up. | 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infection | Surgical site infection according to CDC criteria. | Within 30 days after surgery |
| Incidence of Incisional Hernia at Intermediate Time Points | Radiologically confirmed incisional hernia detected during routine follow-up imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Luis Sánchez Iglesias, MD PhD | Contact | +34 932746000 | 3217 | jlsanig@yahoo.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Negative Pressure Wound Therapy (NPWT) | Device | Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively. |
|
| Standard Fascial Closure | Procedure | Continuous closure of the abdominal fascia using slowly absorbable monofilament suture (PDS 2-0), single-layer closure without peritoneal closure, maintaining a suture-to-wound length ratio greater than 4:1 and employing the small-bites technique. |
|
| 3, 6, and 12 months after surgery |
| Risk Factors Associated With Incisional Hernia Development | Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence. | Up to 24 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |