Quality of Life of Patients After Rectal Cancer Resection .

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

22 Participants
are grouped into 2 trial groups
Group A: Patients operated by rectal resection and coloanal anastomosis.
Group B: Patients operated by abdominoperineal amputation.

Trial outcomes

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.

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
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.

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

Secondary outcomes

1

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
2

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
3

Study of specific quality of life

Quality of life questionnaires: \* HAD (Hospital Anxiety and Depression Scale, min = 0, maximum = 42)

Time frame
Baseline
4

Study of specific quality of life

Quality of life questionnaires: \* SF 36 (Short Form-36 Health Survey, min = 0, maximum = 100)

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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