Patient Reported Outcomes Following Cancer of the Rectum

NCT04936581 | Recruiting

• 1 other identifier: 205/15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Sphincter Ani Incontinence; Rectal Cancer

Keywords

rectal cancer; taTME; laparoscopic TME; robotic TME; open TME; low anterior resection syndrome

Outcome Measures

Primary Outcomes (2)

• Low anterior resection syndrome (LARS) score

  LARS score from 0-42 where 0 means better outcomes

  2022

• Vaizey score

  Incontinence score from 0-28 where 0 means better outcomes

  2022

Secondary Outcomes (6)

• QLQ C30

  2022

• QLQ CR29

  2022

• Male sexual function

  2022

• Female sexual function

  2022

• Urinary function

  2022

Study Arms (4)

Open Total Mesorectal Excision

Patients undergoing open low anterior resection

Procedure: Open Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Patients undergoing laparoscopic low anterior resection

Procedure: Laparoscopic Total Mesorectal Excision

Robotic Total Mesorectal Excision

Patients undergoing robotic low anterior resection

Procedure: Robotic Total Mesorectal Excision

Transanal Total Mesorectal Excision

Patients undergoing transanal Total Mesorectal Excision (taTME)

Procedure: Transanal Total Mesorectal Excision

Interventions

Open Total Mesorectal Excision PROCEDURE

Open approach for Total Mesorectal Excision

Open Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision PROCEDURE

Laparoscopic approach for Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Robotic Total Mesorectal Excision PROCEDURE

Robotic approach for Total Mesorectal Excision

Robotic Total Mesorectal Excision

Transanal Total Mesorectal Excision PROCEDURE

Transanal approach for Total Mesorectal Excision

Transanal Total Mesorectal Excision

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants that meet the criteria will be identified in each centre

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Gregorio Marañón: lead
• University of Navarrra Hospital (Clinica Universitaria): collaborator
• Hospital de Leon: collaborator
• Hospital del Rio Hortega: collaborator

Study Sites (2)

University Clinic of Navarre

Madrid, Spain

RECRUITING

University Hospital Gregorio Marañón

Madrid, Spain

RECRUITING

Related Publications (13)

• Bonjer 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 RESULT

• Guillou 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 RESULT

• 2017 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 RESULT

• Kim 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 RESULT

• Park 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 RESULT

• Kim 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.

  PMID: 29460997 RESULT

• Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.

  PMID: 29067426 RESULT

• Andolfi C, Umanskiy K. Appraisal and Current Considerations of Robotics in Colon and Rectal Surgery. J Laparoendosc Adv Surg Tech A. 2019 Feb;29(2):152-158. doi: 10.1089/lap.2018.0571. Epub 2018 Oct 16.

  PMID: 30325690 RESULT

• Sylla P, Rattner DW, Delgado S, Lacy AM. NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance. Surg Endosc. 2010 May;24(5):1205-10. doi: 10.1007/s00464-010-0965-6. Epub 2010 Feb 26.

  PMID: 20186432 RESULT

• Burch J, Taylor C, Wilson A, Norton C. Symptoms affecting quality of life after sphincter-saving rectal cancer surgery: A systematic review. Eur J Oncol Nurs. 2021 Jun;52:101934. doi: 10.1016/j.ejon.2021.101934. Epub 2021 Mar 22.

  PMID: 33845303 RESULT

• Christensen P, Im Baeten C, Espin-Basany E, Martellucci J, Nugent KP, Zerbib F, Pellino G, Rosen H; MANUEL Project Working Group. Management guidelines for low anterior resection syndrome - the MANUEL project. Colorectal Dis. 2021 Feb;23(2):461-475. doi: 10.1111/codi.15517. Epub 2021 Jan 24.

  PMID: 33411977 RESULT

• Li K, He X, Tong S, Zheng Y. Risk factors for sexual dysfunction after rectal cancer surgery in 948 consecutive patients: A prospective cohort study. Eur J Surg Oncol. 2021 Aug;47(8):2087-2092. doi: 10.1016/j.ejso.2021.03.251. Epub 2021 Mar 29.

  PMID: 33832775 RESULT

• Tejedor P, Arredondo J, Pellino G, Pata F, Pastor C; PROCaRe study group. Patient Reported Outcomes following Cancer of the Rectum (PROCaRe): protocol of a prospective multicentre international study. Tech Coloproctol. 2023 Dec;27(12):1345-1350. doi: 10.1007/s10151-023-02865-4. Epub 2023 Sep 28.

  PMID: 37770748 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Tejedor

CONTACT

+34 91 586 7007; patricia.tejedor@hotmail.com

Patricia Tejedor

CONTACT

+34 91 586 7007

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 23, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)