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CompletedNCT04729283SIG-QOLUpdated Sep 1, 2026

Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer

An observational study in Sigmoid Cancer and Sigmoid Diverticulosis, sponsored by Nantes University Hospital. Completed at 4 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
94
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sigmoid Cancer
  • Sigmoid Diverticulosis

Keywords

  • LARS score
  • Sigmoidectomy
  • Sigmoid cancer
  • Diverticulitis
  • Functional results
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suffered from sigmoid cancer or symptomatic diverticulitis

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria :

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
94 participants (actual)
Patient registry
No

Groups and cohorts

  • Sigmoidectomy for sigmoid cancer

    Sigmoid resection surgery for patients who suffer from sigmoid cancer

    Procedure: Sigmoidectomy

  • Sigmoidectomy for diverticulitis

    Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis

    Procedure: Sigmoidectomy

Interventions

  • ProcedureSigmoidectomy

    The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the visit of preoperative

  2. 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.

    Time frame: At the visit of one month

  3. 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.

    Time frame: At the visit of three months

  4. 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.

    Time frame: At the visit of six months

  5. 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.

    Time frame: At the visit of twelve months

Secondary outcomes

  1. 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.

    Time frame: At the visit of preoperative

  2. 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.

    Time frame: At the visit of one month

  3. 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.

    Time frame: At the visit of three months

  4. 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.

    Time frame: At the visit of six months

  5. 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.

    Time frame: At the visit of twelve months

  6. GIQLI

    Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.

    Time frame: At the visit of preoperative

  7. GIQLI

    Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.

    Time frame: At the visit of one month

  8. GIQLI

    Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.

    Time frame: At the visit of three months

  9. GIQLI

    Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.

    Time frame: At the visit of six months

  10. GIQLI

    Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.

    Time frame: At the visit of twelve months

  11. 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.

    Time frame: At the visit of preoperative

  12. 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.

    Time frame: At the visit of one month

  13. 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.

    Time frame: At the visit of three months

  14. 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.

    Time frame: At the visit of six months

  15. 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.

    Time frame: At the visit of twelve months

  16. FSFI

    Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.

    Time frame: At the visit of preoperative

  17. FSFI

    Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.

    Time frame: At the visit of one month

  18. FSFI

    Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.

    Time frame: At the visit of three months

  19. FSFI

    Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.

    Time frame: At the visit of six months

  20. FSFI

    Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.

    Time frame: At the visit of twelve months

  21. 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.

    Time frame: At the visit of preoperative

  22. 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.

    Time frame: At the visit of one month

  23. 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.

    Time frame: At the visit of three months

  24. 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.

    Time frame: At the visit of six months

  25. 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.

    Time frame: At the visit of twelve months

  26. 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.

    Time frame: At the visit of preoperative

  27. 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.

    Time frame: At the visit of one month

  28. 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.

    Time frame: At the visit of three months

  29. 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.

    Time frame: At the visit of six months

  30. 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.

    Time frame: At the visit of twelve months

  31. IIEF5

    Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.

    Time frame: At the visit of preoperative

  32. IIEF5

    Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.

    Time frame: At the visit of one month

  33. IIEF5

    Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.

    Time frame: At the visit of three months

  34. IIEF5

    Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.

    Time frame: At the visit of six months

  35. IIEF5

    Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.

    Time frame: At the visit of twelve months

06

Study locations

4 sites
  • Caen University Hospital
    Caen, Calvados 14000, France
  • Nantes University Hospital
    Nantes, Loire-Atlantique 44093, France
  • Angers University Hospital
    Angers, Maine-et-Loire 49000, France
  • Vendée Departmental Hospital
    La Roche-sur-Yon, Vendée 85000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04729283
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Jan 28, 2021
Start date
Apr 12, 2021
Primary completion
Apr 28, 2025
Completion
Apr 28, 2025
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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