Rectal CancerNCT06633133
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
A study testing Virtual ileostomy in people with Rectal Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Virtual ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 1 Oct 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rectal cancer confirmed by pathology
- Age ≥ 18 years
- 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)
- Signed informed consent
- Ability to understand the nature and risks of participating in the trial
Who cannot join
- 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)
Show all 12Show fewer
- Intraoperative combined multi-organ resection
- Combined cirrhosis of the liver
- Intraoperative findings of incomplete anastomosis and positive insufflation test
- Modified Bacon procedure(Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
- Due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary.
- Currently participating in other clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Third Military Medical University
Chongqing, 400042
fan li, PhD, +86 023 68757958, levinecq@163.com
About this study
Official title: Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study
The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:
- Is the virtual ileostomy a safe and effective alternative to the ileostomy?
- Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.
Read more
Participants will:
- Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
- Continuous follow-up of their complications after the first surgery
Read the detailed description
This study is a national multicenter, large-sample, randomized controlled study
- Conditions
- Rectal Cancer
- Being tested
- Virtual ileostomy
- Keywords
- virtual ileostomy, diverting ileostomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual ileostomyProcedure or surgery
A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Virtual ileostomy | Experimental | A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall. Receives: Procedure: Virtual ileostomy |
| Diverting ileostomy | No intervention | Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication index (CCI) at the 6th postoperative month
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 6 month 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 (25)
Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative
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: 5 year
First postoperative complications
First postoperative complications(including abdominal abscess, peritonitis, anastomotic leakage, anastomotic bleeding, pelvic infection, surgical incision infection, peritonitis, anastomotic stenosis, intestinal obstruction, peri-wound complications, incisional hernia, and others) 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: From the date of randomization until the date of discharge, an average of 7 to 14 days
Stoma-related complications
Wounds/abscesses/edema/dermatitis/ulcers around the diverting Ileostomy; parastomal hernia; stoma prolapse; acute kidney injury; dehydration/output >1500 mL/day； other stoma-related complications
Measured: Through study completion, an average of 5 year
Complications after ileostomy closure
Anastomotic leakage； intestinal anastomotic leakage； anastomotic stenosis; bowel obstruction; other wound complications （Wound dehiscence/bleeding/sinus tract/abscess/fat liquefaction）; burst abdomen (dehiscence of abdominal fascia); incisional hernia; fecal incontinence; reoperation; other complications
Measured: Through study completion, an average of 5 year
Postoperative hospitalization days(Initial and all subsequent hospitalizations)
Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group 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 days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Measured: Through study completion, an average of 5 year
The number of hospitalizations(Initial and all subsequent hospitalizations)
Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalizations after low anterior resection for rectal cancer. If the virtual stoma group 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 number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Measured: Through study completion, an average of 5 year
Duration of bearing the stoma (months)
If the virtual stoma group 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 duration of bearing the stoma since the data of surgery of diverting ileostomy.
Measured: Through study completion, an average of 5 year
Total hospitalization costs(Initial and all subsequent hospitalizations)
Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after the first surgery for rectal cancer, if the virtual stoma group required bedside or secondary surgery for converted to 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 the first surgery for rectal cancer.
Measured: Through study completion, an average of 5 year
Number of participants with terminal ostomy
Hartmann's procedure or for example, abdominoperineal extirpation，and transverse colostomy
Measured: Through study completion, an average of 5 year
Number of Participants with unscheduled secondary surgery
Patients performed unscheduled secondary surgery due to complications.
Measured: Through study completion, an average of 5 year
The rate at which virtual ileostomy was converted to diverting ileostomy
The virtual ileostomy group required bedside or secondary surgery to convert to diverting ileostomy due to complications
Measured: Through study completion, an average of 5 year
Virtual ileostomy remove time(days)
Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
Measured: During hospitalization,approximately 14 days
Bile acid concentration of drainage fluid
The investigators are monitoring the concentration of bile acids in the first postoperative drainage fluid.
Measured: During hospitalization,approximately 7 days
Number of participants with stoma (terminal/loop) at 6 months after initial surgery
Patients carrying stoma 6 months after the first surgery for rectal cancer
Measured: 6 months from the date of first surgery for rectal cancer
Interventional drainage rate
Patient requires interventional drainage due to complications.
Measured: Through study completion, an average of 5 year
Fecal Incontinence Scale(Wexner Score)
The defecation function of all postoperative patients. Wexner score range is 0-20 points, with 0 points indicating normal and 20 points indicating complete incontinence.
