Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

Rectal Cancer Clinical Trial

— QUALIPRO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03292289
• Other study ID #: QUALIPRO-1703
• Secondary ID: 2017-A01406-47
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Groupement Interrégional de Recherche Clinique et d'Innovation, Santelys Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Surgical complications description	Describe surgical complications linked to the coloanal continuity reconstruction	from first intervention to one year after the 2nd intervention
Secondary	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
Secondary	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
Secondary	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