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Completed

NCT Number: NCT03292289

Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre- and post-operative consultation

Procedure

Before and between the two interventions

Stomatherapy consultation

Procedure

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

Questionnaires

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

Primary outcomes

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

    Time frame: from baseline to 1 year 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")

Secondary outcomes

  1. Quality of life before the first intervention and after the second intervention

    Time frame: from baseline to one year after the 2nd 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")

  2. Quality of life using EORTC-QLQ-C30

    Time frame: from baseline to one year after the 2nd intervention

    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

  3. Quality of life using EORTC-QLQ-CR29 questionnaires

    Time frame: from baseline to one year after the 2nd intervention

    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

  4. Impact of stomy on quality of life

    Time frame: from the first intervention to 6 months after the first intervention

    Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire

  5. Rate of patients with anastomotic fistula

    Time frame: from the first intervention to 6 months after the first intervention

    Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction

  6. Surgical complications description

    Time frame: from first intervention to one year after the 2nd intervention

    Describe surgical complications linked to the coloanal continuity reconstruction

  7. Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires

    Time frame: From the 2nd intervention to one year after the 2nd intervention

    Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

  8. Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires

    Time frame: From the 2nd intervention to one year after the 2nd intervention

    Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

  9. Quality of life of patients with a second stoma placement, using LARS score

    Time frame: From the 2nd intervention to one year after the 2nd intervention

    Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation
  • Santelys Association

Registry information

Official study title

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

Acronym: QUALIPRO

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2017
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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