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

• Conditions: Sigmoid Cancer; Sigmoid Diverticulosis
• Interventions: Procedure: Sigmoidectomy

• Registration Number: NCT04729283
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Status Verified: 2021-04
• Study Start: 2021-04-12
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sigmoidectomy for sigmoid cancer	Sigmoidectomy	Sigmoid resection surgery for patients who suffer from sigmoid cancer
Sigmoidectomy for diverticulitis	Sigmoidectomy	Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis

Primary Outcome Measures

Name	Time	Method
LARS score	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 Outcome Measures

Name	Time	Method
GIQLI	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.
IIEF5	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.
Bristol stool chart	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.
ICIQ-FLUTS	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.
SF-36	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.
FSFI	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.
IPSS	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.

Trial Locations

Locations (4)

Vendée Departmental Hospital; 🇫🇷 La Roche-sur-Yon, Vendée, France

Angers University Hospital; 🇫🇷 Angers, Maine-et-Loire, France

Caen University Hospital; 🇫🇷 Caen, Calvados, France

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France