Clinical trial · Interventional
No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer
Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study
NCT06225609CI-TRIAL-00073336not yet recruitingN/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 group versus no ileostomy group after total mesorectal excision 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 |
|---|---|---|---|
| Ghost ileostomy | Procedure | — | UNRESOLVED |
| No ileostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ghost ileostomy
- description
- Laparoscopic or robotic surgery with ghost ileostomy
- interventionNames
- Procedure: Ghost ileostomy
- type
- ACTIVE_COMPARATOR
- label
- No ileostomy
- description
- Laparoscopic or robotic surgery with no ileostomy
- interventionNames
- Procedure: No 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 total mesorectal excision 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 rectal cancer. * age ≥18 years and ≤80 years. * intraoperative ghost ileostomy or no stoma was performed. Exclusion Criteria: * 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 before 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 (6)
- BACKGROUNDRoodbeen SX, Penna M, Mackenzie H, Kusters M, Slater A, Jones OM, Lindsey I, Guy RJ, Cunningham C, Hompes R. Transanal total mesorectal excision (TaTME) versus laparoscopic TME for MRI-defined low rectal cancer: a propensity score-matched analysis of oncological outcomes. Surg Endosc. 2019 Aug;33(8):2459-2467. doi: 10.1007/s00464-018-6530-4. Epub 2018 Oct 22. PMID 30350103
- BACKGROUNDMori L, Vita M, Razzetta F, Meinero P, D'Ambrosio G. Ghost ileostomy in anterior resection for rectal carcinoma: is it worthwhile? Dis Colon Rectum. 2013 Jan;56(1):29-34. doi: 10.1097/DCR.0b013e3182716ca1. PMID 23222277
- BACKGROUNDLee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862. PMID 29916871
- 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
- BACKGROUNDPalumbo P, Usai S, Pansa A, Lucchese S, Caronna R, Bona S. Anastomotic Leakage in Rectal Surgery: Role of the Ghost Ileostomy. Anticancer Res. 2019 Jun;39(6):2975-2983. doi: 10.21873/anticanres.13429. PMID 31177138
- BACKGROUNDMiccini M, Amore Bonapasta S, Gregori M, Barillari P, Tocchi A. Ghost ileostomy: real and potential advantages. Am J Surg. 2010 Oct;200(4):e55-7. doi: 10.1016/j.amjsurg.2009.12.017. PMID 20887836