Parastomal Hernia Clinical Trial
Official title:
Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion: A Randomized Controlled Trial
The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a randomized controlled fashion.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 2019 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Ability to give informed consent. 2. Patients with history of chronic liver disease 3. Patients with history of systemic chemotherapy, radiotherapy or maintenance on systemic corticosteroids 4. Patients with chronic causes of increased intra-abdominal pressure as chronic cough (COPD) or chronic constipation 5. Patients with surgical history of hernia repair 6. Patients with body mass index (BMI) more than 30 kg/m2 7. Patients with other hernias (inguinal, umbilical or incisional) at preoperative evaluation 8. Patients with low serum albumin < 3 gm/dl 9. Patients who will be highly candidates for adjuvant or palliative chemo-radiotherapy such those with histopathologically proved residual tumor Exclusion Criteria: 1. Inability to give informed consent. 2. Patients who documented previous allergic reaction to synthetic mesh. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura | DK |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of parastomal hernia 2 years after surgery | The primary outcome of this study will be the incidence of parastomal hernia at 2 years after surgery | 2 years | |
Secondary | Adverse events related to mesh placement | The secondary outcome will be the adverse events related to mesh placement. | 2 years | |
Secondary | Health related quality of life as measured by Body Image Scale (BIS) questionnaire | Health related quality of life issues will be assessed also in both groups. | 2 years |
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