Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

NCT06650085 | Not Yet Recruiting

• 1 other identifier: PROSPERITY
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

Brief Summary

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)).

Conditions

Stoma Colostomy; Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Stoma-related adverse events

  Stoma-related adverse events score by using Comprehensive Complication Index

  Within 60 days from randomization

Secondary Outcomes (5)

• Postoperative complications

  Within 30 days from randomization

• Postoperative complications after stoma closure

  Within 30 days from stoma closure

• Hospital-free days

  Within 30 days from randomization

• Quality of life

  At 2 months from randomization

• Kidney function change

  Within 1 year from randomization

Other Outcomes (17)

• 5-year overall survival

  Within 5 years from randomization

• 5-year disease-free survival

  Within 5 years from randomization

• Kidney function change at 5 years

  Within 5 years from randomization

Study Arms (2)

Loop ileostomy

EXPERIMENTAL

Procedure: Loop ileostomy

Loop colostomy

ACTIVE COMPARATOR

Procedure: Loop colostomy

Interventions

Loop ileostomy PROCEDURE

Patient undergoing anterior rectal resection will receive loop ileostomy

Loop ileostomy

Loop colostomy PROCEDURE

Patient undergoing anterior rectal resection will receive loop colostomy

Loop colostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Mary and Georg Ehrnrooth's foundation: collaborator
• Helsinki University Hospital Research Funds: collaborator

Study Sites (3)

Helsinki University Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 40335149 DERIVED

MeSH Terms

Interventions

Ileostomy

Intervention Hierarchy (Ancestors)

Enterostomy; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Ville Sallinen, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Koskenvuo, MD, PhD

CONTACT

+358-9-4711; laura.koskenvuo@hus.fi

Ville Sallinen, MD, PhD

CONTACT

+358-9-4711; ville.sallinen@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj. Professor

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: October 21, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)