Virtual Ileostomy Versus Diverting Ileostomy

NCT05985239 | Completed

• 1 other identifier: VI vs. DI
• Study Type: observational
• Target: 612
• Locations: 1 country
• Sites: 1

Brief Summary

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 virtual ileostomy versus conventional divertingileostomy after total mesorectal excision for rectal cancer.

Conditions

Rectal Cancer

Keywords

Virtual ileostomy; Diverting ileostomy; Total mesorectal excision

Outcome Measures

Primary Outcomes (1)

• Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient

  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 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

Secondary Outcomes (6)

• Postoperative hospitalization days

  Through study completion, an average of 1 year

• Readmission rates

  Through study completion, an average of 1 year

• The number of hospitalizations

  Through study completion, an average of 1 year

• Duration of bearing the stoma (months)

  Through study completion, an average of 1 year

• First hospitalization costs

  During hospitalization,approximately 7 days

Other Outcomes (7)

• Whether patients undergo terminal ostomy after low anterior resection for rectal cancer.

  Through study completion, an average of 1 year

• Patients with stoma (terminal/loop) at 6 months after initial surgery.

  6 months from the date of total mesorectal excision for rectal cancer

• The number of participants with virtual ileostomy converted to diverting ileostomy.

  Through study completion, an average of 1 year

Study Arms (2)

Virtual ileostomy

Laparoscopic or robotic surgery with virtual ileostomy

Procedure: VI

Diverting ileostomy

Laparoscopic or robotic surgery with diverting ileostomy

Procedure: DI

Interventions

VI PROCEDURE

Laparoscopic or robotic surgery with virtual ileostomy

Virtual ileostomy

DI PROCEDURE

Laparoscopic or robotic surgery with virtual ileostomy

Diverting ileostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent total mesorectal excision for rectal cancer between September 2014 and January 2024.

You may qualify if:

• Diagnosis of rectal cancer confirmed by pathology
• Age ≥ 18 years
• Lap/robot 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)
• 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
• missing information

Sponsors & Collaborators

• fan li: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, 400042, China

Location

Related Publications (11)

• 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

• Chapman 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 BACKGROUND

• Kim 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 BACKGROUND

• Tsujinaka 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 BACKGROUND

• Murken 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.

  PMID: 31061647 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

• 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

• 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

• 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

• 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

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 12, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)