Measured: Through study completion, an average of 5 year
Quality of life(EORTC QLQ-C30)
The quality of life of all patients was assessed using relevant scales[EORTC (The European Organization for Reasearch and Treatment of Cancer) QLQ-C30(Quality of Life Questionnare-Core 30)]. The EORTC QLQ-C30 (V3. O) consists of 30 entries, which can be divided into 15 domains, including 5 functional domains (physical, role, cognitive, emotional, and social functions), 3 symptom domains (fatigue, pain, nausea, and vomiting), 1 overall health/quality of life domain, and 6 individual entries (each as a domain). EORTC QLQ-C30 has a total of 30 entries. Among them, entries 29 and 30 are divided into seven levels, ranging from 1 to 7 points based on their answer options; the other entries are divided into 4 levels: none(1 point), a little（2 points）, more（3 points）, many（4 points）. The QLQ-C30 scale is reversed except for items 29 and 30 (the higher the value, the worse the quality of life).
Measured: Through study completion, an average of 5 year
Disease free survival (DFS)
Disease free survival
Measured: Through study completion, an average of 5 year
Overall survival (OS)
Overall survival
Measured: Through study completion, an average of 5 year
Rate of permanent ileostomy
Patients who underwent diverting Ileostomy were converted to permanent ileostomy.
Measured: From the date of first surgery,an average of 3 year
Completion of intended perioperative or adjuvant chemotherapy
Completion of intended perioperative or adjuvant chemotherapy
Measured: Through study completion, an average of 5 year
Low anterior resection syndrome for rectal cancer
The investigators use LARS scale to evaluate the patient's defecation function.The LARS rating scale consists of 5 questions: voiding incontinence, fluid voiding incontinence, frequency of voiding, voiding aggregation, and voiding urgency. 0-20 is classified as no LARS, 21-29 is classified as mild LARS, 30-42 is classified as severe LARS.
Measured: Through study completion, an average of 5 year
Quality of life for fecal incontinence
The Fecal Incontinence Quality of Life Scale (FIQL) is mainly used to evaluate the quality of life of patients with fecal incontinence. It includes four main aspects: lifestyle changes, psychological coping/behavioral limitations, depression/self-perception, and social embarrassment. The FIQL is analyzed as a total score; the higher the patient's score, the higher the patient's quality of life.
Measured: Through study completion, an average of 5 year
Permanent ileostomy rate
Patients with diverting ileostomy who underwent sphincter-saving surgery for rectal cancer were converted to permanent ileostomy.
Measured: 3 years from the date of first surgery for rectal cancer
Mortality
30-day mortality
Measured: 30 days from the date of first surgery for rectal cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start10 Oct 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fan li, Study chair, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633133
- Sponsor's protocol ID
- VIRTUAL 01
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34816571Zhao 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 34613330Lightner AL, Vogel JD, Carmichael JC, Keller DS, Shah SA, Mahadevan U, Kane SV, Paquette IM, Steele SR, Feingold DL. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Surgical Management of Crohn's Disease. Dis Colon Rectum. 2020 Aug;63(8):1028-1052. doi: 10.1097/DCR.0000000000001716. No abstract available.
PubMed 32692069Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; TaTME Registry Collaborative. Transanal Total Mesorectal Excision: International Registry Results of the First 720 Cases. Ann Surg. 2017 Jul;266(1):111-117. doi: 10.1097/SLA.0000000000001948.
PubMed 27735827Palumbo 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 31177138Huttner 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.
PubMed 33060088Sacchi 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.
PubMed 18019692Baloyiannis 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.
PubMed 31820192Zenger 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.
PubMed 33537875Miccini 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 20887836Cerroni M, Cirocchi R, Morelli U, Trastulli S, Desiderio J, Mezzacapo M, Listorti C, Esperti L, Milani D, Avenia N, Gulla N, Noya G, Boselli C. Ghost Ileostomy with or without abdominal parietal split. World J Surg Oncol. 2011 Aug 18;9:92. doi: 10.1186/1477-7819-9-92.
PubMed 21849090Mori 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 23222277McKechnie T, Lee J, Lee Y, Tessier L, Amin N, Doumouras A, Hong D, Eskicioglu C. Ghost Ileostomy Versus Loop Ileostomy Following Oncologic Resection for Rectal Cancer: A Systematic Review and Meta-Analysis. Surg Innov. 2023 Aug;30(4):501-516. doi: 10.1177/15533506231169066. Epub 2023 Apr 4.
PubMed 37013791Flor-Lorente B, Sanchez-Guillen L, Pellino G, Frasson M, Garcia-Granero A, Ponce M, Domingo S, Paya V, Garcia-Granero E. "Virtual ileostomy" combined with early endoscopy to avoid a diversion ileostomy in low or ultralow colorectal anastomoses. A preliminary report. Langenbecks Arch Surg. 2019 May;404(3):375-383. doi: 10.1007/s00423-019-01776-z. Epub 2019 Mar 27.
PubMed 30919049
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study
- ClinicalTrials.gov ID
- NCT06633133
- Acronym / sponsor ID
- VIRTUAL 01
- Conditions
- Rectal Cancer
- Keywords
- virtual ileostomy, diverting ileostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 9 Oct 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.
