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NCT Number: NCT07764120

Quality of Life of Patients After Rectal Cancer Resection .

Surgical treatment of cancer of the lower rectum by resection and coloanal anastomosis or abdominoperineal resection in both cases exposes the patient to significant functional digestive sequelae (anal incontinence or permanent stoma), and also to urinary and sexual consequences, which have a major impact on quality of life.

Locally advanced rectal cancers leading to one or the other of these two procedures have practically the same characteristics: always fairly large cancers, located in the distal third of the rectum, in most cases requiring neoadjuvant chemoradiotherapy and a temporary or permanent stoma.

Recent surgical advances and improved adjuvant therapy are increasingly steering patients toward "at all costs" sphincter preservation, sometimes at the expense of quality of life.

Abdominoperineal resection with permanent ostomy is classically believed to have a detrimental effect on quality of life compared with resection and low anastomosis. Very few studies have compared these two procedures in terms of long-term functional results and quality of life. Most of them are small and/or retrospective case series, involve heterogeneous populations, or use questionable methodology.

As randomized patients between sacrifice or preservation of the anus, seem not ethical, the study propose to compare in a prospective single-center study two very close populations of patients presenting advanced cancer of the lower rectum after chemoradiotherapy, treated by abdominoperineal resection or resection and coloanal anastomosis, with the objective to determine long-term quality of life.

Most studies, including the recent prospective one, showed no substantial difference between the two procedures in terms of quality of life or functional difficulties. With the caveat of the biases, sphincter conservation would nevertheless seem that is associated with a better quality of life.The aim of this single-centre retrospective study is to compare the quality of life over more than three years in a population of patients with locally advanced lower rectal cancer who underwent surgery after chemoradiotherapy, either rectal resection and coloanal anastomosis or abdominoperineal amputation.

This study might conclude that one procedure is superior to the other in terms of quality of life and help to choose the best technique, which could lead to substantial changes in the management of advanced cancers of the lower rectum.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years
  • Patient operated on for adenocarcinoma of the lower rectum without metastasis
  • Total mesorectal excision (TME) surgery for cancer
  • Patients who underwent coloanal anastomosis or abdominoperineal amputation, regardless of the method and approach, between January 2005 and December 2021
  • Patients' information and non-opposition

Exclusion criteria

  • Double localisation of colorectal cancer during surgery
  • Resection of another organ due to invasion (T4 tumours)
  • Chemotherapy for recurrence or metastasis during follow-up
  • Surgical complication of coloanal anastomosis requiring permanent stoma

Treatment and study plan

Primary outcomes

  1. Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal.

    Time frame: Baseline

    Quality of life questionnaire:

    • EORTC-QLQ C30 (European organization for Research and Treatment of Cancer, colorectal cancer-specific quality of life questionnaire module. 30 items. min score = 30, max = 126)
  2. Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal.

    Time frame: Baseline

    Quality of life questionnaire:

    • EORTC-QR29 (European organization for Research and Treatment of Cancer, colorectal cancer module, 29 items. min score = 29, max = 116)

Secondary outcomes

  1. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels, minimum score = 0, maximum = 25)
  2. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • FACT-C (Functional Assessment of Cancer Therapy - Colorectal, minimum = 0, maximum = 136
  3. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • HAD (Hospital Anxiety and Depression Scale, min = 0, maximum = 42)
  4. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • SF 36 (Short Form-36 Health Survey, min = 0, maximum = 100)
  5. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • Stoma-QOL (Stoma Quality of Life Questionnaire, min = 0, maximum = 100)
  6. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • LARS (Low Anterior Resection Syndrome, min = 0, max = 42)
  7. Study of specific quality of life

    Time frame: Baseline

    Quality of life questionnaires:

    • EORTC QLQ-ELD14 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Elderly Cancer Patients Module, min = 0, max = 100)
  8. Morbidity rate on D90 according to Dindo Clavien - nature of the complications

    Time frame: 90 days

    Severe complication rate (Dindo Clavien ≥ 3)

  9. Length of a hospital stay

    Time frame: 30 days

    Number of days of hospitalization and hospital stays

  10. overall survival

    Time frame: 3 years

    Kaplan-Meier curves

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid LAURENT

CONTACT

[email protected]

+33 (0)4 76 76 70 79

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Quality of Life at 3 Years of Patients Treated by Abdominoperineal Resection or Rectal Resection and Coloanal Anastomosis for Cancer of the Lower Rectum.

Acronym: QRAAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 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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