NCT07037693

Brief Summary

Postoperative complications after rectal resection can worsen the short-term postoperative outcomes and the long-term survival. This study aims to compare the comprehensive complication index (CCI) and the commonly used Clavien-Dindo classification (CDC) in predicting postoperative outcomes after rectal resection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
958

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

12.5 years

First QC Date

June 6, 2025

Last Update Submit

June 23, 2025

Conditions

Rectal Diseases

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    The predictive ability of the comprehensive-complication index and the Clavien-Dindo classification regarding the length of hospital stay after rectal resection will be compared through an area under the curve (AUC) analysis.

    Periprocedural

Secondary Outcomes (4)

  • 30-day readmission rate

    30 days

  • 90-day mortality

    90 days

  • Overall survival

    5 years

  • Comprehensive measure

    30 days

Study Arms (2)

CCI

Diagnostic Test: Comprehensive complication index (CCI)

CDC

Diagnostic Test: Clavien-Dindo-Classification (CDC)

Interventions

Comprehensive complication index (CCI)DIAGNOSTIC_TEST

Comprehensive complication index (CCI)

CCI
Clavien-Dindo-Classification (CDC)DIAGNOSTIC_TEST

Clavien-Dindo-Classification (CDC)

CDC

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with rectal resection at the Cantonal Hospital of St.Gallen between 2012 and June 2024.

You may qualify if:

  • All patients with rectal resection at the Cantonal Hospital of St.Gallen between 2012 and June 2024.

You may not qualify if:

  • Missing CCI data
  • Missing CDC data
  • Incomplete 30-day follow-up
  • Decline to have their information included in the scientific data analysis
  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOCH Health Ostschweiz, Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Rectal Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 25, 2025

Study Start

January 1, 2012

Primary Completion

June 30, 2024

Study Completion

November 30, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)