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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04950140
Other study ID # NP1465
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 24, 2021
Est. completion date July 24, 2023

Study information

Verified date June 2021
Source Instituto do Cancer do Estado de São Paulo
Contact Ricardo Abdalla
Phone +551121892646
Email ricardo.abdalla@hc.fm.usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 24, 2023
Est. primary completion date September 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia
Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
Laparoscopic Surgery for the Treatment of Parastomal Hernia
Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto do Cancer do Estado de São Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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