Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

NCT ID: NCT06650085

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2032-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loop ileostomy

Group Type: EXPERIMENTAL

Loop ileostomy

Intervention Type: PROCEDURE

Patient undergoing anterior rectal resection will receive loop ileostomy

Loop colostomy

Group Type: ACTIVE_COMPARATOR

Loop colostomy

Intervention Type: PROCEDURE

Patient undergoing anterior rectal resection will receive loop colostomy

Interventions

Loop ileostomy

Patient undergoing anterior rectal resection will receive loop ileostomy

Intervention Type: PROCEDURE

Loop colostomy

Patient undergoing anterior rectal resection will receive loop colostomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mary and Georg Ehrnrooth's foundation

UNKNOWN

Sponsor Role: collaborator

Helsinki University Hospital Research Funds

UNKNOWN

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ville Sallinen

Adj. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ville Sallinen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki University Hospital

Helsinki, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Countries

Finland

Central Contacts

Laura Koskenvuo, MD, PhD

Role: CONTACT

laura.koskenvuo@hus.fi

+358-9-4711

Ville Sallinen, MD, PhD

Role: CONTACT

ville.sallinen@helsinki.fi

+358-9-4711

Facility Contacts

Laura Koskenvuo, MD, PhD

Role: primary

laura.koskenvuo@hus.fi

Toni Seppälä, MD, PhD

Role: primary

toni.seppala@tuni.fi

Pirita Varpe, MD, PhD

Role: primary

pirita.varpe@tyks.fi

References

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.

Reference Type: DERIVED

PMID: 40335149 (View on PubMed)

Other Identifiers

PROSPERITY

Identifier Type: -

Identifier Source: org_study_id