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Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

NCT ID: NCT03292289

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2024-07-29

Brief Summary

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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.

Detailed Description

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First of all, an information document will be given to the patients and their consent will be collected. Then, they will be registered through the online eCRF (or by FAX) and a study number will be given to each patient.

The study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. Patient care and following up will proceed as usual. The stomatherapy consultation will be done by a qualified nurse.

Before the 1st intervention (proctectomy):

* Collect of clinical data and disease history
* Quality of life questionnaires (EORTC-QLQ-C30 and CR29)
* Evaluation of LARS score

After the 1st intervention (proctectomy, at month 1):

\- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL

Before the 2nd intervention (coloanal continuity reconstruction):

\- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL

After the 2nd intervention (at month 1, month 3, month 6 and one year):

* at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of postoperative complications
* Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score

Conditions

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Rectal Cancer

Keywords

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proctectomy coloanal continuity reconstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Study process

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

Group Type EXPERIMENTAL

Pre- and post-operative consultation

Intervention Type PROCEDURE

Before and between the two interventions

Stomatherapy consultation

Intervention Type PROCEDURE

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

Questionnaires

Intervention Type PROCEDURE

* 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

Interventions

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Pre- and post-operative consultation

Before and between the two interventions

Intervention Type PROCEDURE

Stomatherapy consultation

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

Intervention Type PROCEDURE

Questionnaires

* 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santelys Association

OTHER

Sponsor Role collaborator

Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascale COULON

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

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Centre Oscar Lambret

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01406-47

Identifier Type: OTHER

Identifier Source: secondary_id

QUALIPRO-1703

Identifier Type: -

Identifier Source: org_study_id