Clinical trial · Observational
Quality of Life of Patients After Rectal Cancer Resection .
Quality of Life at 3 Years of Patients Treated by Abdominoperineal Resection or Rectal Resection and Coloanal Anastomosis for Cancer of the Lower Rectum.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients operated by rectal resection and coloanal anastomosis.
- description
- Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after radiochemotherapy by rectal resection and coloanal anastomosis.
- label
- Patients operated by abdominoperineal amputation.
- description
- Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after chemoradiotherapy by rectal resection and abdominoperineal amputation.
Primary outcomes (2)
- measure
- 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.
- timeFrame
- Baseline
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDGrumann MM, Noack EM, Hoffmann IA, Schlag PM. Comparison of quality of life in patients undergoing abdominoperineal extirpation or anterior resection for rectal cancer. Ann Surg. 2001 Feb;233(2):149-56. doi: 10.1097/00000658-200102000-00001. PMID 11176118
- BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
- BACKGROUNDGujral S, Conroy T, Fleissner C, Sezer O, King PM, Avery KN, Sylvester P, Koller M, Sprangers MA, Blazeby JM; European Organisation for Research and Treatment of Cancer Quality of Life Group. Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer. 2007 Jul;43(10):1564-73. doi: 10.1016/j.ejca.2007.04.005. Epub 2007 May 22. PMID 17521904
- BACKGROUNDPachler J, Wille-Jorgensen P. Quality of life after rectal resection for cancer, with or without permanent colostomy. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004323. doi: 10.1002/14651858.CD004323.pub4. PMID 23235607
- BACKGROUNDSprangers MA, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999 Feb;35(2):238-47. doi: 10.1016/s0959-8049(98)00357-8. PMID 10448266
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390