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

Hirschsprung Disease Clinical Trial

— RAMS vs LAMS  

Official title:

Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave With Short Muscular Cuff Anastomosis for Classical Hirschsprung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197061
• Other study ID #: robot Soave procedure
• Secondary ID: 82060100ZK-2021-
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: October 10, 2024

Study information

• Verified date: December 2023
• Source: Zunyi Medical College
• Contact: Ze bing prof. Zheng, M D
• Phone: 18285269257
• Email: zebing1988[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 10, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 1.Age no more than 18 years 2.Hirschsprung disease diagnosed by biopsy 3.Performed modified Soave procedure for treatment.

Exclusion Criteria:

• 1.Total colonic aganglionosis 2.Descending/transverse colon Hirschsprung disease 3.Combined with Down syndrome 4.preoperative enterostomy 5.refused to participate

Related Conditions & MeSH terms

• Hirschsprung Disease

Intervention

Procedure:
• RAMS
The robotic arms were oriented from the caudal direction. Dissection was begun circumferentially at 1.0 cm above the peritoneal reflection. The rectum was mobilized outside the longitudinal muscle layer, with the anatomical plane farther away from Denonvillier's fascia and the nerve plexus anterior or lateral to the rectum. The mobilization of the rectum reached 4-7 cm into the pelvis. After the robot was unlocked, a circular incision was made 0.5-1 cm from the dentate line, dividing the mucosa upward by 0.5-1.0 cm, breaking through the muscular cuff, and exposing the robotic dissection plane in the pelvis. The diseased colon was then gently pulled out through the anus. The posterior wall of the muscular cuff was completely removed along the left and right sides, accounting for two-thirds of the whole circular muscular cuff to 0.5 cm of the dentate line edge. One third of the anterior wall of the muscular cuff was retained,we then performed Soave's anastomosis.
• LAMS
The mesentery of the colon was separated by laparoscopy with the vessel of the pull-through bowel preserved. Under the rectal peritoneal reflex, close to the rectal wall separate with the electric hook, the anterior wall of the rectum was separated to the bladder neck or the posterior wall of the vagina. The posterior wall of the rectum can be separated down to 1cm above the dentate line. After the laparoscopy was unlocked, a circular incision was made 0.5-1 cm from the dentate line, dividing the mucosa upward by 0.5-1.0 cm, breaking through the muscular cuff, and exposing the laparoscopic dissection plane in the pelvis. The diseased colon was then gently pulled out through the anus. The posterior wall of the muscular cuff was completely removed along the left and right sides, accounting for two-thirds of the whole circular muscular cuff to 0.5 cm of the dentate line edge. One third of the anterior wall of the muscular cuff was retained,we then performed Soave's anastomosis.

Locations

Country	Name	City	State
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (4)

Crippa J, Grass F, Dozois EJ, Mathis KL, Merchea A, Colibaseanu DT, Kelley SR, Larson DW. Robotic Surgery for Rectal Cancer Provides Advantageous Outcomes Over Laparoscopic Approach: Results From a Large Retrospective Cohort. Ann Surg. 2021 Dec 1;274(6):e — View Citation

Miyano G, Koga H, Okawada M, Doi T, Sueyoshi R, Nakamura H, Seo S, Ochi T, Yamada S, Imaizumi T, Lane GJ, Okazaki T, Urao M, Yamataka A. Rectal mucosal dissection commencing directly on the anorectal line versus commencing above the dentate line in laparo — View Citation

Neuvonen MI, Kyrklund K, Rintala RJ, Pakarinen MP. Bowel Function and Quality of Life After Transanal Endorectal Pull-through for Hirschsprung Disease: Controlled Outcomes up to Adulthood. Ann Surg. 2017 Mar;265(3):622-629. doi: 10.1097/SLA.00000000000016 — View Citation

Zhang MX, Zhang X, Chang XP, Zeng JX, Bian HQ, Cao GQ, Li S, Chi SQ, Zhou Y, Rong LY, Wan L, Tang ST. Robotic-assisted proctosigmoidectomy for Hirschsprung's disease: A multicenter prospective study. World J Gastroenterol. 2023 Jun 21;29(23):3715-3732. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soiling	The incidence of complication of Soiling between two groups.	2 years
Primary	Enterocolitis	The incidence of complication of enterocolitis between two groups.	2 years
Secondary	operative time	The operative time(minute) were analysis in two groups	2 years
Secondary	The anal dissection time	The anal dissection time(minute) were analysis in two groups	2 years
Secondary	length of hospitalization	The postoperative length of hospitalization (days) were analysis between two groups	2 years
Secondary	blood loss	The Blood loss were analysis in two groups	2 years
Secondary	Perianal dermatitis	The incidence of complication of Perianal dermatitis between two groups	2 years
Secondary	Urinary incontinence	The incidence of complication of Urinary incontinence between two groups	2 years
Secondary	Anastomotic leakage	The incidence of complication of Anastomotic leakage between two groups	2 years
Secondary	Cuff abscess	The incidence of complication of Cuff abscess between two groups	2 years
Secondary	Anastomotic strictures	The incidence of complication of Anastomotic strictures between two groups	2 years
Secondary	Sphincter spasm	The incidence of complication of Sphincter spasm between two groups	2 years
Secondary	Staining	The incidence of complication of Staining between two groups	2 years
Secondary	Constipation	The incidence of complication of Constipation between two groups	2 years
Secondary	bowel function score (BFS)	Children aged = 4 years were assessed twice for each score. A BFS = 17 was represented as the lower limit of good/normal functional outcomes as more than 90% of people aged = 4 years in the normal population met this criterion	4 years
Secondary	postoperative fecal continence (POFC) score	postoperative fecal continence (POFC) score focused on SNS-related incontinence	4years