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| Name | Class |
|---|---|
| Mary and Georg Ehrnrooth's foundation | UNKNOWN |
| Helsinki University Hospital Research Funds | UNKNOWN |
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Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loop ileostomy | Experimental |
| |
| Loop colostomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loop ileostomy | Procedure | Patient undergoing anterior rectal resection will receive loop ileostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stoma-related adverse events | Stoma-related adverse events score by using Comprehensive Complication Index | Within 60 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | All complications scored using Comprehensive Complication Index | Within 30 days from randomization |
| Postoperative complications after stoma closure | All complications after stoma closure using Comprehensive Complication Index (including only patients who have undergone stoma closure within 1 year from primary surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | Number of patients alive within 5 years from randomization | Within 5 years from randomization |
| 5-year disease-free survival | Number of patients alive and disease-free within 5 years from randomization (including only patients with M0 at primary operation undergoing radical R0/1 surgery) |
Inclusion Criteria: Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.
The exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age <18 years, (4) inadequate ability to co-operate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Koskenvuo, MD, PhD | Contact | +358-9-4711 | laura.koskenvuo@hus.fi | |
| Ville Sallinen, MD, PhD | Contact | +358-9-4711 | ville.sallinen@helsinki.fi |
| Name | Affiliation | Role |
|---|---|---|
| Ville Sallinen, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40335149 | Derived | Koskenvuo L, Paajanen P, Varpe P, Seppala T, Mentula P, Haapamaki C, Carpelan-Holmstrom M, Carpelan A, Lehto K, Satokari R, Lepisto A, Sallinen V. PROtective ileoStomy versus ProtectivE colostomy in anterior Rectal resectIon: study protocol for a multicenter, open-label, randomised conTrolled studY (PROSPERITY). BMJ Open. 2025 May 6;15(5):e096091. doi: 10.1136/bmjopen-2024-096091. |
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| ID | Term |
|---|---|
| D007081 | Ileostomy |
| ID | Term |
|---|---|
| D004766 | Enterostomy |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010030 | Ostomy |
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| Loop colostomy | Procedure | Patient undergoing anterior rectal resection will receive loop colostomy |
|
| Within 30 days from stoma closure |
| Hospital-free days | Days patient is alive and out of any hospital | Within 30 days from randomization |
| Quality of life | Quality of life measured using EORTC Quality of life questionnaires core 30 with colorectal 29 extension (QLQ-C30+QLQ-CR29) | At 2 months from randomization |
| Kidney function change | Kidney function change defined as difference in eGFR before and 1 year after randomization | Within 1 year from randomization |
| Within 5 years from randomization |
| Kidney function change at 5 years | Kidney function change defined as difference in eGFR before and 5 years after randomization | Within 5 years from randomization |
| Incisional hernia | Number of incision hernias of ostomy site (only patients who have undergone successful stoma closure and alive at 5 years will be included in this analysis) | Within 5 years from randomization |
| Stoma closure | Cumulative death-censored successful stoma closure | Within 5 years from randomization |
| Quality of life at 5 years | Quality of life measured using QLQ-C30 with QLQ-CR29 extension | At 5 years from randomization |
| Quality of life at 5 years | Quality of life measured using EQ-5D-5L | At 5 years from randomization |
| Quality of life at 5 years | Quality of life measured using low anterior resection syndrome score (LARS scores) | At 5 years from randomization |
| Quality of life at 1 year | Quality of life measured using low anterior resection syndrome score (LARS scores) | At 1 year from randomization |
| Quality of life at 6 months | Quality of life measured using low anterior resection syndrome score (LARS scores) | At 6 months from randomization |
| Quality of life at 1 year | Quality of life measured using EQ-5D-5L | At 1 year from randomization |
| Quality of life at 6 months | Quality of life measured using EQ-5D-5L | At 6 months from randomization |
| Quality of life at 2 months | Quality of life measured using EQ-5D-5L | At 2 months from randomization |
| Quality of life at 1 year | Quality of life measured using QLQ-C30 with QLQ-CR29 extension | At 1 year from randomization |
| Quality of life at 6 months | Quality of life measured using QLQ-C30 with QLQ-CR29 extension | At 6 months from randomization |
| Anastomotic leakage | Total number of anastomotic leakages reported also with grading (Rahbari et al., 2010) | Within 60 days from randomization |
| Intestinal microbiome | Intestinal microbiome (only patients of the Helsinki University Hospital) composition and functional potential during the stoma in place and stabilization of microbiome after stoma closure. | Within 5 years from randomization |
| Tampere University Hospital | Recruiting | Tampere | Finland |
|
| Turku University Hospital | Recruiting | Turku | Finland |
|