Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419998
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2024-05-14
Brief Title:
Transanal Versus Laparoscopic-assisted Transanal Through in the Management of Hirschsprungs Disease
Sponsor:
Egyptian Biomedical Research Network
Organization:
Egyptian Biomedical Research Network
Study Overview
Official Title:
One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprungs Disease in Pediatric Age Group A Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through TAERPT and laparoscopic-assistance endorectal pull-through LAERPT in pediatric patients presented with Hirschsprungs Disease between 3 months and 18 years old
The main questions our study aims to answer are
Does post-operative continence differs between the two groups
Does post-operative constipation differs between the two groups
Does post-operative soiling differs between the two groups
Does post-operative enterocolitis differs between the two groups
Do post-operative complications differ between the two groups If there is a comparison group Researchers will compare between pure transanal endorectal pull-through TAERPT and laparoscopic-assistance endorectal pull-through LAERPT to see if there is a difference in post-operative continence constipation soiling enterocolitis or complications
Participants will be divided into two groups 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B
The main questions our study aims to answer are
Does post-operative continence differs between the two groups
Does post-operative constipation differs between the two groups
Does post-operative soiling differs between the two groups
Does post-operative enterocolitis differs between the two groups
Do post-operative complications differ between the two groups If there is a comparison group Researchers will compare between pure transanal endorectal pull-through TAERPT and laparoscopic-assistance endorectal pull-through LAERPT to see if there is a difference in post-operative continence constipation soiling enterocolitis or complications
Participants will be divided into two groups 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B
Detailed Description:
Introduction One-stage treatment of endorectal pull-through for Hirschsprungs disease could be approached through a complete transanal approach or with the assistance of laparoscopy Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through TAERPT and laparoscopic-assistance endorectal pull-through LAERPT Material methods This retrospective study included 70 pediatric patients presented with Hirschsprungs Disease to Elshatby University Hospital 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools time of tolerating oral feeding the duration of hospital stay and the development of any early postoperative complications Also the number of bowel habits constipation enterocolitis abdominal distension anastomotic stricture and continence were assessed
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