NCT03292289

Brief Summary

This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

September 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

September 18, 2017

Last Update Submit

March 16, 2026

Conditions

Rectal Cancer

Keywords

proctectomycoloanal continuity reconstruction

Outcome Measures

Primary Outcomes (1)

  • Quality of life 1 year after the second intervention, using LARS score

    Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")

    from baseline to 1 year after the second intervention

Secondary Outcomes (9)

  • Quality of life before the first intervention and after the second intervention

    from baseline to one year after the 2nd intervention

  • Quality of life using EORTC-QLQ-C30

    from baseline to one year after the 2nd intervention

  • Quality of life using EORTC-QLQ-CR29 questionnaires

    from baseline to one year after the 2nd intervention

  • Impact of stomy on quality of life

    from the first intervention to 6 months after the first intervention

  • Rate of patients with anastomotic fistula

    from the first intervention to 6 months after the first intervention

  • +4 more secondary outcomes

Study Arms (1)

Study process

EXPERIMENTAL

Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires

Procedure: Pre- and post-operative consultationProcedure: Stomatherapy consultationProcedure: Questionnaires

Interventions

Pre- and post-operative consultationPROCEDURE

Before and between the two interventions

Study process
Stomatherapy consultationPROCEDURE

Clinical exam. At one and six months after the 2nd intervention

Study process
QuestionnairesPROCEDURE

* QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention) * Stoma-QoL before and after the 2nd intervention * LARS score at 1, 3, 6 and 12 months after the 2nd intervention

Study process

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years old
  • Patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis)
  • Already underwent or not a neoadjuvant radio-chemotherapy
  • Affiliation to the National Social Security System
  • With informed and signed consent

You may not qualify if:

  • Unwilling patients
  • Patient deprived of their liberty or under guardianship or tutorship.
  • Abdominal perineal amputation
  • No stoma placement planned
  • Tumor more than 15 cm from the anal margin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

LeadSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetalsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pascale COULON

    Centre Oscar Lambret

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 25, 2017

Study Start

January 18, 2018

Primary Completion

July 29, 2024

Study Completion

July 29, 2024

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)