Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

Official title

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study

Overview

The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are: * Is the virtual ileostomy a safe and effective alternative to the ileostomy? * Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma. Participants will: * Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer * Continuous follow-up of their complications after the first surgery

Detailed description

This study is a national multicenter, large-sample, randomized controlled study

Interventions

• Procedure Virtual ileostomy
  A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.

Primary outcome measures

• Comprehensive Complication index (CCI) at the 6th postoperative month [Time frame: An average of 6 month from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications]

Secondary outcome measures (12)

• Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative [Time frame: 5 year]
• First postoperative complications [Time frame: From the date of randomization until the date of discharge, an average of 7 to 14 days]
• Stoma-related complications [Time frame: Through study completion, an average of 5 year]
• Complications after ileostomy closure [Time frame: Through study completion, an average of 5 year]
• Postoperative hospitalization days(Initial and all subsequent hospitalizations) [Time frame: Through study completion, an average of 5 year]
• The number of hospitalizations(Initial and all subsequent hospitalizations) [Time frame: Through study completion, an average of 5 year]
• Duration of bearing the stoma (months) [Time frame: Through study completion, an average of 5 year]
• Total hospitalization costs(Initial and all subsequent hospitalizations) [Time frame: Through study completion, an average of 5 year]
• Number of participants with terminal ostomy [Time frame: Through study completion, an average of 5 year]
• Number of Participants with unscheduled secondary surgery [Time frame: Through study completion, an average of 5 year]
• The rate at which virtual ileostomy was converted to diverting ileostomy [Time frame: Through study completion, an average of 5 year]
• Virtual ileostomy remove time(days) [Time frame: During hospitalization,approximately 14 days]

Eligibility criteria

Inclusion criteria

• Diagnosis of rectal cancer confirmed by pathology
• Age ≥ 18 years
• Total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis：1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
• Signed informed consent
• Ability to understand the nature and risks of participating in the trial

Exclusion criteria

• Emergency surgery, open surgery
• ASA score >3points
• Patients with combined complete intestinal obstruction
• Long-term history of using immunosuppressants 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
• Modified Bacon procedure(Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
• Due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary.
• Currently participating in other clinical trials

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• Daping Hospital, Third Military Medical University — Chongqing

Publications

• Degiuli 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 leak PMID 34816571
• Zhao 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
• Lightner AL, Vogel JD, Carmichael JC, Keller DS, Shah SA, Mahadevan U, Kane SV, Paquette IM, Steele SR, Feingold DL. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Surgical Management of Crohn's Disease. Dis Colon Rectum. 2020 Aug;63(8):1028-1052. doi: 10.1097/DCR.0000000000001716. No abstract available. PMID 32692069
• Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; TaTME Registry Collaborative. Transanal Total Mesorectal Excision: International Registry Results of the First 720 Cases. Ann Surg. 2017 Jul;266(1):111-117. doi: 10.1097/SLA.0000000000001948. PMID 27735827
• Palumbo 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
• Huttner FJ, Probst P, Mihaljevic A, Contin P, Dorr-Harim C, Ulrich A, Schneider M, Buchler MW, Diener MK, Knebel P. Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial. BMJ Open. 2020 Oct 15;10(10):e038930. doi: 10.1136/bmjopen-2020-038930. PMID 33060088
• Sacchi M, Legge PD, Picozzi P, Papa F, Giovanni CL, Greco L. Virtual ileostomy following TME and primary sphincter-saving reconstruction for rectal cancer. Hepatogastroenterology. 2007 Sep;54(78):1676-8. PMID 18019692
• Baloyiannis I, Perivoliotis K, Diamantis A, Tzovaras G. Virtual ileostomy in elective colorectal surgery: a systematic review of the literature. Tech Coloproctol. 2020 Jan;24(1):23-31. doi: 10.1007/s10151-019-02127-2. Epub 2019 Dec 9. PMID 31820192

Identifiers

NCT: NCT06633133 · VIRTUAL 01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