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Clinical Trials/NCT07764120
NCT07764120Not yet recruitingNot Applicable

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

University Hospital, Grenoble0 sites22 target enrollmentStarted: August 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
22
Primary Endpoint
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.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients operated by rectal resection and coloanal anastomosis.

Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after radiochemotherapy by rectal resection and coloanal anastomosis.

Patients operated by abdominoperineal amputation.

Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after chemoradiotherapy by rectal resection and abdominoperineal amputation.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Study of specific quality of life(Baseline)
  • Morbidity rate on D90 according to Dindo Clavien - nature of the complications(90 days)
  • Length of a hospital stay(30 days)
  • overall survival(3 years)

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other
Responsible Party
Sponsor

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