Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474403
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-13
Brief Title:
Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabeckers Operation
Sponsor:
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Organization:
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Study Overview
Official Title:
The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabeckers Operation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTEPP
Brief Summary:
Abstract
Parastomal hernia is a frequent complication following stoma formation presenting a significant surgical challenge with high recurrence rates The present study explores the efficacy of the laparoscopic total extraperitoneal TEP approach in parastomal hernia repair conceived as a modification of the Sugabeckers operation This prospective work who analysis aims to evaluate the feasibility safety and recurrence rates associated with this minimally invasive technique
Methods
A comprehensive review of patients undergoing laparoscopic TEP parastomal hernia repair between 2024 and 2026 will be performed Patient demographics operative details intraoperative complications postoperative morbidity recovery times and hernia recurrence rates will be collate and analyze
Results
The study will include 30 patients with a median follow-up period of 1month firstly viewers point and 12 months second view point The all of parastomal hernias will associated with colostomies Early mobilization will achieve with most patients returning to their routine activities within 2 weeks
Discussion
We anticipate that the data will suggest the laparoscopic TEP technique for parastomal hernia repair is a viable alternative to traditional methods with a favorable safety profile The minimally invasive nature of the operation appears to facilitate enhanced recovery while maintaining low recurrence rates Compared to the original Sugarbaker operation where the mesh is placed intraperitoneally the extraperitoneal placement of the mesh in TEP repair minimizes the potential for adhesion formation and related complications Furthermore aesthetic outcomes and patient satisfaction reports indicate a positive outlook
Conclusion
The laparoscopic TEP approach for parastomal hernia repair offers a modification to the Sugarbaker operation with potential benefits including reduced operative morbidity faster recovery and potentially lower recurrence rates Extended follow-up and comparison with the traditional approach are warranted to conclusively establish the long-term outcomes of this technique This study contributes to the evolving surgical management of parastomal hernias advancing towards less invasive and more patient-centered treatment modalities
Parastomal hernia is a frequent complication following stoma formation presenting a significant surgical challenge with high recurrence rates The present study explores the efficacy of the laparoscopic total extraperitoneal TEP approach in parastomal hernia repair conceived as a modification of the Sugabeckers operation This prospective work who analysis aims to evaluate the feasibility safety and recurrence rates associated with this minimally invasive technique
Methods
A comprehensive review of patients undergoing laparoscopic TEP parastomal hernia repair between 2024 and 2026 will be performed Patient demographics operative details intraoperative complications postoperative morbidity recovery times and hernia recurrence rates will be collate and analyze
Results
The study will include 30 patients with a median follow-up period of 1month firstly viewers point and 12 months second view point The all of parastomal hernias will associated with colostomies Early mobilization will achieve with most patients returning to their routine activities within 2 weeks
Discussion
We anticipate that the data will suggest the laparoscopic TEP technique for parastomal hernia repair is a viable alternative to traditional methods with a favorable safety profile The minimally invasive nature of the operation appears to facilitate enhanced recovery while maintaining low recurrence rates Compared to the original Sugarbaker operation where the mesh is placed intraperitoneally the extraperitoneal placement of the mesh in TEP repair minimizes the potential for adhesion formation and related complications Furthermore aesthetic outcomes and patient satisfaction reports indicate a positive outlook
Conclusion
The laparoscopic TEP approach for parastomal hernia repair offers a modification to the Sugarbaker operation with potential benefits including reduced operative morbidity faster recovery and potentially lower recurrence rates Extended follow-up and comparison with the traditional approach are warranted to conclusively establish the long-term outcomes of this technique This study contributes to the evolving surgical management of parastomal hernias advancing towards less invasive and more patient-centered treatment modalities
Detailed Description:
Introduction
Parastomal herniation presents as a common complication following stomal surgeries creating significant morbidity and adversely impacting the quality of life for patients Traditional open surgical techniques including Sugabeckers operation offer variable success rates and potential complications This study proposes an adaptation utilizing a laparoscopic total extraperitoneal TEP approach tailored to enhance the original Sugabecker method while aiming to reduce the perioperative morbidity and recurrence rates associated with parastomal hernia repairs
