[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658292":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":24,"studyPopulation":24,"armGroups":42,"interventions":55,"overallOfficials":24,"centralContacts":65,"locations":71,"responsibleParty":89,"collaborators":24,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":24,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":24,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":24,"overallStatus":73,"whyStopped":24,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":24},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Postoperative anal function as assessed by Wexner Score","Scale Title: Wexner Fecal Incontinence Score. The minimum values:0. The maximum values:20. Higher scores mean a worse outcome.","At 3 and 6 months postoperatively",{"measure":14,"description":15,"timeFrame":16},"Postoperative quality of life as assessed by EORTC QLQ-C30","Scale Title: European Organization for Research and Treatment of cancer Quality of Life Questionnaire. The minimum values:0. The maximum values:100. Higher scores mean a worse outcome.","At 1 year postoperatively",{"measure":18,"description":19,"timeFrame":20},"3-year local recurrence rate as assessed by abdominal contrast-enhanced MRI","Participants have an MRI every 3 months postoperatively","3 years postoperatively",[22,26,29,33],{"measure":23,"description":24,"timeFrame":25},"Circumferential resection margin negative rate",null,"Immediately after the pathology results come out",{"measure":27,"description":24,"timeFrame":28},"intraoperative blood loss","Immediately after the surgery",{"measure":30,"description":31,"timeFrame":32},"Postoperative-related complication incidence","Complications include postoperative bleeding, abdominal cavity infection, thoracic cavity infection, urinary tract infection, etc.","From the end of surgery to 3 months postoperatively",{"measure":34,"description":24,"timeFrame":35},"Postoperative hospital stay duration","From the end of surgery to discharge",{"allocation":37,"interventionModel":38,"interventionModelDescription":24,"primaryPurpose":39,"observationalModel":24,"timePerspective":24,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":24,"whoMasked":24},"NONE",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"PPISR","EXPERIMENTAL","The experimental group underwent the PPISR procedure.",[48],"Procedure: Precision Partial Intersphincteric Resection (PPISR)",{"label":50,"type":51,"description":52,"interventionNames":53},"Traditional ISR","ACTIVE_COMPARATOR","The control group underwent the traditional ISR procedure",[54],"Procedure: Traditional Intersphincteric Resection",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":24},"PROCEDURE","Precision Partial Intersphincteric Resection (PPISR)","The experimental group underwent the PPISR procedure. The surgical process was as follows:\n\n1. The abdominal team performed the TME procedure, completely resecting the mesorectum at the level of the mesorectum termination line within the levator hiatus.\n2. The transanal team completed routine preoperative preparation and disinfection, and located the distal and lateral resection margins of the tumor (with a margin distance ≥5 mm from the tumor boundary), thereby preserving part of the internal anal sphincter and normal intestinal wall tissue.\n3. A \"U\"-shaped dissection was performed cranially along the marking line within the intersphincteric space, meeting the abdominal team at the level of the levator hiatus, as shown in Figure 1.\n4. The specimen was removed either transanally or transabdominally.\n5. The proximal intestinal segment was trimmed, intestinal anastomosis was performed manually, and the procedure was concluded.",[44],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":24},"Traditional Intersphincteric Resection","The control group underwent the traditional ISR procedure. The surgical process was as follows:\n\n1. The abdominal team entered the abdominal cavity and mobilized the sigmoid colon and rectum according to the principle of total mesorectal excision (TME). The vessels were ligated at a high position, and the rectum was dissected downward along the presacral space to the level of the levator ani muscle (pelvic floor), fully exposing the distal rectum and the levator ani muscle.\n2. The transanal team made a full-thickness circumferential incision in the rectal mucosa slightly above the dentate line (approximately ≥1 cm), entering the intersphincteric groove. A sharp circumferential dissection was performed along this groove to \"pull\" the rectum (along with its internal sphincter) out from within the external anal sphincter. During this dissection, care was taken to avoid damaging the external sphincter complex and its innervation.\n3. When the perineal dissection plane reached the level of",[50],[66],{"name":67,"role":68,"phone":69,"phoneExt":24,"email":70},"shaotang li","CONTACT","86+18815039766","lishaotang163@163.com",[72],{"facility":5,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Wenzhou","Zhejiang","325000","China","CN",{"type":80,"coordinates":81},"Point",[82,83],120.66682,27.99942,{"lat":83,"lon":82},[86],{"name":87,"role":68,"phone":88,"phoneExt":24,"email":24},"chunwu zhang","86+0577-55578055",{"type":90,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100658292","application-of-precision-partial-intersphincteric-resection-ppisr-100658292",false,"NCT07849023","Application of Precision Partial Intersphincteric Resection (PPISR)","Application of Precision Partial Intersphincteric Resection (PPISR) in Patients With Ultra-low Rectal Cancer","Inclusion Criteria:\n\n* Patients aged 18-75 years old\n* Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma\n* Tumor lower margin ≤ 5 cm from the anal verge\n* Pre-operative tumor (T) staging of T1-T3 and T1-T2 below the level of the anal raphe muscle\n* No distant metastasis such as lung, liver and other organs\n\nExclusion Criteria:\n\n* Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)\n* Patients with malignant tumors in other parts of the body\n* Patients who underwent emergency surgery due to acute perforation, obstruction, etc.\n* Patients with tumor infiltration of peripheral organs during the operation, which required combined resection or palliative resection\n* Patients who had a mid-opening laparoscopic operation for various reasons -during the operation\n* Patients with poor anal function before operation, which is not suitable for anus preservation surgery.","ALL","18 Years","75 Years",{"count":102,"type":103},100,"ESTIMATED","INTERVENTIONAL",[106],"NA","The goal of this study is to establish a standardized operating procedure for Precision Partial Intersphincteric Resection (PPISR), and to evaluate its surgical safety, functional benefits, and oncological efficacy.",[109,110],"Low Rectal Cancer","Rectal Cancer Patients","2026-09-29",{"date":113,"type":114},"2026-09-30","ACTUAL",{"date":116,"type":114},"2026-02-08",{"date":118,"type":103},"2030-06",{"name":5,"class":6},1]