Rectal NeoplasmsNCT06225609
No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer
A study testing Ghost ileostomy and No ileostomy in people with Rectal Neoplasms, run by fan li.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Ghost ileostomy and No ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathologically confirmed rectal cancer.
- age ≥18 years and ≤80 years.
- intraoperative ghost ileostomy or no stoma was performed.
Who cannot join
- 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).
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- Intraoperative combined multi-organ resection.
- Combined cirrhosis of the liver.
- Intraoperative findings of incomplete anastomosis and positive insufflation test.
About this study
Official title: Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Rectal Neoplasms
- Being tested
- Ghost ileostomy, No ileostomy
- Keywords
- Ghost ileostomy, No ileostomy, Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ghost ileostomyProcedure or surgery
Laparoscopic or robotic surgery with ghost ileostomy
No ileostomyProcedure or surgery
Laparoscopic or robotic surgery with no ileostomy
| Study group | Role | What they receive |
|---|---|---|
| Ghost ileostomy | Experimental | Laparoscopic or robotic surgery with ghost ileostomy Receives: Procedure: Ghost ileostomy |
| No ileostomy | Active comparator | Laparoscopic or robotic surgery with no ileostomy Receives: Procedure: No ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
If the ghost ileostomy group required bed rest or a second surgery for ileostomy due to complications or no stoma group required a second surgery due to complications, the number of days of hospitalization due to complications and/or reoperation since total mesorectal excision for rectal cancer was recorded.
Measured: Through study completion, an average of 1 year
Readmission rates
Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.
Measured: Through study completion, an average of 1 year
The number of hospitalizations
Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.
Measured: Through study completion, an average of 1 year
First hospitalization costs
Patient hospitalization costs for total mesorectal excision of rectal cancer.
Measured: During hospitalization,approximately 7 days
Total hospitalization costs
Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the costs total mesorectal excision for rectal cancer, if the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of total mesorectal excision for rectal cancer.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- fan li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225609
- Sponsor's protocol ID
- Ghost 002
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30350103Mori 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.
PubMed 23222277Lee 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.
PubMed 29916871Zhao 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.
PubMed 34613330Palumbo 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.
PubMed 31177138Miccini 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.
PubMed 20887836
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06225609
- Acronym / sponsor ID
- Ghost 002
- Conditions
- Rectal Neoplasms
- Keywords
- Ghost ileostomy, No ileostomy, Rectal cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- fan liUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ghost ileostomy | Experimental | Procedure: Ghost ileostomyLaparoscopic or robotic surgery with ghost ileostomy |
| No ileostomy | Active comparator | Procedure: No ileostomyLaparoscopic or robotic surgery with no ileostomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologically confirmed rectal cancer.
- age ≥18 years and ≤80 years.
- intraoperative ghost ileostomy or no stoma was performed.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ghost ileostomyLaparoscopic or robotic surgery with ghost ileostomy | Procedure or surgery | Ghost ileostomy |
| No ileostomyLaparoscopic or robotic surgery with no ileostomy | Procedure or surgery | No ileostomy |
Primary outcome
Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
Time frame: 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
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.
5 secondary outcomes
Postoperative hospitalization days
Time frame: Through study completion, an average of 1 year
Readmission rates
Time frame: Through study completion, an average of 1 year
The number of hospitalizations
Time frame: Through study completion, an average of 1 year
First hospitalization costs
Time frame: During hospitalization,approximately 7 days
Total hospitalization costs
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 30350103Roodbeen 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.
- Background: PubMed 23222277Mori 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.
- Background: PubMed 29916871Lee 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.
- Background: PubMed 34613330Zhao 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.
- Background: PubMed 31177138Palumbo 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.
- Background: PubMed 20887836Miccini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ghost ileostomy and No ileostomy in people with Rectal Neoplasms, run by fan li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225609, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.