An observational study in Rectal Cancer, sponsored by University Hospital, Grenoble. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by University Hospital, Grenoble · Observational
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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.
2,401 studies on the registry are indexed under Rectal Neoplasms; 588 are open to participants now.
This study's planned enrollment of 22 is below the median of 161 across 498 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →University Hospital, Grenoble is the lead sponsor of 838 studies on the registry; 208 are open to participants now.
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All patients over the age of 18 and presenting a locally advanced non-metastatic cancer of the lower rectum (stage II or stage III), requiring, after neoadjuvant chemoradiotherapy (whatever type), a total excision of the mesorectum followed either by abdominoperineal resection or manual coloanal anastomosis, may be included in the study, after signing the written consent form.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after radiochemotherapy by rectal resection and coloanal anastomosis.
Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after chemoradiotherapy by rectal resection and abdominoperineal amputation.
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.
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)
Time frame: Baseline
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.
Quality of life questionnaire: \* EORTC-QR29 (European organization for Research and Treatment of Cancer, colorectal cancer module, 29 items. min score = 29, max = 116)
Time frame: Baseline
Study of specific quality of life
Quality of life questionnaires: \* EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels, minimum score = 0, maximum = 25)
Time frame: Baseline
Study of specific quality of life
Quality of life questionnaires: \* FACT-C (Functional Assessment of Cancer Therapy - Colorectal, minimum = 0, maximum = 136
Time frame: Baseline
Study of specific quality of life
Quality of life questionnaires: \* HAD (Hospital Anxiety and Depression Scale, min = 0, maximum = 42)
Time frame: Baseline
Study of specific quality of life
Quality of life questionnaires: \* SF 36 (Short Form-36 Health Survey, min = 0, maximum = 100)
Time frame: Baseline
Study of specific quality of life
Quality of life questionnaires: \* Stoma-QOL (Stoma Quality of Life Questionnaire, min = 0, maximum = 100)
Time frame: Baseline
Study of specific quality of life
Quality of life questionnaires: \* LARS (Low Anterior Resection Syndrome, min = 0, max = 42)
Time frame: Baseline
Study of specific quality of life
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)
Time frame: Baseline
Morbidity rate on D90 according to Dindo Clavien - nature of the complications
Severe complication rate (Dindo Clavien ≥ 3)
Time frame: 90 days
Length of a hospital stay
Number of days of hospitalization and hospital stays
Time frame: 30 days
overall survival
Kaplan-Meier curves
Time frame: 3 years
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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