Clinical trial · Observational
Patient Reported Outcomes Following Cancer of the 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)
The surgical management of rectal cancer includes a Total Mesorectal Excison (TME); depending on the height of the tumor, the problem of preservation of the anal sphincter arises, being able to perform a low anterior resection, an ultra-low anterior resection (RAUB) or an intersphincteric dissection. In some cases invading the sphincters or the puborectalis muscle, an abdominoperineal resection needs to be performed, being the gold standard in this particular situation so far. TME can be performed by open, laparoscopic, robotic or transanal approaches, as long as the oncological principles for the resection are achieved. Unfortunately, up to 90% of these patients will present a change in bowel habit, ranging from an increased frequency of bowel movements to the degree of fecal incontinence or evacuation dysfunction. Of these patients, 25-50% will have a severe alteration in the quality of life. This wide spectrum of symptoms has been called "low anterior resection syndrome" (LARS). Other collateral damage is the change in sexual and urinary function, due to hypogastric plexus injury. There is a significant lack of multicenter prospective studies that provide evidence, and that reveal the functional results and quality of life of these techniques available to date for the management of rectal cancer. The study is set up as a prospective multicentre observational study. Inclusion criteria are: 1) patients over 18 years old, 2) diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/without derivative stoma and 5) with/without neoadjuvant treatment. Exclusion criteria are: 1) Upper rectal cancer, located above the peritoneal reflection, 2) previous radical prostatectomy, 3) previous pelvic radiotherapy, 4) rectal resection without primary anastomosis, 5) intraoperative findings of peritoneal carcinomatosis, 6) stage IV disease, 7) multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder, 8) rectal resection due to a benign condition, 9) rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm), 10) rectal resection following a 'watch \& wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease.
Conditions
Conditions (2)
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 |
| Sphincter Ani Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Total Mesorectal Excision | Procedure | — | UNRESOLVED |
| Open Total Mesorectal Excision | Procedure | — | UNRESOLVED |
| Robotic Total Mesorectal Excision | Procedure | — | UNRESOLVED |
| Transanal Total Mesorectal Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Open Total Mesorectal Excision
- description
- Patients undergoing open low anterior resection
- interventionNames
- Procedure: Open Total Mesorectal Excision
- label
- Laparoscopic Total Mesorectal Excision
- description
- Patients undergoing laparoscopic low anterior resection
- interventionNames
- Procedure: Laparoscopic Total Mesorectal Excision
- label
- Robotic Total Mesorectal Excision
- description
- Patients undergoing robotic low anterior resection
- interventionNames
- Procedure: Robotic Total Mesorectal Excision
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years old * Informed consent * Diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI * Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches * Patients with/without derivative stoma * Patients with/without neoadjuvant treatment Exclusion Criteria: * Upper rectal cancer, located above the peritoneal reflection * Previous radical prostatectomy * Previous pelvic radiotherapy * Rectal resection without primary anastomosis * Intraoperative findings of peritoneal carcinomatosis * Stage IV disease * Multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder * Rectal resection due to a benign condition * Rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm) * Rectal resection following a 'watch \& wait' program * Emergency surgery * Previous derivative colostomy * Inflammatory bowel disease
References
Publications (13)
- RESULTBonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882. PMID 25830422
- RESULTGuillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2. PMID 15894098
- RESULT2017 European Society of Coloproctology (ESCP) collaborating group. An international multicentre prospective audit of elective rectal cancer surgery; operative approach versus outcome, including transanal total mesorectal excision (TaTME). Colorectal Dis. 2018 Sep;20 Suppl 6:33-46. doi: 10.1111/codi.14376. PMID 30255642
- RESULTKim JY, Kim NK, Lee KY, Hur H, Min BS, Kim JH. A comparative study of voiding and sexual function after total mesorectal excision with autonomic nerve preservation for rectal cancer: laparoscopic versus robotic surgery. Ann Surg Oncol. 2012 Aug;19(8):2485-93. doi: 10.1245/s10434-012-2262-1. Epub 2012 Mar 21. PMID 22434245
- RESULTPark SY, Choi GS, Park JS, Kim HJ, Ryuk JP, Yun SH. Urinary and erectile function in men after total mesorectal excision by laparoscopic or robot-assisted methods for the treatment of rectal cancer: a case-matched comparison. World J Surg. 2014 Jul;38(7):1834-42. doi: 10.1007/s00268-013-2419-5. PMID 24366278
- RESULTKim HJ, Choi GS, Park JS, Park SY, Yang CS, Lee HJ. The impact of robotic surgery on quality of life, urinary and sexual function following total mesorectal excision for rectal cancer: a propensity score-matched analysis with laparoscopic surgery. Colorectal Dis. 2018 May;20(5):O103-O113. doi: 10.1111/codi.14051.