Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction (QUALIPRO)

Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Pre- and post-operative consultation; Procedure: Stomatherapy consultation; Procedure: Questionnaires

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study process; Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires

Procedure: Pre- and post-operative consultation; Before and between the two interventions; Procedure: Stomatherapy consultation; Clinical exam. At one and six months after the 2nd intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life before the first intervention and after the second intervention	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 one year after the 2nd intervention
Quality of life using EORTC-QLQ-C30	Assess the quality of life using EORTC-QLQ-C30 questionnaires before the first intervention, between the first and the second intervention and after the second intervention	from baseline to one year after the 2nd intervention
Quality of life using EORTC-QLQ-CR29 questionnaires	Assess the quality of life using EORTC-QLQ- CR29 questionnaires before the first intervention, between the first and the second intervention and after the second intervention	from baseline to one year after the 2nd intervention
Impact of stomy on quality of life	Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire	from the first intervention to 6 months after the first intervention
Rate of patients with anastomotic fistula	Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction	from the first intervention to 6 months after the first intervention
Surgical complications description	Describe surgical complications linked to the coloanal continuity reconstruction	from first intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires	Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .	From the 2nd intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires	Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .	From the 2nd intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using LARS score	Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .	From the 2nd intervention to one year after the 2nd intervention

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Santelys Association; Groupement Interrégional de Recherche Clinique et d'Innovation
• Investigators: Study Director: Pascale COULON, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Estimated): February 16, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: proctectomy; coloanal continuity reconstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: QUALIPRO-1703; 2017-A01406-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No