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Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave Procedure for Classical Hirschsprung Disease

NCT06197061 · Zunyi Medical College · Updated 9 Jan 2024

What is being tested
RAMS; LAMS
For
Hirschsprung Disease
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Up to 18 years. About 130 people. The full rules are on the registry page.
Where
China
When
Starts or started 7 Feb 2020, ends 10 Oct 2024. Registered 9 Jan 2024.
Results
None posted yet.

In the researchers' words

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).
ClinicalTrials.gov, NCT06197061

Sites

  • Affiliated Hospital of Zunyi Medical UniversityZunyi, Guizhou, China