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Completed

NCT Number: NCT04729283

Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between 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.

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Key information

Conditions

Sigmoid Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Sigmoid Diseases Sigmoid Diverticulosis Sigmoid Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Caen, Calvados, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Sigmoidectomy

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Bristol stool chart

    Time frame: At the visit of preoperative

    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.

  2. Bristol stool chart

    Time frame: At the visit of one month

    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.

  3. Bristol stool chart

    Time frame: At the visit of three months

    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.

  4. Bristol stool chart

    Time frame: At the visit of six months

    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.

  5. Bristol stool chart

    Time frame: At the visit of twelve months

    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.

  6. GIQLI

    Time frame: At the visit of preoperative

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

  7. GIQLI

    Time frame: At the visit of one month

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

  8. GIQLI

    Time frame: At the visit of three months

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

  9. GIQLI

    Time frame: At the visit of six months

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

  10. GIQLI

    Time frame: At the visit of twelve months

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

  11. SF-36

    Time frame: At the visit of preoperative

    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.

  12. SF-36

    Time frame: At the visit of one month

    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.

  13. SF-36

    Time frame: At the visit of three months

    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.

  14. SF-36

    Time frame: At the visit of six months

    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.

  15. SF-36

    Time frame: At the visit of twelve months

    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.

  16. FSFI

    Time frame: At the visit of preoperative

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

  17. FSFI

    Time frame: At the visit of one month

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

  18. FSFI

    Time frame: At the visit of three months

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

  19. FSFI

    Time frame: At the visit of six months

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

  20. FSFI

    Time frame: At the visit of twelve months

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

  21. ICIQ-FLUTS

    Time frame: At the visit of preoperative

    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.

  22. ICIQ-FLUTS

    Time frame: At the visit of one month

    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.

  23. ICIQ-FLUTS

    Time frame: At the visit of three months

    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.

  24. ICIQ-FLUTS

    Time frame: At the visit of six months

    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.

  25. ICIQ-FLUTS

    Time frame: At the visit of twelve months

    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.

  26. IPSS

    Time frame: At the visit of preoperative

    Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.

  27. IPSS

    Time frame: At the visit of one month

    Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.

  28. IPSS

    Time frame: At the visit of three months

    Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.

  29. IPSS

    Time frame: At the visit of six months

    Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.

  30. IPSS

    Time frame: At the visit of twelve months

    Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.

  31. IIEF5

    Time frame: At the visit of preoperative

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

  32. IIEF5

    Time frame: At the visit of one month

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

  33. IIEF5

    Time frame: At the visit of three months

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

  34. IIEF5

    Time frame: At the visit of six months

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

  35. IIEF5

    Time frame: At the visit of twelve months

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer

Acronym: SIG-QOL

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2021
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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