Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-24 @ 12:25 PM
Study NCT ID:
NCT06197061
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave Procedure for Classical Hirschsprung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006627', 'term': 'Hirschsprung Disease'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008531', 'term': 'Megacolon'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-25', 'studyFirstSubmitDate': '2023-12-25', 'studyFirstSubmitQcDate': '2023-12-25', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soiling', 'timeFrame': '2 years', 'description': 'The incidence of complication of Soiling between two groups.'}, {'measure': 'Enterocolitis', 'timeFrame': '2 years', 'description': 'The incidence of complication of enterocolitis between two groups.'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': '2 years', 'description': 'The operative time(minute) were analysis in two groups'}, {'measure': 'The anal dissection time', 'timeFrame': '2 years', 'description': 'The anal dissection time(minute) were analysis in two groups'}, {'measure': 'length of hospitalization', 'timeFrame': '2 years', 'description': 'The postoperative length of hospitalization (days) were analysis between two groups'}, {'measure': 'blood loss', 'timeFrame': '2 years', 'description': 'The Blood loss were analysis in two groups'}, {'measure': 'Perianal dermatitis', 'timeFrame': '2 years', 'description': 'The incidence of complication of Perianal dermatitis between two groups'}, {'measure': 'Urinary incontinence', 'timeFrame': '2 years', 'description': 'The incidence of complication of Urinary incontinence between two groups'}, {'measure': 'Anastomotic leakage', 'timeFrame': '2 years', 'description': 'The incidence of complication of Anastomotic leakage between two groups'}, {'measure': 'Cuff abscess', 'timeFrame': '2 years', 'description': 'The incidence of complication of Cuff abscess between two groups'}, {'measure': 'Anastomotic strictures', 'timeFrame': '2 years', 'description': 'The incidence of complication of Anastomotic strictures between two groups'}, {'measure': 'Sphincter spasm', 'timeFrame': '2 years', 'description': 'The incidence of complication of Sphincter spasm between two groups'}, {'measure': 'Staining', 'timeFrame': '2 years', 'description': 'The incidence of complication of Staining between two groups'}, {'measure': 'Constipation', 'timeFrame': '2 years', 'description': 'The incidence of complication of Constipation between two groups'}, {'measure': 'bowel function score (BFS)', 'timeFrame': '4 years', 'description': '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'}, {'measure': 'postoperative fecal continence (POFC) score', 'timeFrame': '4years', 'description': 'postoperative fecal continence (POFC) score focused on SNS-related incontinence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hirschsprung disease', 'robotic surgery', 'modified Soave', 'muscular cuff', 'Postoperative complications', 'Efficacy'], 'conditions': ['Hirschsprung Disease']}, 'referencesModule': {'references': [{'pmid': '26386879', 'type': 'RESULT', '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 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': '28169931', 'type': 'RESULT', '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.0000000000001695.'}, {'pmid': '32068552', 'type': 'RESULT', 'citation': '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': '37398887', 'type': 'RESULT', '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. doi: 10.3748/wjg.v29.i23.3715."}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nTherefore, 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.\n\nthis 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).', 'detailedDescription': "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.\n\nWester 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.\n\nAlthough 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.\n\nTherefore, 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.\n\nthis 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Age no more than 18 years 2.Hirschsprung disease diagnosed by biopsy 3.Performed modified Soave procedure for treatment.\n\nExclusion Criteria:\n\n* 1.Total colonic aganglionosis 2.Descending/transverse colon Hirschsprung disease 3.Combined with Down syndrome 4.preoperative enterostomy 5.refused to participate'}, 'identificationModule': {'nctId': 'NCT06197061', 'acronym': 'RAMS vs LAMS', 'briefTitle': 'Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave Procedure for Classical Hirschsprung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Zunyi Medical College'}, 'officialTitle': 'Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave With Short Muscular Cuff Anastomosis for Classical Hirschsprung Disease', 'orgStudyIdInfo': {'id': 'robot Soave procedure'}, 'secondaryIdInfos': [{'id': '82060100', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}, {'id': 'ZK-2021-361', 'type': 'OTHER_GRANT', 'domain': 'Basic Research Project of Guizhou Province China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-assisted modified Soave group', 'description': "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.", 'interventionNames': ['Procedure: RAMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic-assisted modified Soave group', 'description': "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.", 'interventionNames': ['Procedure: LAMS']}], 'interventions': [{'name': 'RAMS', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Robot-assisted modified Soave group']}, {'name': 'LAMS', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['laparoscopic-assisted modified Soave group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Mei prof. Yu, MD', 'role': 'CONTACT', 'email': 'zyfykyb@163.com', 'phone': '19985120815'}, {'name': 'chengyan Dear.Tang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}], 'centralContacts': [{'name': 'Ze bing prof. Zheng, M D', 'role': 'CONTACT', 'email': 'zebing1988@sina.com', 'phone': '18285269257'}, {'name': 'Zhu prof. Jin, M D', 'role': 'CONTACT', 'email': '980941736@qq.com', 'phone': '18311566177'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zunyi Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof', 'investigatorFullName': 'zebing Zheng', 'investigatorAffiliation': 'Zunyi Medical College'}}}}