The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:
- Is the virtual ileostomy a safe and effective alternative to the ileostomy?
- Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.
Participants will:
- Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
- Continuous follow-up of their complications after the first surgery
Detailed description
This study is a national multicenter, large-sample, randomized controlled study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual ileostomy | Experimental | Procedure: Virtual ileostomyA pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall. |
| Diverting ileostomy | No intervention | –Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of rectal cancer confirmed by pathology
- Age ≥ 18 years
- 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)
- Signed informed consent
- Ability to understand the nature and risks of participating in the trial
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Virtual ileostomyA pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall. | Procedure or surgery | Virtual ileostomy |
Primary outcome
Comprehensive Complication index (CCI) at the 6th postoperative month
Time frame: An average of 6 month from the date of low anterior resection 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.
25 secondary outcomes
Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative
Time frame: 5 year
First postoperative complications
Time frame: From the date of randomization until the date of discharge, an average of 7 to 14 days
Stoma-related complications
Time frame: Through study completion, an average of 5 year
Complications after ileostomy closure
Time frame: Through study completion, an average of 5 year
Postoperative hospitalization days(Initial and all subsequent hospitalizations)
Time frame: Through study completion, an average of 5 year
The number of hospitalizations(Initial and all subsequent hospitalizations)
Time frame: Through study completion, an average of 5 year
Duration of bearing the stoma (months)
Time frame: Through study completion, an average of 5 year
Total hospitalization costs(Initial and all subsequent hospitalizations)
Time frame: Through study completion, an average of 5 year
Number of participants with terminal ostomy
Time frame: Through study completion, an average of 5 year
Number of Participants with unscheduled secondary surgery
Time frame: Through study completion, an average of 5 year
The rate at which virtual ileostomy was converted to diverting ileostomy
Time frame: Through study completion, an average of 5 year
Virtual ileostomy remove time(days)
Time frame: During hospitalization,approximately 14 days
Bile acid concentration of drainage fluid
Time frame: During hospitalization,approximately 7 days
Number of participants with stoma (terminal/loop) at 6 months after initial surgery
Time frame: 6 months from the date of first surgery for rectal cancer
Interventional drainage rate
Time frame: Through study completion, an average of 5 year
Fecal Incontinence Scale(Wexner Score)
Time frame: Through study completion, an average of 5 year
Quality of life(EORTC QLQ-C30)
Time frame: Through study completion, an average of 5 year
Disease free survival (DFS)
Time frame: Through study completion, an average of 5 year
Overall survival (OS)
Time frame: Through study completion, an average of 5 year
Rate of permanent ileostomy
Time frame: From the date of first surgery,an average of 3 year
Completion of intended perioperative or adjuvant chemotherapy
Time frame: Through study completion, an average of 5 year
Low anterior resection syndrome for rectal cancer
Time frame: Through study completion, an average of 5 year
Quality of life for fecal incontinence
Time frame: Through study completion, an average of 5 year
Permanent ileostomy rate
Time frame: 3 years from the date of first surgery for rectal cancer
Mortality
Time frame: 30 days from the date of first surgery for rectal cancer
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 16 Oct 2024.
- Background: PubMed 34816571Degiuli 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.
- 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 32692069Lightner AL, Vogel JD, Carmichael JC, Keller DS, Shah SA, Mahadevan U, Kane SV, Paquette IM, Steele SR, Feingold DL. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Surgical Management of Crohn's Disease. Dis Colon Rectum. 2020 Aug;63(8):1028-1052. doi: 10.1097/DCR.0000000000001716. No abstract available.
- Background: PubMed 27735827Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; TaTME Registry Collaborative. Transanal Total Mesorectal Excision: International Registry Results of the First 720 Cases. Ann Surg. 2017 Jul;266(1):111-117. doi: 10.1097/SLA.0000000000001948.
- 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 33060088Huttner 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.
- Background: PubMed 18019692Sacchi 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.
- Background: PubMed 31820192Baloyiannis 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.
- Background: PubMed 33537875Zenger 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.
- 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.
- Background: PubMed 21849090Cerroni M, Cirocchi R, Morelli U, Trastulli S, Desiderio J, Mezzacapo M, Listorti C, Esperti L, Milani D, Avenia N, Gulla N, Noya G, Boselli C. Ghost Ileostomy with or without abdominal parietal split. World J Surg Oncol. 2011 Aug 18;9:92. doi: 10.1186/1477-7819-9-92.
- 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.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
fan li study chair
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual ileostomy in people with Rectal Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact fan li, PhD (18696539200, levinecq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication index (CCI) at the 6th postoperative month (time frame: An average of 6 month from the date of low anterior resection 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 NCT06633133, which also lists 14 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 16 Oct 2024.