No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer

NCT06225609 | Not Yet Recruiting

• 1 other identifier: Ghost 002
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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 group versus no ileostomy group after total mesorectal excision for rectal cancer.

Conditions

Rectal Neoplasms

Keywords

Ghost ileostomy; No ileostomy; Rectal cancer

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 (5)

• 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

• First hospitalization costs

  During hospitalization,approximately 7 days

• Total hospitalization costs

  Through study completion, an average of 1 year

Other Outcomes (5)

• Whether patients undergo terminal ostomy after total mesorectal excision for rectal cancer.

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

• The number of patients who required secondary abdominal surgery under general anesthesia due to complications

  Through study completion, an average of 1 year

Study Arms (2)

Ghost ileostomy

EXPERIMENTAL

Laparoscopic or robotic surgery with ghost ileostomy

Procedure: Ghost ileostomy

No ileostomy

ACTIVE COMPARATOR

Laparoscopic or robotic surgery with no ileostomy

Procedure: No ileostomy

Interventions

Ghost ileostomy PROCEDURE

Laparoscopic or robotic surgery with ghost ileostomy

Ghost ileostomy

No ileostomy PROCEDURE

Laparoscopic or robotic surgery with no ileostomy

No ileostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed rectal cancer.
• age ≥18 years and ≤80 years.
• intraoperative ghost ileostomy or no stoma was performed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• fan li: lead

Related Publications (6)

• Roodbeen 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 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

• Lee 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 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

• 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

• 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

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share