Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

NCT06633133 | Recruiting DMC

• 1 other identifier: VIRTUAL 01
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Keywords

virtual ileostomy; diverting ileostomy

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication index (CCI) at the 6th postoperative month

  The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.

  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 Outcomes (25)

• Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative

  5 year

• First postoperative complications

  From the date of randomization until the date of discharge, an average of 7 to 14 days

• Stoma-related complications

  Through study completion, an average of 5 year

• Complications after ileostomy closure

  Through study completion, an average of 5 year

• Postoperative hospitalization days(Initial and all subsequent hospitalizations)

  Through study completion, an average of 5 year

Study Arms (2)

Virtual ileostomy

EXPERIMENTAL

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.

Procedure: Virtual ileostomy

Diverting ileostomy

NO INTERVENTION

Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications.

Interventions

Virtual ileostomy PROCEDURE

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.

Virtual ileostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, 400042, China

RECRUITING

Related Publications (14)

• 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 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Zenger S, Gurbuz B, Can U, Balik E, Yalti T, Bugra D. Comparative study between ghost ileostomy and defunctioning ileostomy in terms of morbidity and cost-effectiveness in low anterior resection for rectal cancer. Langenbecks Arch Surg. 2021 Mar;406(2):339-347. doi: 10.1007/s00423-021-02089-w. Epub 2021 Feb 4.

  PMID: 33537875 BACKGROUND

• Miccini 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 BACKGROUND

• Cerroni M, Cirocchi R, Morelli U, Trastulli S, Desiderio J, Mezzacapo M, Listorti C, Esperti L, Milani D, Avenia N, Gulla N, Noya G, Boselli C. Ghost Ileostomy with or without abdominal parietal split. World J Surg Oncol. 2011 Aug 18;9:92. doi: 10.1186/1477-7819-9-92.

  PMID: 21849090 BACKGROUND

• Mori 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 BACKGROUND

• McKechnie T, Lee J, Lee Y, Tessier L, Amin N, Doumouras A, Hong D, Eskicioglu C. Ghost Ileostomy Versus Loop Ileostomy Following Oncologic Resection for Rectal Cancer: A Systematic Review and Meta-Analysis. Surg Innov. 2023 Aug;30(4):501-516. doi: 10.1177/15533506231169066. Epub 2023 Apr 4.

  PMID: 37013791 BACKGROUND

• Flor-Lorente B, Sanchez-Guillen L, Pellino G, Frasson M, Garcia-Granero A, Ponce M, Domingo S, Paya V, Garcia-Granero E. "Virtual ileostomy" combined with early endoscopy to avoid a diversion ileostomy in low or ultralow colorectal anastomoses. A preliminary report. Langenbecks Arch Surg. 2019 May;404(3):375-383. doi: 10.1007/s00423-019-01776-z. Epub 2019 Mar 27.

  PMID: 30919049 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• fan li

  Daping Hospital, Third Military Medical University

  STUDY CHAIR

Central Study Contacts

fan li, PhD

CONTACT

18696539200; levinecq@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 9, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2030
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)