Sphincter Ani IncontinencePROCaReNCT04936581
Patient Reported Outcomes Following Cancer of the Rectum
An observational study of Sphincter Ani Incontinence and Rectal Cancer, run by University Hospital Gregorio Marañón at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sphincter Ani Incontinence, Rectal Cancer
- What is being tested?
- Open Total Mesorectal Excision, Laparoscopic Total Mesorectal Excision and Robotic Total Mesorectal Excision
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2021to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants that meet the criteria will be identified in each centre
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Patricia Tejedor contact
Spain2 sites, 2 recruiting
- Recruiting
University Clinic of Navarre
Madrid
Carlos Pastor
- Recruiting
University Hospital Gregorio Marañón
Madrid
Patricia Tejedor
About this study
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.
Read the detailed 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.
- Conditions
- Sphincter Ani Incontinence, Rectal Cancer
- Being tested
- Open Total Mesorectal Excision, Laparoscopic Total Mesorectal Excision, Robotic Total Mesorectal Excision, Transanal Total Mesorectal Excision
- Keywords
- rectal cancer, taTME, laparoscopic TME, robotic TME, open TME, low anterior resection syndrome
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Total Mesorectal ExcisionProcedure or surgery
Open approach for Total Mesorectal Excision
Laparoscopic Total Mesorectal ExcisionProcedure or surgery
Laparoscopic approach for Total Mesorectal Excision
Robotic Total Mesorectal ExcisionProcedure or surgery
Robotic approach for Total Mesorectal Excision
Transanal Total Mesorectal ExcisionProcedure or surgery
Transanal approach for Total Mesorectal Excision
| Study group | Role | What they receive |
|---|---|---|
| Open Total Mesorectal Excision | Patients undergoing open low anterior resection Receives: Procedure: Open Total Mesorectal Excision | |
| Laparoscopic Total Mesorectal Excision | Patients undergoing laparoscopic low anterior resection Receives: Procedure: Laparoscopic Total Mesorectal Excision | |
| Robotic Total Mesorectal Excision | Patients undergoing robotic low anterior resection Receives: Procedure: Robotic Total Mesorectal Excision | |
| Transanal Total Mesorectal Excision | Patients undergoing transanal Total Mesorectal Excision (taTME) Receives: Procedure: Transanal Total Mesorectal Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low anterior resection syndrome (LARS) score
LARS score from 0-42 where 0 means better outcomes
Measured: 2022
Vaizey score
Incontinence score from 0-28 where 0 means better outcomes
Measured: 2022
Secondary outcomes (6)
QLQ C30
Quality of Life questionnaire
Measured: 2022
QLQ CR29
Quality of life questionnaire, colorectal cancer related
Measured: 2022
Male sexual function
IIEF questionnaire
Measured: 2022
Female sexual function
FSFI questionnaires
Measured: 2022
Urinary function
IPSS questionnaire
Measured: 2022
Postoperative complications
Dindo-Clavien classification
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Sep 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sphincter Ani IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Gregorio Marañón
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarrra Hospital (Clinica Universitaria), Hospital de Leon, Hospital del Rio Hortega
- Responsible party
- Principal investigator, Patricia Tejedor, University Hospital Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936581
- Sponsor's protocol ID
- 205/15
- Acronym
- PROCaRe
- Status last verified
- Jan 2024
- First submitted
- 9 Jun 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25830422Guillou 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.
PubMed 158940982017 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.
PubMed 30255642Kim 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.
PubMed 22434245Park 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.
PubMed 24366278Kim 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.
PubMed 29460997Jayne 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.
PubMed 29067426Andolfi 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.
PubMed 30325690Sylla 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.
PubMed 20186432Burch 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.
PubMed 33845303Christensen 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.
PubMed 33411977Li 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.
PubMed 33832775Tejedor 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.
PubMed 37770748
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes Following Cancer of the Rectum
- ClinicalTrials.gov ID
- NCT04936581
- Acronym / sponsor ID
- PROCaRe / 205/15
- Conditions
- Sphincter Ani Incontinence, Rectal Cancer
- Keywords
- rectal cancer, taTME, laparoscopic TME, robotic TME, open TME, low anterior resection syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Gregorio MarañónUniversity, hospital or other
- Collaborators
- University of Navarrra Hospital (Clinica Universitaria), Hospital de Leon, Hospital del Rio Hortega
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open Total Mesorectal Excision | – | Procedure: Open Total Mesorectal ExcisionPatients undergoing open low anterior resection |
| Laparoscopic Total Mesorectal Excision | – | Procedure: Laparoscopic Total Mesorectal ExcisionPatients undergoing laparoscopic low anterior resection |
| Robotic Total Mesorectal Excision | – | Procedure: Robotic Total Mesorectal ExcisionPatients undergoing robotic low anterior resection |
| Transanal Total Mesorectal Excision | – | Procedure: Transanal Total Mesorectal ExcisionPatients undergoing transanal Total Mesorectal Excision (taTME) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants that meet the criteria will be identified in each centre
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Upper rectal cancer, located above the peritoneal reflection
- Previous radical prostatectomy
- Previous pelvic radiotherapy
- Rectal resection without primary anastomosis
- Intraoperative findings of peritoneal carcinomatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Total Mesorectal ExcisionOpen approach for Total Mesorectal Excision | Procedure or surgery | Open Total Mesorectal Excision |
| Laparoscopic Total Mesorectal ExcisionLaparoscopic approach for Total Mesorectal Excision | Procedure or surgery | Laparoscopic Total Mesorectal Excision |
| Robotic Total Mesorectal ExcisionRobotic approach for Total Mesorectal Excision | Procedure or surgery | Robotic Total Mesorectal Excision |
| Transanal Total Mesorectal ExcisionTransanal approach for Total Mesorectal Excision | Procedure or surgery | Transanal Total Mesorectal Excision |
Primary outcome
Low anterior resection syndrome (LARS) score
Time frame: 2022
LARS score from 0-42 where 0 means better outcomes
Vaizey score
Time frame: 2022
Incontinence score from 0-28 where 0 means better outcomes
6 secondary outcomes
QLQ C30
Time frame: 2022
QLQ CR29
Time frame: 2022
Male sexual function
Time frame: 2022
Female sexual function
Time frame: 2022
Urinary function
Time frame: 2022
Postoperative complications
Time frame: 2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 25830422Bonjer 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.
- Results publication: PubMed 15894098Guillou 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.
- Results publication: PubMed 302556422017 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.
- Results publication: PubMed 22434245Kim 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.
- Results publication: PubMed 24366278Park 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.
- Results publication: PubMed 29460997Kim 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.
- Results publication: PubMed 29067426Jayne 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.
- Results publication: PubMed 30325690Andolfi 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.
- Results publication: PubMed 20186432Sylla 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.
- Results publication: PubMed 33845303Burch 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.
- Results publication: PubMed 33411977Christensen 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.
- Results publication: PubMed 33832775Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Tejedor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sphincter Ani Incontinence and Rectal Cancer, run by University Hospital Gregorio Marañón at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Tejedor (+34 91 586 7007, patricia.tejedor@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low anterior resection syndrome (LARS) score (time frame: 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936581, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.