Objective
The primary objective of this research is to investigate the laparoscopic TEP parastomal hernia repair as a modification of the Sugabeckers operation and to assess its outcomes in terms of feasibility safety and hernia recurrence rate
Brief Protocol Description
Eligible candidates who have developed parastomal hernias following stoma creation and consented to the study will undergo laparoscopic TEP repair The procedure involves an initial unilateral transrectal incision followed by the creation of an preperitoneal or retro-rectus space where a mesh is positioned to reinforce the abdominal wall and the stoma Also it will has was formed oblique hernia canal The operative and postoperative outcomes of these patients will be studied in comparison with control group treated with the traditional Sugabeckers operation
Scientific Hypothesis
The hypothesis underpinning this research is that a laparoscopic TEP approach to parastomal hernia repair modifying Sugabeckers procedure can provide more favorable outcomes for example less intraoperative trauma fewer bowel injuries due to adhesiolysis and fewer intestinal perforations Specifically it is expected that this minimally invasive method will result in a significant reduction in postoperative pain shorter hospital stays faster recovery decreased morbidity and lower hernia recurrence rates in comparison with the traditional Sugabeckers or Pauls operations
Expected Results
This study anticipates that the laparoscopic TEP repair will demonstrate
1 A safe and reproducible procedure adaptable to different hernia sizes and locations around stomas
2 Reduced immediate intra - and postoperative complications including infections and hematoma formation
3 Quicker patient mobilization and discharge times when compared with the open approach
4 A statistically significant reduction in parastomal hernia recurrence over a long-term follow-up when matched against controls who have undergone traditional Sugabeckers repair
5 High patient satisfaction scores and improved quality of life indicators due to the minimally invasive nature of the repair
In conclusion through a detailed analysis of perioperative outcomes long-term follow-up and comparative studies with traditional methods this research aims to establish the laparoscopic TEP approach as a superior modification to parastomal hernia repair upholding the tenets of enhanced recovery and patient-centered care
Parastomal herniation presents as a common complication following stomal surgeries creating significant morbidity and adversely impacting the quality of life for patients Traditional open surgical techniques including Sugabeckers operation offer variable success rates and potential complications This study proposes an adaptation utilizing a laparoscopic total extraperitoneal TEP approach tailored to enhance the original Sugabecker method while aiming to reduce the perioperative morbidity and recurrence rates associated with parastomal hernia repairs
Objective
The primary objective of this research is to investigate the laparoscopic TEP parastomal hernia repair as a modification of the Sugabeckers operation and to assess its outcomes in terms of feasibility safety and hernia recurrence rate
Brief Protocol Description
Eligible candidates who have developed parastomal hernias following stoma creation and consented to the study will undergo laparoscopic TEP repair The procedure involves an initial unilateral transrectal incision followed by the creation of an preperitoneal or retro-rectus space where a mesh is positioned to reinforce the abdominal wall and the stoma Also it will has was formed oblique hernia canal The operative and postoperative outcomes of these patients will be studied in comparison with control group treated with the traditional Sugabeckers operation
Scientific Hypothesis
The hypothesis underpinning this research is that a laparoscopic TEP approach to parastomal hernia repair modifying Sugabeckers procedure can provide more favorable outcomes for example less intraoperative trauma fewer bowel injuries due to adhesiolysis and fewer intestinal perforations Specifically it is expected that this minimally invasive method will result in a significant reduction in postoperative pain shorter hospital stays faster recovery decreased morbidity and lower hernia recurrence rates in comparison with the traditional Sugabeckers or Pauls operations
Expected Results
This study anticipates that the laparoscopic TEP repair will demonstrate
1 A safe and reproducible procedure adaptable to different hernia sizes and locations around stomas
2 Reduced immediate intra - and postoperative complications including infections and hematoma formation
3 Quicker patient mobilization and discharge times when compared with the open approach
4 A statistically significant reduction in parastomal hernia recurrence over a long-term follow-up when matched against controls who have undergone traditional Sugabeckers repair
5 High patient satisfaction scores and improved quality of life indicators due to the minimally invasive nature of the repair
In conclusion through a detailed analysis of perioperative outcomes long-term follow-up and comparative studies with traditional methods this research aims to establish the laparoscopic TEP approach as a superior modification to parastomal hernia repair upholding the tenets of enhanced recovery and patient-centered care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None