Sigmoid CancerSIG-QOLNCT04729283
Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer
An observational study of Sigmoid Cancer and Sigmoid Diverticulosis, run by Nantes University Hospital at 4 sites in France.
Trial summary
The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sigmoid Cancer, Sigmoid Diverticulosis
- What is being tested?
- Sigmoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Apr 2021to 28 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffered from sigmoid cancer or symptomatic diverticulitis
Who may be able to join
- Adults
- Patients who undergo sigmoidectomy with end to end anastomosis for sigmoid cancer and symptomatic diverticulitis
- Preservation of the left colic angle for upper surgical resection
- Lower surgical resection located < 5cm to the recto-sigmoid junction
Who cannot join
- Minors
- Adults under guardianship
- Protected persons
- Patients who undergo sigmoidectomy without anastomosis (ileostomy or Hartmann surgery)
- Patients who undergo surgery in emergency
- Cancer of recto-sigmoid junction
- Patients who undergo secondarily a stoma
Trial locations and contacts
4 sites in 1 country.
France4 sites
Angers University Hospital
Angers, Maine-et-Loire, 49000
Caen University Hospital
Caen, Calvados, 14000
Vendée Departmental Hospital
La Roche-sur-Yon, Vendée, 85000
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
About this study
Official title: Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer
The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.
Read the detailed description
Rectal resection surgery can lead to numerous complications in term of gastrointestinal results with onset of fecal incontinence or in contrast constipation, and in term of genitourinary results with occurrence of dysuria, erectile dysfunction, or vaginal dryness. The low anterior resection syndrome is defined by the occurrence after rectal resection, of gastrointestinal symptoms like fecal incontinence or stool evacuation difficulties, which affect quality of life, despite conservation of anal sphincter. This syndrome is now well known and used in many countries.
However, there is a lack of data concerning gastrointestinal functional results after sigmoid surgery whether it is for cancer or diverticulitis. Some studies highlighted symptoms persistence in many patients after sigmoidectomy. Lately, the LARS score was used after sigmoidectomy for cancer. This study reveals symptoms of low anterior resection syndrome for 41 % of patients. The correlation between rectal resection and sigmoidectomy could be explain by the resection of the upper part of rectum in case of sigmoidectomy.
The issue of genito-urinary disorders after sigmoidectomy are poorly researched. Previous studies demonstrate a higher risk of erectile disorders after pelvic surgery and especially for cancer.
Currently, there is a lack of data on functional results and quality of life for patients who are going into sigmoid surgery, whether for cancer or diverticulitis. The aim of this longitudinal study is to compare digestive functional outcome, genitourinary outcomes and quality of life in patients who undergo sigmoid resection for diverticulitis and cancer.
- Conditions
- Sigmoid Cancer, Sigmoid Diverticulosis
- Being tested
- Sigmoidectomy
- Keywords
- LARS score, Sigmoidectomy, Sigmoid cancer, Diverticulitis, Functional results
- Medical subject headings
- Sigmoid Neoplasms, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SigmoidectomyProcedure or surgery
The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Sigmoidectomy for sigmoid cancer | Sigmoid resection surgery for patients who suffer from sigmoid cancer Receives: Procedure: Sigmoidectomy | |
| Sigmoidectomy for diverticulitis | Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis Receives: Procedure: Sigmoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS score
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
Measured: At the visit of preoperative
LARS score
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
Measured: At the visit of one month
LARS score
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
Measured: At the visit of three months
LARS score
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
Measured: At the visit of six months
LARS score
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
Measured: At the visit of twelve months
Secondary outcomes (35)
Bristol stool chart
A scale to classify the form of the stools in seven category which indicate constipation or diarrhea in function of the type.
Types 1 and 2 indicate constipation, types 3 and 4 are normal stools, type 5, 6 and 7 indicate diarrhea.
Measured: At the visit of preoperative
Bristol stool chart
A scale to classify the form of the stools in seven category which indicate constipation or diarrhea in function of the type.
Types 1 and 2 indicate constipation, types 3 and 4 are normal stools, type 5, 6 and 7 indicate diarrhea.
Measured: At the visit of one month
Bristol stool chart
A scale to classify the form of the stools in seven category which indicate constipation or diarrhea in function of the type.
Types 1 and 2 indicate constipation, types 3 and 4 are normal stools, type 5, 6 and 7 indicate diarrhea.
