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

Study Overview
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Brief Summary
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The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

Detailed Description
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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.

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

Conditions
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Sigmoid Cancer, Sigmoid Diverticulosis

Intervention / Treatment
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* Procedure: Sigmoidectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sigmoidectomy for sigmoid cancer<br>Sigmoid resection surgery for patients who suffer from sigmoid cancer | Procedure: Sigmoidectomy<br>* The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.<br>|
| Sigmoidectomy for diverticulitis<br>Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis | Procedure: Sigmoidectomy<br>* The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | At the visit of twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At the visit of twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LARS score, Sigmoidectomy, Sigmoid cancer, Diverticulitis, Functional results