Randomized Controlled Trial of the SurgDiff Model for Predicting Surgical Difficulty to Help Choose Approach in Mid-Low Rectal Cancer
NCT07761169
Colorectal Neoplasms, Digestive System Diseases
View Trial DetailsNCT Number: NCT07764120
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Quality of life questionnaire:
Time frame: Baseline
Quality of life questionnaire:
Time frame: Baseline
Quality of life questionnaires:
Time frame: Baseline
Quality of life questionnaires:
Time frame: Baseline
Quality of life questionnaires:
Time frame: Baseline
Quality of life questionnaires:
Time frame: Baseline
Quality of life questionnaires:
Time frame: Baseline
Quality of life questionnaires:
Time frame: Baseline
Quality of life questionnaires:
Time frame: 90 days
Severe complication rate (Dindo Clavien ≥ 3)
Time frame: 30 days
Number of days of hospitalization and hospital stays
Time frame: 3 years
Kaplan-Meier curves
Contact information is provided by the study sponsor or research team.
University Hospital, Grenoble
Other
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
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