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

Sigmoid Cancer Clinical Trial

— SIG-QOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04729283
• Other study ID #: RC21_0015
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: March 3, 2023

Study information

• Verified date: April 2021
• Source: Nantes University Hospital
• Contact: Emilie DUCHALAIS-DASSONNEVILLE, PH
• Phone: 33240084322
• Email: Emilie.DASSONNEVILLE[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulum
• Sigmoid Cancer
• Sigmoid Diverticulosis
• Sigmoid Neoplasms

Intervention

Procedure:
• Sigmoidectomy
The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers	Maine-et-Loire
France	Caen University Hospital	Caen	Calvados
France	Vendée Departmental Hospital	La Roche-sur-Yon	Vendée
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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