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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

NCT04950140 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-24
Primary Completion
2021-09-24
Completion
2023-07-24
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950140 on ClinicalTrials.gov