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

NCT06197061 | Unknown DMC

• 3 other identifiers: robot Soave procedure82060100ZK-2021-361
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Hirschsprung Disease

Keywords

Hirschsprung disease; robotic surgery; modified Soave; muscular cuff; Postoperative complications; Efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• operative time

  2 years

• The anal dissection time

  2 years

• length of hospitalization

  2 years

• blood loss

  2 years

• Perianal dermatitis

  2 years

Study Arms (2)

Robot-assisted modified Soave group

EXPERIMENTAL

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

laparoscopic-assisted modified Soave group

ACTIVE COMPARATOR

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

Interventions

RAMS PROCEDURE

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.

Robot-assisted modified Soave group

LAMS PROCEDURE

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.

laparoscopic-assisted modified Soave group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zunyi Medical College: lead

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 26386879 RESULT

• 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.

  PMID: 28169931 RESULT

• 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.

  PMID: 32068552 RESULT

• 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.

  PMID: 37398887 RESULT

MeSH Terms

Conditions

Hirschsprung Disease; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ze bing prof. Zheng, M D

CONTACT

18285269257; zebing1988@sina.com

Zhu prof. Jin, M D

CONTACT

18311566177; 980941736@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: February 7, 2020
• Primary Completion: February 8, 2024
• Study Completion: October 10, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)