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NCT Number: NCT06650085

Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

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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Key information

Conditions

Stoma Colostomy Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loop ileostomy

Procedure

Patient undergoing anterior rectal resection will receive loop ileostomy

Loop colostomy

Procedure

Patient undergoing anterior rectal resection will receive loop colostomy

Primary outcomes

  1. Stoma-related adverse events

    Time frame: Within 60 days from randomization

    Stoma-related adverse events score by using Comprehensive Complication Index

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 30 days from randomization

    All complications scored using Comprehensive Complication Index

  2. Postoperative complications after stoma closure

    Time frame: Within 30 days from 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)

  3. Hospital-free days

    Time frame: Within 30 days from randomization

    Days patient is alive and out of any hospital

  4. Quality of life

    Time frame: At 2 months from randomization

    Quality of life measured using EORTC Quality of life questionnaires core 30 with colorectal 29 extension (QLQ-C30+QLQ-CR29)

  5. Kidney function change

    Time frame: Within 1 year from randomization

    Kidney function change defined as difference in eGFR before and 1 year after randomization

Other outcomes

  1. 5-year overall survival

    Time frame: Within 5 years from randomization

    Number of patients alive within 5 years from randomization

  2. 5-year disease-free survival

    Time frame: Within 5 years from randomization

    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)

  3. Kidney function change at 5 years

    Time frame: Within 5 years from randomization

    Kidney function change defined as difference in eGFR before and 5 years after randomization

  4. Incisional hernia

    Time frame: Within 5 years from randomization

    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)

  5. Stoma closure

    Time frame: Within 5 years from randomization

    Cumulative death-censored successful stoma closure

  6. Quality of life at 5 years

    Time frame: At 5 years from randomization

    Quality of life measured using QLQ-C30 with QLQ-CR29 extension

  7. Quality of life at 5 years

    Time frame: At 5 years from randomization

    Quality of life measured using EQ-5D-5L

  8. Quality of life at 5 years

    Time frame: At 5 years from randomization

    Quality of life measured using low anterior resection syndrome score (LARS scores)

  9. Quality of life at 1 year

    Time frame: At 1 year from randomization

    Quality of life measured using low anterior resection syndrome score (LARS scores)

  10. Quality of life at 6 months

    Time frame: At 6 months from randomization

    Quality of life measured using low anterior resection syndrome score (LARS scores)

  11. Quality of life at 1 year

    Time frame: At 1 year from randomization

    Quality of life measured using EQ-5D-5L

  12. Quality of life at 6 months

    Time frame: At 6 months from randomization

    Quality of life measured using EQ-5D-5L

  13. Quality of life at 2 months

    Time frame: At 2 months from randomization

    Quality of life measured using EQ-5D-5L

  14. Quality of life at 1 year

    Time frame: At 1 year from randomization

    Quality of life measured using QLQ-C30 with QLQ-CR29 extension

  15. Quality of life at 6 months

    Time frame: At 6 months from randomization

    Quality of life measured using QLQ-C30 with QLQ-CR29 extension

  16. Anastomotic leakage

    Time frame: Within 60 days from randomization

    Total number of anastomotic leakages reported also with grading (Rahbari et al., 2010)

  17. Intestinal microbiome

    Time frame: Within 5 years from randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Koskenvuo, MD, PhD

CONTACT

[email protected]

+358-9-4711

Ville Sallinen, MD, PhD

CONTACT

[email protected]

+358-9-4711

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Helsinki University Hospital Research Funds
  • Mary and Georg Ehrnrooth's foundation

Registry information

Official study title

PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)

Acronym: PROSPERITY

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Oct 21, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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