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Incisional Hernia clinical trials

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NCT ID: NCT05482139 Completed - Incisional Hernia Clinical Trials

Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'

Start date: January 1, 2004
Phase:
Study type: Observational

A retrospective review of all incisional hernia repairs at North Shore Hospital (NSH), Auckland, NZ was performed between January 2004 and July 2019. Patients who had an open or laparoscopic incisional hernia repair with mesh were included in this study. Patients were retrospectively followed up from the date of their operation until the end of the study period.

NCT ID: NCT05474677 Enrolling by invitation - Clinical trials for Suture Size, Incisional Hernia

The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Background: Incisional hernia is a common complication of midline laparotomy, and it is associated with high morbidity and high costs. Suture size used in the closure of the abdominal wall fascia was not studied independently. Objective: Identify the best suture size for closure of the fascia following laparotomy incisions, by assessing the suture size 2\0 versus zero. Research methods: Prospective, multicentric, randomized controlled and double-blind trial. Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. We aimed for a total of 276 patients (n=138 per group). The abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group. Patients will be followed for immediate post-operative wound complications and late complication after 6 months then after one year.

NCT ID: NCT05467124 Not yet recruiting - Hernia, Ventral Clinical Trials

Enhanced Recovery After Abdominal Wall Reconstruction

ERAWR
Start date: October 1, 2022
Phase:
Study type: Observational

The use of laparoscopy and the ERAS (Enhanced Recovery After Surgery) perioperative pathways are well defined in surgery and widely used worldwide. Predicting the success or failure of ERAS has become a matter of interest, as there is evidence confirming that greater compliance with the items of ERAS improves clinical outcomes. However, the impact that every single item of ERAS programs may have on postoperative recovery remains unknown. Furthermore, the loss of conformity, or deviation from the pathway, is multifactorial and derives from different issues (organizational, cultural, etc.). While data are available on the compliance of surgeons to ERAS pathways, it is impossible to establish which item is related to the benefits induced by ERAS. Regarding abdominal wall reconstruction (AWR) surgery, there is no uniform adherence to the ERAS protocol, often creating confusion about the effectiveness of the protocol itself. The goal of this multicenter, prospective, international, observational study is to prospectively assess adherence to the ERAS protocol in AWR surgery and its effectiveness in patients undergoing elective surgery for ventral primary/incisional hernias. The participating centers will consecutively enroll all patient candidates for an elective ventral or incisional hernia repair (open/laparoscopic/robotic/converted technique). The present study will include all patients ≥18 years old, capable of expressing valid informed consent, with a ventral/incisional hernia diagnosis confirmed by CT/US scan, who will undergo elective surgery. For each patient, anthropometric and personal data (sex, age, BMI) and data relating to their health state (ASA Score, previous abdominal surgery, hernia site) will be collected. Intraoperative data will include the type of surgery and intraoperative complications. Data regarding the adherence/lack of adherence to each item of the ERAS protocol will be collected, and, in the case of non-adherence, the reason will be specified, choosing between "habit", "disagreement", and "lack of organizational pathway", "other". During the post-operative period, all data regarding functional recovery will be recorded, i.e. the day of removal of the drainage, mobilization, return to bowel function, post-operative pain at first and third post-operative day and discharge, and length of hospitalization. Moreover, for each patient, data regarding post-operative complications will be collected and stratified by severity according to the Clavien-Dindo classification. This research is observational; therefore, no interventional changes should be made to the daily clinical practice at each participating center. Patients <18 years old, patients unable to provide valid informed consent, and those who refuse to be included in the study will be excluded. The study's primary objective is to evaluate adherence to the different items of the ERAS protocol for AWR surgery. The study's secondary objective is to evaluate which item of the protocol can affect the post-operative recovery of patients undergoing AWR surgery. The study's primary outcome is the compliance rate for each ERAS item for AWR surgery. The secondary outcomes of the study are the evaluation of complications, length of hospital stay, and recovery time after AWR in relation to compliance with the ERAS items. In addition, the study will evaluate: the time to removal of the drainage tube, if placed (post-operative day, n.), post-operative mobilization (hours, n.), time to resumption of post-operative liquid diet after surgery (hours, n.), time to resumption of liquid diet after surgery (hours, n.), pain at I-II-III post-operative day (VAS Score), time to return to bowel function (gas) (hours, n.), time to return to bowel function (stools) (hours, n.), length of hospital stay (days, n), pain at discharge (VAS Score), post-operative complications (n, within 30 days), type of complication (if any). The complications will be classified according to Clavien-Dindo: Grade I complication according to Clavien-Dindo. Statistical analyses will be performed with the SPSS 27 system (SPSS Inc., Chicago, IL, USA). Continuous data will be expressed as mean ± SD; categorical variables will be expressed as percentages. To compare continuous variables, an independent sample t-test will be implemented. The Wilcoxon Paired-Samples Test will be used as a non-parametric test similar to the paired-samples t-test used for continuous variables. The Chi-square test (or Fisher's exact test where appropriate) will be used to analyze categorical data. The results will be presented as 2-tailed values with statistical significance if p< 0.05. To adjust all other variables and make predictions, multivariate analyses will be performed with operative time or post-operative time or the occurrence of post-operative complications as dependent variables and with significant clinical and demographic characteristics as independent variables.