Measured: At the visit of three months
Bristol stool chart
A scale to classify the form of the stools in seven category which indicate constipation or diarrhea in function of the type.
Types 1 and 2 indicate constipation, types 3 and 4 are normal stools, type 5, 6 and 7 indicate diarrhea.
Measured: At the visit of six months
Bristol stool chart
A scale to classify the form of the stools in seven category which indicate constipation or diarrhea in function of the type.
Types 1 and 2 indicate constipation, types 3 and 4 are normal stools, type 5, 6 and 7 indicate diarrhea.
Measured: At the visit of twelve months
GIQLI
Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.
Measured: At the visit of preoperative
GIQLI
Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.
Measured: At the visit of one month
GIQLI
Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.
Measured: At the visit of three months
GIQLI
Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.
Measured: At the visit of six months
GIQLI
Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.
Measured: At the visit of twelve months
SF-36
General quality of life score. Described with 8 scaled scores, which are : vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, mental health.
Each scale score is from 0 to 100. The higher the score the less disability.
Measured: At the visit of preoperative
SF-36
General quality of life score. Described with 8 scaled scores, which are : vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, mental health.
Each scale score is from 0 to 100. The higher the score the less disability.
Measured: At the visit of one month
SF-36
General quality of life score. Described with 8 scaled scores, which are : vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, mental health.
Each scale score is from 0 to 100. The higher the score the less disability.
Measured: At the visit of three months
SF-36
General quality of life score. Described with 8 scaled scores, which are : vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, mental health.
Each scale score is from 0 to 100. The higher the score the less disability.
Measured: At the visit of six months
SF-36
General quality of life score. Described with 8 scaled scores, which are : vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, mental health.
Each scale score is from 0 to 100. The higher the score the less disability.
Measured: At the visit of twelve months
FSFI
Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.
Measured: At the visit of preoperative
FSFI
Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.
Measured: At the visit of one month
FSFI
Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.
Measured: At the visit of three months
FSFI
Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.
Measured: At the visit of six months
FSFI
Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.
Measured: At the visit of twelve months
ICIQ-FLUTS
Questionary for evaluating female lower urinary tract symptoms and impact on quality of life.
Score from 0 to 48. The higher the score, the worst the urinary continence.
Measured: At the visit of preoperative
ICIQ-FLUTS
Questionary for evaluating female lower urinary tract symptoms and impact on quality of life.
Score from 0 to 48. The higher the score, the worst the urinary continence.
Measured: At the visit of one month
ICIQ-FLUTS
Questionary for evaluating female lower urinary tract symptoms and impact on quality of life.
Score from 0 to 48. The higher the score, the worst the urinary continence.
Measured: At the visit of three months
ICIQ-FLUTS
Questionary for evaluating female lower urinary tract symptoms and impact on quality of life.
Score from 0 to 48. The higher the score, the worst the urinary continence.
Measured: At the visit of six months
ICIQ-FLUTS
Questionary for evaluating female lower urinary tract symptoms and impact on quality of life.
Score from 0 to 48. The higher the score, the worst the urinary continence.
Measured: At the visit of twelve months
IPSS
Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.
Measured: At the visit of preoperative
IPSS
Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.
Measured: At the visit of one month
IPSS
Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.
Measured: At the visit of three months
IPSS
Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.
Measured: At the visit of six months
IPSS
Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.
Measured: At the visit of twelve months
IIEF5
Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.
Measured: At the visit of preoperative
IIEF5
Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.
Measured: At the visit of one month
IIEF5
Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.
Measured: At the visit of three months
IIEF5
Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.
Measured: At the visit of six months
IIEF5
Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.
Measured: At the visit of twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start12 Apr 2021
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid CancerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729283
- Sponsor's protocol ID
- RC21_0015
- Acronym
- SIG-QOL
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer
- ClinicalTrials.gov ID
- NCT04729283
- Acronym / sponsor ID
- SIG-QOL / RC21_0015
- Conditions
- Sigmoid Cancer, Sigmoid Diverticulosis
- Keywords
- LARS score, Sigmoidectomy, Sigmoid cancer, Diverticulitis, Functional results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 28 Jan 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 aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.
Detailed description
Rectal resection surgery can lead to numerous complications in term of gastrointestinal results with onset of fecal incontinence or in contrast constipation, and in term of genitourinary results with occurrence of dysuria, erectile dysfunction, or vaginal dryness. The low anterior resection syndrome is defined by the occurrence after rectal resection, of gastrointestinal symptoms like fecal incontinence or stool evacuation difficulties, which affect quality of life, despite conservation of anal sphincter. This syndrome is now well known and used in many countries.
