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

Instituto do Cancer do Estado de São Paulo

Status: Unknown

Conditions: Oncology; Parastomal Hernia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04950140

NP1465

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Robot Assisted Laparoscopic

Experimental group

Description:

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

Treatment:

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

Conventional Laparoscopic Surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic Surgery for the Treatment of Parastomal Hernia