Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave Procedure for Classical Hirschsprung Disease (RAMS vs LAMS)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hirschsprung Disease
• Intervention / Treatment: Procedure: RAMS; Procedure: LAMS

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).

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ze bing prof. Zheng, M D; Phone Number: 18285269257; Email: zebing1988@sina.com
• Study Contact Backup: Name: Zhu prof. Jin, M D; Phone Number: 18311566177; Email: 980941736@qq.com

Study Locations

• China
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Recruiting
      • Affiliated Hospital of Zunyi Medical University
      • Contact: Li Mei prof. Yu, MD; Phone Number: 19985120815; Email: zyfykyb@163.com
      • Principal Investigator: chengyan Dear.Tang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted modified Soave group; 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.	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.
Active Comparator: laparoscopic-assisted modified Soave group; 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 .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 with interrupted 5-0 or 4-0 absorbable sutures.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soiling	The incidence of complication of Soiling between two groups.	2 years
Enterocolitis	The incidence of complication of enterocolitis between two groups.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	The operative time(minute) were analysis in two groups	2 years
The anal dissection time	The anal dissection time(minute) were analysis in two groups	2 years
length of hospitalization	The postoperative length of hospitalization (days) were analysis between two groups	2 years
blood loss	The Blood loss were analysis in two groups	2 years
Perianal dermatitis	The incidence of complication of Perianal dermatitis between two groups	2 years
Urinary incontinence	The incidence of complication of Urinary incontinence between two groups	2 years
Anastomotic leakage	The incidence of complication of Anastomotic leakage between two groups	2 years
Cuff abscess	The incidence of complication of Cuff abscess between two groups	2 years
Anastomotic strictures	The incidence of complication of Anastomotic strictures between two groups	2 years
Sphincter spasm	The incidence of complication of Sphincter spasm between two groups	2 years
Staining	The incidence of complication of Staining between two groups	2 years
Constipation	The incidence of complication of Constipation between two groups	2 years
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
postoperative fecal continence (POFC) score	postoperative fecal continence (POFC) score focused on SNS-related incontinence	4years

Collaborators and Investigators

• Sponsor: Zunyi Medical College

Publications and helpful links

General Publications

• 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 laparoscopy-assisted transanal pull-through for Hirschsprung's disease: Prospective medium-term follow-up. J Pediatr Surg. 2015 Dec;50(12):2041-3. doi: 10.1016/j.jpedsurg.2015.08.022. Epub 2015 Aug 28.
• 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.0000000000001695.
• 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):e1218-e1222. doi: 10.1097/SLA.0000000000003805.
• 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. doi: 10.3748/wjg.v29.i23.3715.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Estimated): February 8, 2024
• Study Completion (Estimated): October 10, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Efficacy; Postoperative complications; robotic surgery; Hirschsprung disease; modified Soave; muscular cuff
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Digestive System Abnormalities; Megacolon; Hirschsprung Disease
• Other Study ID Numbers: robot Soave procedure; 82060100 (Other Grant/Funding Number: National Natural Science Foundation of China); ZK-2021-361 (Other Grant/Funding Number: Basic Research Project of Guizhou Province China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No