Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-27 @ 9:58 PM
Study NCT ID:
NCT06197061
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave Procedure for Classical Hirschsprung Disease
Sponsor:
Zunyi Medical College
Organization:
Study Overview
Official Title:
Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave With Short Muscular Cuff Anastomosis for Classical Hirschsprung Disease
Status:
RECRUITING
Status Verified Date:
2023-12
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:
RAMS vs LAMS
Brief Summary:
Hirschsprung disease (HSCR) is a rare congenital intestinal disease characterized by the absence of ganglion cells in the distal rectum, extending for variable distances into the proximal intestine.The \"pull-through\" reconstruction procedure described in 1949 by Orvar Swenson involving the removal of the aganglionic bowel and creating an anastomosis between the normally innervated bowel and the anal canal, remains the standard surgical approach for HSCR today. However, as rectal dissection by laparotomy in infants is technically difficult and can result in high rates of complications, other pull-through techniques were developed and several techniques are still widely used today.
In our institute, we developed the laparoscopic-assisted modified Soave with short muscular cuff anastomosis in July 2017, and achieved good therapeutic effects. However, there have some patients suffered soiling incidents in the short period post-surgery.
Therefore, we developed the robot-assisted modified Soave with short muscular cuff anastomosis procedures to protect the vital nerve and blood vessels of the pelvis from injury, decrease the injury of the sphincter.
this clinical trials was to compare the efficacy of robot-assisted and laparoscopic-assisted modified Soave with short muscular cuff anastomosis procedures for classical Hirschsprung disease (HSCR).
In our institute, we developed the laparoscopic-assisted modified Soave with short muscular cuff anastomosis in July 2017, and achieved good therapeutic effects. However, there have some patients suffered soiling incidents in the short period post-surgery.
Therefore, we developed the robot-assisted modified Soave with short muscular cuff anastomosis procedures to protect the vital nerve and blood vessels of the pelvis from injury, decrease the injury of the sphincter.
this clinical trials was to compare the efficacy of robot-assisted and laparoscopic-assisted modified Soave with short muscular cuff anastomosis procedures for classical Hirschsprung disease (HSCR).
Detailed Description:
Soave's first report on the endorectal pull-through without anastomosis approach to the treatment of Hirschsprung disease (HSCR) dates back to 1963. With the rapid development of laparoscopic operations in the early 1990s, Georgeson et al reported a technique utilizing laparoscopic dissection of the rectum combined with anal mucosal dissection in 1995. Subsequently, many laparoscopic approaches to modified Soave-Georgeson procedures were described, including short muscular cuff anastomosis, long cuff dissection, and short V-shaped partially resected cuff anastomosis.The purpose of these modifications is to decrease postoperative complications due to internal anal sphincter achalasia and rectal cuff.
Wester et al used a short cuff operation that retained a muscular cuff of 1-2 cm and achieved excellent outcomes. Due to our increased experience to Soave-Georgeson operation, we have modified the Soave-Georgeson procedure that developed laparoscopic stepwise gradient cutting muscular cuff procedure and shortened the muscular cuff to approximately 1-2 cm in neonates and infants, or 3-4 cm in children. Good results using the laparoscopic stepwise gradient cutting muscular cuff (LSGC) procedure have been reported by Zheng et al.
Although a few patients suffered enterocolitis of the LSGC procedure, we found that the incidence of enterocolitis in patients with a 1-2cm muscular cuff was lower than that in patients with a 3-4 cm muscular cuff. According to the above finding, we developed the laparoscopic-assisted modified Soave with short muscular cuff anastomosis in July 2017, and achieved good therapeutic effects. However, there have some patients suffered soiling incidents in the short period post-surgery.
Therefore, we developed the robot-assisted modified Soave with short muscular cuff anastomosis procedures to protect the vital nerve and blood vessels of the pelvis from injury, decrease the injury of the sphincter.
this clinical trials was to compare the efficacy of robot-assisted and laparoscopic-assisted modified Soave with short muscular cuff anastomosis procedures for classical Hirschsprung disease (HSCR).
Wester et al used a short cuff operation that retained a muscular cuff of 1-2 cm and achieved excellent outcomes. Due to our increased experience to Soave-Georgeson operation, we have modified the Soave-Georgeson procedure that developed laparoscopic stepwise gradient cutting muscular cuff procedure and shortened the muscular cuff to approximately 1-2 cm in neonates and infants, or 3-4 cm in children. Good results using the laparoscopic stepwise gradient cutting muscular cuff (LSGC) procedure have been reported by Zheng et al.
Although a few patients suffered enterocolitis of the LSGC procedure, we found that the incidence of enterocolitis in patients with a 1-2cm muscular cuff was lower than that in patients with a 3-4 cm muscular cuff. According to the above finding, we developed the laparoscopic-assisted modified Soave with short muscular cuff anastomosis in July 2017, and achieved good therapeutic effects. However, there have some patients suffered soiling incidents in the short period post-surgery.
Therefore, we developed the robot-assisted modified Soave with short muscular cuff anastomosis procedures to protect the vital nerve and blood vessels of the pelvis from injury, decrease the injury of the sphincter.
this clinical trials was to compare the efficacy of robot-assisted and laparoscopic-assisted modified Soave with short muscular cuff anastomosis procedures for classical Hirschsprung disease (HSCR).
Study Oversight
Has Oversight DMC:
True
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?: