NCT04950140

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parastomal Hernia
• Oncology

Interventions

Type	Name	Description
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
PROCEDURE	Laparoscopic Surgery for the Treatment of Parastomal Hernia	Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients

Timeline

• Start date: 2021-07-24
• Primary completion: 2021-09-24
• Completion: 2023-07-24
• First posted: 2021-07-06
• Last updated: 2021-07-06

Regulatory

• FDA-regulated device study