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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:
Participants will:
This study is a national multicenter, large-sample, randomized controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual ileostomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fan li, PhD | Contact | 18696539200 | levinecq@163.com |
| Name | Affiliation | Role |
|---|---|---|
| fan li | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Third Military Medical University | Recruiting | Chongqing | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34816571 | Background | 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. | |
| 34613330 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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. | 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 | 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 | 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. | 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. | 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. | 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. | 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 | Through study completion, an average of 5 year |
| Number of Participants with unscheduled secondary surgery | Patients performed unscheduled secondary surgery due to complications. | 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 | 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. | 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. | 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 | 6 months from the date of first surgery for rectal cancer |
| Interventional drainage rate | Patient requires interventional drainage due to complications. | 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. | 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). | Through study completion, an average of 5 year |
| Disease free survival (DFS) | Disease free survival | Through study completion, an average of 5 year |
| Overall survival (OS) | Overall survival | Through study completion, an average of 5 year |
| Rate of permanent ileostomy | Patients who underwent diverting Ileostomy were converted to permanent ileostomy. | 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 | 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. | 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. | 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. | 3 years from the date of first surgery for rectal cancer |
| Mortality | 30-day mortality | 30 days from the date of first surgery for rectal cancer |
| 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. |
| 32692069 | Background | Lightner 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. |
| 27735827 | Background | Penna 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. |
| 31177138 | 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. |
| 33060088 | Background | 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. |
| 18019692 | Background | 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. |
| 31820192 | Background | 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. |
| 33537875 | Background | 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. |
| 20887836 | 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. |
| 21849090 | Background | Cerroni 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. |
| 23222277 | 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. |
| 37013791 | Background | McKechnie 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. |
| 30919049 | Background | Flor-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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |