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

Oncology Clinical Trial

— LAROPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04950140
• Other study ID #: NP1465
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hernia
• Neoplasms
• Oncology
• Parastomal Hernia

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