NCT05985252

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 ghost ileostomy versus conventional loop ileostomy after low anterior resection for rectal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

July 14, 2023

Last Update Submit

August 8, 2023

Conditions

Rectal Neoplasms

Keywords

Virtual ileostomyDiverting ileostomyRectal NeoplasmsRectosigmoid junction

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 low anterior resection 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

  • +1 more secondary outcomes

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 low anterior resection for rectal cancer

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

    Through study completion, an average of 1 year

  • +4 more other outcomes

Study Arms (2)

Virtual ileostomy

EXPERIMENTAL

Laparoscopic or robotic surgery with virtual ileostomy

Procedure: Virtual ileostomy

Diverting ileostomy

ACTIVE COMPARATOR

Laparoscopic or robotic surgery with diverting ileostomy

Procedure: Diverting ileostomy

Interventions

Virtual ileostomyPROCEDURE

Laparoscopic or robotic surgery with virtual ileostomy

Virtual ileostomy
Diverting ileostomyPROCEDURE

Laparoscopic or robotic surgery with diverting ileostomy

Diverting ileostomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Daping hospital

Chongqing, 400042, China

Location

Daping Hospital, Third Military Medical University

Chongqing, 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: 34816571BACKGROUND

  • 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: 34613330BACKGROUND

  • 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: 30639302BACKGROUND

  • 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: 30109482BACKGROUND

  • 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: 36620340BACKGROUND

  • 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: 31061647BACKGROUND

  • 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: 33060088BACKGROUND

  • 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: 20887836BACKGROUND

  • 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: 18019692BACKGROUND

  • 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: 33537875BACKGROUND

  • 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: 31820192BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • fan li

    Daping Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

fan li

CONTACT

+86 023 68757958levinecq@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 14, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion

December 31, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)