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

NCT ID: NCT04950140

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-24
• Study Completion Date: 2023-07-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot Assisted Laparoscopic

Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

Group Type: EXPERIMENTAL

Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia

Intervention Type: PROCEDURE

Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

Conventional Laparoscopic Surgery

Conventional Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

Group Type: ACTIVE_COMPARATOR

Laparoscopic Surgery for the Treatment of Parastomal Hernia

Intervention Type: PROCEDURE

Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients

Interventions

Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia

Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

Intervention Type: PROCEDURE

Laparoscopic Surgery for the Treatment of Parastomal Hernia

Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ricardo Abdalla

Role: CONTACT

ricardo.abdalla@hc.fm.usp.br

+551121892646

Other Identifiers

NP1465

Identifier Type: -

Identifier Source: org_study_id