Clinical trial · Interventional
Virtual Ileostomy Versus Conventional Loop Ileostomy
Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: A Randomized Controlled Study
NCT05985252CI-TRIAL-00068728unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with ghost ileostomy versus conventional loop ileostomy after low anterior resection for rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diverting ileostomy | Procedure | — | UNRESOLVED |
| Virtual ileostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual ileostomy
- description
- Laparoscopic or robotic surgery with virtual ileostomy
- interventionNames
- Procedure: Virtual ileostomy
- type
- ACTIVE_COMPARATOR
- label
- Diverting ileostomy
- description
- Laparoscopic or robotic surgery with diverting ileostomy
- interventionNames
- Procedure: Diverting ileostomy
Primary outcomes (1)
- measure
- Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
- timeFrame
- An average of 1 year from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed low to intermediate level rectal cancer, with the lower margin of anastomosis \<10cm from the anus. * age ≥18 years and ≤80 years. * the surgical procedure is anterior rectal resection (LAR). * intraoperative virtual or conventional ileostomy was performed. Exclusion Criteria: * BMI \>30 kg/m². * ASA score \>3. * Patients with coexisting complete intestinal obstruction. * History of long-term use of immunosuppressive drugs or glucocorticoids. * Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2. Patients with a history of myocardial infarction or coronary artery surgery within 6 months prior to the procedure. * chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/min). Intraoperative combined multi-organ resection. * Combined cirrhosis of the liver. * Intraoperative findings of incomplete anastomosis and positive insufflation test.
References
Publications (11)
- BACKGROUNDDegiuli M, Elmore U, De Luca R, De Nardi P, Tomatis M, Biondi A, Persiani R, Solaini L, Rizzo G, Soriero D, Cianflocca D, Milone M, Turri G, Rega D, Delrio P, Pedrazzani C, De Palma GD, Borghi F, Scabini S, Coco C, Cavaliere D, Simone M, Rosati R, Reddavid R; collaborators from the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group. Risk factors for anastomotic leakage after anterior resection for rectal cancer (RALAR study): A nationwide retrospective study of the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group. Colorectal Dis. 2022 Mar;24(3):264-276. doi: 10.1111/codi.15997. Epub 2021 Dec 6. PMID 34816571
- BACKGROUNDZhao S, Zhang L, Gao F, Wu M, Zheng J, Bai L, Li F, Liu B, Pan Z, Liu J, Du K, Zhou X, Li C, Zhang A, Pu Z, Li Y, Feng B, Tong W. Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568. PMID 34613330
- BACKGROUNDChapman WC Jr, Subramanian M, Jayarajan S, Makhdoom B, Mutch MG, Hunt S, Silviera ML, Glasgow SC, Olsen MA, Wise PE. First, Do No Harm: Rethinking Routine Diversion in Sphincter-Preserving Rectal Cancer Resection. J Am Coll Surg. 2019 Apr;228(4):547-556.e8. doi: 10.1016/j.jamcollsurg.2018.12.012. Epub 2019 Jan 9. PMID 30639302
- BACKGROUNDKim JH, Kim S, Jung SH. Fecal diverting device for the substitution of defunctioning stoma: preliminary clinical study. Surg Endosc. 2019 Jan;33(1):333-340. doi: 10.1007/s00464-018-6389-4. Epub 2018 Aug 14. PMID 30109482
- BACKGROUNDTsujinaka S, Suzuki H, Miura T, Sato Y, Shibata C. Obstructive and secretory complications of diverting ileostomy. World J Gastroenterol. 2022 Dec 21;28(47):6732-6742. doi: 10.3748/wjg.v28.i47.6732. PMID 36620340
- BACKGROUNDMurken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2.