Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer (SIG-QOL)

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.

Study Overview

• Status: Recruiting
• Conditions: Sigmoid Diverticulosis; Sigmoid Cancer
• Intervention / Treatment: Procedure: Sigmoidectomy

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Emilie DUCHALAIS-DASSONNEVILLE, PH; Phone Number: 33240084322; Email: Emilie.DASSONNEVILLE@chu-nantes.fr

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • Recruiting
      • Caen University Hospital
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital
      • Contact: Emilie DUCHALAIS-DASSONNEVILLE, PH; Phone Number: 33240084322; Email: Emilie.DASSONNEVILLE@chu-nantes.fr
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49000
      • Recruiting
      • Angers University Hospital
  • Vendée
    • La Roche-sur-Yon, Vendée, France, 85000
      • Recruiting
      • Vendée Departmental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffered from sigmoid cancer or symptomatic diverticulitis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sigmoidectomy for sigmoid cancer; Sigmoid resection surgery for patients who suffer from sigmoid cancer	Procedure: Sigmoidectomy; The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.
Sigmoidectomy for diverticulitis; Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis	Procedure: Sigmoidectomy; The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2021
• Primary Completion (ANTICIPATED): March 3, 2023
• Study Completion (ANTICIPATED): March 3, 2023

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Diverticulitis; LARS score; Sigmoid cancer; Sigmoidectomy; Functional results
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Sigmoid Diseases; Colonic Neoplasms; Diverticulitis; Diverticulum; Diverticular Diseases; Sigmoid Neoplasms
• Other Study ID Numbers: RC21_0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No