Clinical trial NCT06225609: No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer
Official title: Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Ghost ileostomy
No ileostomy
Rectal cancer
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: So far, there are no relevant reports on ghost ileostomy among the Asian population, and all studies are small sample studies.In the past decades, with the advent of circular stapling devices, many middle and low rectal cancers have chosen new sphincter-saving procedures (such as ISR and Ta TME). Nevertheless, when the incidence rate of AL remains high, is diverting ileostomy applicable? Is ghost ileostomy applicable to rectal cancer in the context of new surgical procedures such as pelvic floor reconstruction, perineal drainage, anastomotic reinforcement and robotic surgery? Is this delayed stoma safe and feasible with the increase of preoperative neoadjuvant therapy? Therefore, our study proposes to summarize the review of the complications of GI and no stoma to explore the safety and effectiveness of GI in clinical practice.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
timeFrame: 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:
measure: Postoperative hospitalization days
timeFrame: Through study completion, an average of 1 year
measure: Readmission rates
timeFrame: Through study completion, an average of 1 year
measure: The number of hospitalizations
timeFrame: Through study completion, an average of 1 year
measure: First hospitalization costs
timeFrame: During hospitalization,approximately 7 days
measure: Total hospitalization costs
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Whether patients undergo terminal ostomy after total mesorectal excision for rectal cancer.
timeFrame: Through study completion, an average of 1 year
measure: The number of participants with ghost ileostomy converted to diverting ileostomy
timeFrame: Through study completion, an average of 1 year
measure: The number of patients who required secondary abdominal surgery under general anesthesia due to complications
timeFrame: Through study completion, an average of 1 year
measure: Ghost ileostomy remove time
timeFrame: During hospitalization,approximately 7 days
measure: The number of patients with complications after total mesorectal excision for rectal cancer
timeFrame: Through study completion, an average of 1 year
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.