However, there is a lack of data concerning gastrointestinal functional results after sigmoid surgery whether it is for cancer or diverticulitis. Some studies highlighted symptoms persistence in many patients after sigmoidectomy. Lately, the LARS score was used after sigmoidectomy for cancer. This study reveals symptoms of low anterior resection syndrome for 41 % of patients. The correlation between rectal resection and sigmoidectomy could be explain by the resection of the upper part of rectum in case of sigmoidectomy.
The issue of genito-urinary disorders after sigmoidectomy are poorly researched. Previous studies demonstrate a higher risk of erectile disorders after pelvic surgery and especially for cancer.
Currently, there is a lack of data on functional results and quality of life for patients who are going into sigmoid surgery, whether for cancer or diverticulitis. The aim of this longitudinal study is to compare digestive functional outcome, genitourinary outcomes and quality of life in patients who undergo sigmoid resection for diverticulitis and cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigmoidectomy for sigmoid cancer | – | Procedure: SigmoidectomySigmoid resection surgery for patients who suffer from sigmoid cancer |
| Sigmoidectomy for diverticulitis | – | Procedure: SigmoidectomySigmoid resection surgery for patients who suffer from symptomatic diverticulitis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffered from sigmoid cancer or symptomatic diverticulitis
Key inclusion criteria (4 listed)
- Adults
- Patients who undergo sigmoidectomy with end to end anastomosis for sigmoid cancer and symptomatic diverticulitis
- Preservation of the left colic angle for upper surgical resection
- Lower surgical resection located < 5cm to the recto-sigmoid junction
Key exclusion criteria (7 listed)
- Minors
- Adults under guardianship
- Protected persons
- Patients who undergo sigmoidectomy without anastomosis (ileostomy or Hartmann surgery)
- Patients who undergo surgery in emergency
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 |
|---|---|---|
| SigmoidectomyThe sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis. | Procedure or surgery | Sigmoidectomy for diverticulitis, Sigmoidectomy for sigmoid cancer |
Primary outcome
LARS score
Time frame: At the visit of preoperative
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
LARS score
Time frame: At the visit of one month
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
LARS score
Time frame: At the visit of three months
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
LARS score
Time frame: At the visit of six months
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
LARS score
Time frame: At the visit of twelve months
To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.
35 secondary outcomes
Bristol stool chart
Time frame: At the visit of preoperative
Bristol stool chart
Time frame: At the visit of one month
Bristol stool chart
Time frame: At the visit of three months
Bristol stool chart
Time frame: At the visit of six months
Bristol stool chart
Time frame: At the visit of twelve months
GIQLI
Time frame: At the visit of preoperative
GIQLI
Time frame: At the visit of one month
GIQLI
Time frame: At the visit of three months
GIQLI
Time frame: At the visit of six months
GIQLI
Time frame: At the visit of twelve months
SF-36
Time frame: At the visit of preoperative
SF-36
Time frame: At the visit of one month
SF-36
Time frame: At the visit of three months
SF-36
Time frame: At the visit of six months
SF-36
Time frame: At the visit of twelve months
FSFI
Time frame: At the visit of preoperative
FSFI
Time frame: At the visit of one month
FSFI
Time frame: At the visit of three months
FSFI
Time frame: At the visit of six months
FSFI
Time frame: At the visit of twelve months
ICIQ-FLUTS
Time frame: At the visit of preoperative
ICIQ-FLUTS
Time frame: At the visit of one month
ICIQ-FLUTS
Time frame: At the visit of three months
ICIQ-FLUTS
Time frame: At the visit of six months
ICIQ-FLUTS
Time frame: At the visit of twelve months
IPSS
Time frame: At the visit of preoperative
IPSS
Time frame: At the visit of one month
IPSS
Time frame: At the visit of three months
IPSS
Time frame: At the visit of six months
IPSS
Time frame: At the visit of twelve months
IIEF5
Time frame: At the visit of preoperative
IIEF5
Time frame: At the visit of one month
IIEF5
Time frame: At the visit of three months
IIEF5
Time frame: At the visit of six months
IIEF5
Time frame: At the visit of twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sigmoid Cancer and Sigmoid Diverticulosis, run by Nantes University Hospital at 4 sites in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARS score (time frame: At the visit of preoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.