[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619361":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":61,"collaborators":63,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Zunyi Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transanal Transection Duhamel Pull-Through for total colonic aganglionosis","EXPERIMENTAL","Arm A: Robot-Assisted Transanal Transection Duhamel (Modified Duhamel)\n\nProcedure: Robot-assisted or laparoscopic-assisted abdominal mobilization (as per center standard) plus transanal external transection Duhamel pull-through with retrorectal channel creation and side-to-side colorectal\u002Fcoloanal anastomosis according to a standardized operative protocol.\n\nPerioperative care: Standardized bowel preparation (if used), antibiotic prophylaxis, postoperative feeding pathway, and anal dilatation schedule per protocol.",[13],"Procedure: Transanal Transection Duhamel operation",{"label":15,"type":16,"description":17,"interventionNames":18},"Modified Soave Pull-Through for total colonic aganglionosis","ACTIVE_COMPARATOR","Arm B: Modified Soave Pull-Through\n\nProcedure: Minimally invasive (laparoscopic or robot-assisted per center capability) mobilization plus modified Soave endorectal pull-through with mucosectomy\u002Fcuff management according to a standardized operative protocol.\n\nPerioperative care: Same enhanced recovery and dilatation protocol framework.",[19],"Procedure: Modified Soave Pull-Through",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Transanal Transection Duhamel operation","The modified Duhamel procedure was performed using a transanal external rectal transection technique. Following mobilization of the ganglionated colon, the distal rectum was transected externally through the anal canal, expanding pelvic operative space and improving exposure compared with conventional pelvic transection. A retrorectal channel was created, and the colon was pulled through posterior to the native rectum. Residual rectal septum (spur) was eliminated using a transanal external compression technique, enabling a wide side-to-side colorectal or coloanal anastomosis. The anterior rectal wall was preserved, maintaining rectal sensory structures and avoiding circumferential endorectal dissection as used in Soave procedures. This approach was intended to optimize anastomotic configuration and postoperative bowel function.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Modified Soave Pull-Through","The modified Soave procedure was performed as a definitive pull-through following neonatal enterostomy. At approximately 1 year of age or older, patients underwent minimally invasive colectomy using a robotic-assisted or laparoscopic approach. The entire aganglionic colon was resected, and an endorectal pull-through was performed. The terminal ileum was delivered through the rectal cuff and anastomosed to the anal canal to restore intestinal continuity. This technique eliminates the aganglionic colorectal segment and avoids creation of a retrorectal pouch. Perioperative management and postoperative care were standardized across participating centers according to the study protocol.",[15],[32],{"name":33,"affiliation":34,"role":35},"Saotao Tang, M.D","Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"zebing zheng, M.D","CONTACT","+86-19985120815","zebing1988@sina.com",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Affiliated Hospital of Zunyi Medical University","Zunyi","Guizhou","563000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],106.90722,27.68667,{"lat":54,"lon":53},[57],{"name":58,"role":39,"phone":59,"phoneExt":26,"email":60},"Zhu Jin, M.D","+852-28609433","915884700@qq.com",{"type":35,"investigatorFullName":62,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Zebing Zheng",[64,65,67,69,72],{"name":34,"class":6},{"name":66,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":68,"class":6},"Shenzhen Maternity & Child Healthcare Hospital",{"name":70,"class":71},"The Affiliated Hospital of Binzhou Medical College","UNKNOWN",{"name":73,"class":6},"Guizhou Provincial People's Hospital","100619361","robotlaparoscopic-assisted-transanal-transection-duhamel-versus-modified-soave-pull-through-for-tca-100619361",false,"NCT07343622","Robot\u002FLaparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for TCA","Robot\u002FLaparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for Total Colonic Hirschsprung Disease: A Multicenter Controlled Trial","Inclusion Criteria:\n\n1. Definitive diagnosis of total colonic Hirschsprung disease confirmed by pathology from biopsy at neonatal enterostomy, consistent with total colonic aganglionosis.\n2. Two-stage surgical strategy: neonatal enterostomy performed first, followed by definitive pull-through as a second-stage procedure.\n3. Planned definitive reconstruction by one of the following techniques:\n4. Robot-assisted transanal transection Duhamel, orModified Soave pull-through (minimally invasive abdominal phase allowed).\n5. Availability for follow-up assessments and outcomes collection per protocol.\n\nExclusion Criteria:\n\n1. Trisomy 21 (Down syndrome).\n2. Definitive surgery performed by open laparotomy approach or Swenson procedure.\n3. One-stage primary pull-through without neonatal enterostomy (single-stage definitive management).","ALL","1 Month","14 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"NA","Total colonic Hirschsprung disease (TCA) is the most severe form of Hirschsprung disease and is commonly managed with neonatal enterostomy followed by delayed definitive pull-through. Despite widespread use, the optimal reconstructive procedure for TCA remains uncertain. The Duhamel and modified Soave pull-through procedures are the two most frequently adopted techniques, each with distinct theoretical advantages and limitations regarding bowel function, enterocolitis risk, and anorectal physiology. With the increasing application of minimally invasive and robot-assisted surgery, both procedures have been further refined; however, robust comparative evidence, particularly for total colonic disease, is lacking. To date, no multicenter study has provided a detailed comparison of postoperative functional outcomes and Hirschsprung-associated enterocolitis between transanal transection Duhamel and modified Soave procedures. This multicenter study compares robot-assisted transanal transection Duhamel and modified Soave pull-through in patients with pathologically confirmed TCA after neonatal enterostomy, focusing on postoperative bowel function and enterocolitis incidence.",[92,93,94,95],"Total Colonic Aganglionosis","Hirschsprung Disease","Duhamel","Soave",[97,98,99,100,101],"Robotic surgery","total colonic aganglionosis","modified Duhamel procedure","modified Soave procedure","Hirschsprung disease","NOT_YET_RECRUITING","2026-01-14",{"date":105,"type":106},"2026-01-15","ACTUAL",{"date":108,"type":86},"2026-01-30",{"date":110,"type":86},"2027-12-31",{"name":5,"class":6},1]