View clinical trials related to Internal Hernia.
Filter by:This is a prospective observational study in people treated with peritoneal dialysis for kidney failure to investigate whether estimated intraperitoneal pressure (eIPP) is correlated with non-infectious PD-related complications in end-stage renal failure patients. It looks to understand how both peritoneal dialysis complications (including fluid leaks and hernias) along with gastrointestinal symptoms are associated with eIPP in people treated with PD.
Comparison between hernioplasty alone versus concomitant abdominoplasty with ventral hernia repair regarding efficacy and post-operative recurrence of hernia.
Ventral hernias form when there is a loss of integrity of the abdominal wall muscles. Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens. The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure (PFC) without use of component separation technique (CST) in ventral hernia surgical repair. BOTOX is an investigational drug being developed for the treatment of ventral hernias. In this dose escalation study, participants will be placed in 1 of 3 cohorts. Cohort 1 will be randomized to receive placebo or 1 of 2 BOTOX doses, after which time Cohort 2 will be randomized to receive placebo or 1 of 3 BOTOX doses. Participants in Cohort 3 will be randomized to receive placebo or 1 of 3 BOTOX doses. Adult participants undergoing open abdominal ventral hernia repair will be enrolled. Around 200 participants will be enrolled in the study at approximately 20 sites in the United States. Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will be followed for approximately 3 months after surgery and will receive a follow-up phone call 30 days (+/-) their last study visit. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.
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.
This trial will compare laparoscopic and robotic-assisted abdominal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.