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

NCT04950140 | Unknown FDA Device

• 1 other identifier: NP1465
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Robot Assisted Laparoscopic

EXPERIMENTAL

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

Procedure: Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia

Conventional Laparoscopic Surgery

ACTIVE COMPARATOR

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

Procedure: Laparoscopic Surgery for the Treatment of Parastomal Hernia

Interventions

Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia PROCEDURE

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

Robot Assisted Laparoscopic

Laparoscopic Surgery for the Treatment of Parastomal Hernia PROCEDURE

Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients

Conventional Laparoscopic Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ricardo Abdalla

CONTACT

+551121892646; ricardo.abdalla@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: July 24, 2021
• Primary Completion: September 24, 2021
• Study Completion: July 24, 2023
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share