Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection (PROSPERITY)

PROtective IleoStomy Versus ProtectivE Colostomy in Anterior Rectal ResectIon - a Multicenter, Open-label, Randomized ConTrolled StudY (PROSPERITY)

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)).

Study Overview

• Status: Not yet recruiting
• Conditions: Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Procedure: Loop ileostomy; Procedure: Loop colostomy

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ville Sallinen, MD, PhD; Phone Number: +358-9-4711; Email: ville.sallinen@helsinki.fi
• Study Contact Backup: Name: Laura Koskenvuo, MD, PhD; Phone Number: +358-9-4711; Email: laura.koskenvuo@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
    • Contact: Laura Koskenvuo, MD, PhD; Email: laura.koskenvuo@hus.fi
  • Tampere, Finland
    • Tampere University Hospital
    • Contact: Toni Seppälä, MD, PhD; Email: toni.seppala@tuni.fi
  • Turku, Finland
    • Turku University Hospital
    • Contact: Pirita Varpe, MD, PhD; Email: Pirita.Varpe@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loop ileostomy	Procedure: Loop ileostomy; Patient undergoing anterior rectal resection will receive loop ileostomy
Active Comparator: Loop colostomy	Procedure: Loop colostomy; Patient undergoing anterior rectal resection will receive loop colostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stoma-related adverse events	Stoma-related adverse events score by using Comprehensive Complication Index	Within 60 days from randomization

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Mary and Georg Ehrnrooth's foundation; Helsinki University Hospital Research Funds
• Investigators: Principal Investigator: Ville Sallinen, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PROSPERITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No