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Parastomal Hernia clinical trials

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NCT ID: NCT06077318 Not yet recruiting - Parastomal Hernia Clinical Trials

Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia

Start date: October 20, 2023
Phase:
Study type: Observational

Parastomal hernia (PSH) is difficult to manage, with high rates of post-operative recurrence and complication. Keyhole and Sugarbaker are the most commonly used techniques in the surgical repair of the PSH. However, the efficacy and safety of the two surgical methods have not been adequately compared in the East Asian population. Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 will be included. Patient demographic data and postoperative outcomes will be retrospectively analyzed. The primary outcome measure is the recurrence rate at one year follow-up time.

NCT ID: NCT05514600 Terminated - Parastomal Hernia Clinical Trials

Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair

Start date: September 8, 2022
Phase: N/A
Study type: Interventional

Fascial closure was not originally a routine component of minimally invasive parastomal hernia repairs, but several recent advancements have made fascial closure more common in this context. These include barbed self-locking sutures that aid intracorporeal fascial closure under tension, and wristed instrumentation offered by the robotic platform when available. The investigator aims to characterize the clinical significance of closing the fascia adjacent to the stoma during a MIS parastomal hernia repair. The investigator hypothesizes that fascial closure will not have a significant impact on postoperative stoma specific quality of life but will reduce long-term recurrence.

NCT ID: NCT04966065 Terminated - Parastomal Hernia Clinical Trials

Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies

PHARAO
Start date: March 14, 2016
Phase:
Study type: Observational

Short Title: PHARAOH study: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH A NO HOLE MESH. Objectives: Evaluation of operative complications, colostomy function, Quality of Life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a ParietexTM Parastomal No Hole mesh. Principle Investigators: Prof. Dr. Frederik Berrevoet, University Hospital Ghent Dr. Filip Muysoms, AZ Maria Middelares Ghent Patient selection: Adult consecutive patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy. A logbook will be kept of adult patients undergoing a parastomal hernia repair in the participating centers during the study period that are not entered in the study, including the reason for non inclusion. A total of 100 patients will be included during 24 months or until the sample size has been reached. Exclusion criteria: previous repair of a parastomal hernia at the same site, emergency operations, open parastomal hernia repair, parastomal hernias at an ileostomy or an ileal conduit stoma, loop colostomies, patients under the age of 18 years, pregnant women, ASA score 4 or more, no informed consent of the patient, patients unable to complete the stoma Quality of Life assessment. Primary Endpoint: Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively. Secondary Endpoints: Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.

NCT ID: NCT04950140 Not yet recruiting - Oncology Clinical Trials

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

LAROPA
Start date: July 24, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04749329 Recruiting - Parastomal Hernia Clinical Trials

Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

NCT ID: NCT04440514 Recruiting - Parastomal Hernia Clinical Trials

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

ePauli
Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.

NCT ID: NCT04397783 Recruiting - Clinical trials for Colorectal Neoplasms

Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

LONGCROSS
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ". DESIGN: Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio. POPULATION: Patients undergoing colorectal cancer surgery a definitive end colostomy. OBJECTIVES: The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery. Secondary objectives are: 1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery. 2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. 4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale). DESCRIPTION OF THE INTERVENTION: An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia. DURATION OF THE STUDY: The expected duration of the study is 3 years. PATIENT FOLLOW UP TIME: The planned follow-up time is 2 years. EXPECTED RECRUITMENT TIME: 12 months.

NCT ID: NCT04311333 Recruiting - Parastomal Hernia Clinical Trials

Endostomal Three-dimensional Ultrasonography for Parastomal Hernia

CTULOP
Start date: September 27, 2016
Phase: N/A
Study type: Interventional

The intention is to examine the role of ultrasonographic examination inside intestinal stomas in diagnosing parastomal hernia. Patients with a stoma since at least one year back who are being scheduled for abdominal surgery will be examined for eligibility according to the selection criteria. Included patients will undergo routine clinical examination, endostomal ultrasonography and computerized tomography scan of the abdomen. Findings will be correlated to findings during surgery (gold standard). Values for sensitivity, specificity, predictive values and likelihood ratio will be calculated.

NCT ID: NCT04282473 Recruiting - Parastomal Hernia Clinical Trials

Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

RESEDAE
Start date: May 24, 2022
Phase:
Study type: Observational

This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

NCT ID: NCT04187235 Completed - Parastomal Hernia Clinical Trials

Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

Start date: January 1, 1997
Phase:
Study type: Observational

This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.