Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

Study Overview
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Brief Summary
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Prospective randomized prospective interventional study with 40 consecutive patients for whom surgical treatment for PH was indicated and who are in postoperative follow-up with the Oncology Surgery group of the Department of Digestive Tract Surgery and Coloproctology, Faculty of Medicine, University of São Paulo . The free and informed consent form will be applied to the patient by the researchers in two copies of equal content and after any doubts related to the research are resolved, the patient will sign the copies together with the researcher. At any time, the patient may opt out of the study. The contacts of the researchers and the institution will be fully available to the research subject to resolve doubts and for any eventuality that may occur.

Official Title
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Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

Conditions
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Parastomal Hernia, Oncology

Intervention / Treatment
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* Procedure: Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia
* Procedure: Laparoscopic Surgery for the Treatment of Parastomal Hernia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PH in permanent ostomy, aged between 18 and 75 years, undergoing surgery for cancer treatment at ICESP, with stable cancer disease (recurrence or metastasis without evolution) or in follow-up after treatment with curative intent, who have computed tomography with a diagnosis of HP, and who agree to participate in the study. Exclusion Criteria: Patient with progressive cancer disease. Presence of disease that prevents the performance of videolaparoscopic surgical procedure such as severe heart failure, severe lung disease, etc. Clinical criteria according to the research team that may indicate the application of another specific technique that is not covered in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot Assisted Laparoscopic<br>Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient | Procedure: Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia<br>* Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient<br>|
| Active Comparator: Conventional Laparoscopic Surgery<br>Conventional Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient | Procedure: Laparoscopic Surgery for the Treatment of Parastomal Hernia<br>* Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh. |  | 1 year |