Patient Reported Outcomes Following Cancer of the Rectum

Rectal Cancer Clinical Trial

— PROCaRe  

Official title:

Patient Reported Outcomes Following Cancer of the Rectum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936581
• Other study ID #: 205/15
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 2028

Study information

• Verified date: January 2024
• Source: University Hospital Gregorio Marañón
• Contact: Patricia Tejedor
• Phone: +34 91 586 7007
• Email: patricia.tejedor[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 45 subjects are necessary in first group and 45 in the second to recognize as statistically significant a difference greater than or equal to 2 units. The common standard deviation is assumed to be

3. It has been anticipated a drop-out rate of 20% Primary outcomes are LARS and Vaizey score. Secondary outcomes included are QLQ C30 and CR29, sexual function questionnaire (female/male), urinary function questionnaire and postoperative complications (Clavien-Dindo classification) Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (September 2021 - September 2023).

It is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in operated patients, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life; Furthermore, there are recent studies that speak of the direct relationship between these factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2028
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Sphincter Ani Incontinence

Intervention

Procedure:
• Open Total Mesorectal Excision
Open approach for Total Mesorectal Excision
• Laparoscopic Total Mesorectal Excision
Laparoscopic approach for Total Mesorectal Excision
• Robotic Total Mesorectal Excision
Robotic approach for Total Mesorectal Excision
• Transanal Total Mesorectal Excision
Transanal approach for Total Mesorectal Excision

Locations

Country	Name	City	State
Spain	University Clinic of Navarre	Madrid
Spain	University Hospital Gregorio Marañón	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Gregorio Marañón	Hospital de Leon, Hospital del Río Hortega, University of Navarrra Hospital (Clinica Universitaria)

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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: — View Citation

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, rando — View Citation

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 — View Citation

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. Colorec — View Citation

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 — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low anterior resection syndrome (LARS) score	LARS score from 0-42 where 0 means better outcomes	2022
Primary	Vaizey score	Incontinence score from 0-28 where 0 means better outcomes	2022
Secondary	QLQ C30	Quality of Life questionnaire	2022
Secondary	QLQ CR29	Quality of life questionnaire, colorectal cancer related	2022
Secondary	Male sexual function	IIEF questionnaire	2022
Secondary	Female sexual function	FSFI questionnaires	2022
Secondary	Urinary function	IPSS questionnaire	2022
Secondary	Postoperative complications	Dindo-Clavien classification	2022