NCT ID: NCT05458310 Completed - Hernia Clinical Trials

The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries

Start date: January 1, 2018
Phase:
Study type: Observational

This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. The aim of this study is to determine the best site for specimen extrac/on with lowest risk of developing incisional hernia a0er laparoscopic colorectal surgeries.

NCT ID: NCT05439187 Completed - Clinical trials for Venous Thromboembolism

Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.

Start date: January 1, 2018
Phase:
Study type: Observational

Aim of our study is to find frequency and risk factors for venous thromboembolism development in patients who underwent surgery for incisional ventral hernia. There were 240 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2018 to December 2019. Compression duplex ultrasound of lower legs veins was performed in 2-4 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.

NCT ID: NCT05424484 Recruiting - Incisional Hernia Clinical Trials

Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence

MARS
Start date: November 10, 2022
Phase: N/A
Study type: Interventional

The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications. The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).

NCT ID: NCT05400083 Recruiting - Incisional Hernia Clinical Trials

Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)

PRINCESS
Start date: May 17, 2021
Phase:
Study type: Observational [Patient Registry]

Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia. This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .

NCT ID: NCT05384600 Completed - Incisional Hernia Clinical Trials

Incisional Hernia Prevention: Risk-benefit From a Patient's Perspective

INVITE
Start date: June 17, 2022
Phase:
Study type: Observational

Incisional Hernia (IH) is a common complication of abdominal surgery and causes serious morbidity to patients. IH formation is multifactorial and its risk varies from patient to patient. Risk-predictive tools have been developed to identify patients at high risk of IH before their initial operation, with high-risk patients possibly being offered the use of prophylactic mesh, placed at the end of the operation to prevent IH from forming. With controversy surrounding the use of mesh in other types of surgery, however, it is not known if mesh use is acceptable to patients. This study aims to assess how patients feel about prophylactic mesh and whether it is acceptable to them.

NCT ID: NCT05359510 Recruiting - Incisional Hernia Clinical Trials

The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing

Start date: April 26, 2022
Phase: N/A
Study type: Interventional

The use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.

NCT ID: NCT05351970 Completed - Clinical trials for Incisional Hernia of Midline of Abdomen

Barbed Suture for Emergency Midline Laparotomy Closure

BAROTOMY
Start date: January 1, 2021
Phase:
Study type: Observational

Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction. The aim of this study is to describe the incisional hernia rate after emergency midline laparotomy, according to the suture utilized, evaluated at one month and one year postoperative.