Clinical trial NCT04729283: Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer
Official title: Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sigmoid Cancer
Sigmoid Diverticulosis
Keywords: LARS score
Sigmoidectomy
Sigmoid cancer
Diverticulitis
Functional results
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffered from sigmoid cancer or symptomatic diverticulitis

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.

Eligibility criteria: 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

Primary outcomes:
measure: LARS score
timeFrame: At the visit of preoperative
measure: LARS score
timeFrame: At the visit of one month
measure: LARS score
timeFrame: At the visit of three months
measure: LARS score
timeFrame: At the visit of six months
measure: LARS score
timeFrame: At the visit of twelve months
Secondary outcomes:
measure: Bristol stool chart
timeFrame: At the visit of preoperative
measure: Bristol stool chart
timeFrame: At the visit of one month
measure: Bristol stool chart
timeFrame: At the visit of three months
measure: Bristol stool chart
timeFrame: At the visit of six months
measure: Bristol stool chart
timeFrame: At the visit of twelve months
measure: GIQLI
timeFrame: At the visit of preoperative
measure: GIQLI
timeFrame: At the visit of one month
measure: GIQLI
timeFrame: At the visit of three months
measure: GIQLI
timeFrame: At the visit of six months
measure: GIQLI
timeFrame: At the visit of twelve months
measure: SF-36
timeFrame: At the visit of preoperative
measure: SF-36
timeFrame: At the visit of one month
measure: SF-36
timeFrame: At the visit of three months
measure: SF-36
timeFrame: At the visit of six months
measure: SF-36
timeFrame: At the visit of twelve months
measure: FSFI
timeFrame: At the visit of preoperative
measure: FSFI
timeFrame: At the visit of one month
measure: FSFI
timeFrame: At the visit of three months
measure: FSFI
timeFrame: At the visit of six months
measure: FSFI
timeFrame: At the visit of twelve months
measure: ICIQ-FLUTS
timeFrame: At the visit of preoperative
measure: ICIQ-FLUTS
timeFrame: At the visit of one month
measure: ICIQ-FLUTS
timeFrame: At the visit of three months
measure: ICIQ-FLUTS
timeFrame: At the visit of six months
measure: ICIQ-FLUTS
timeFrame: At the visit of twelve months
measure: IPSS
timeFrame: At the visit of preoperative
measure: IPSS
timeFrame: At the visit of one month
measure: IPSS
timeFrame: At the visit of three months
measure: IPSS
timeFrame: At the visit of six months
measure: IPSS
timeFrame: At the visit of twelve months
measure: IIEF5
timeFrame: At the visit of preoperative
measure: IIEF5
timeFrame: At the visit of one month
measure: IIEF5
timeFrame: At the visit of three months
measure: IIEF5
timeFrame: At the visit of six months
measure: IIEF5
timeFrame: At the visit of twelve months
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
city: Angers
country: France
facility: Angers University Hospital
state: Maine-et-Loire
city: La Roche-sur-Yon
country: France
facility: Vendée Departmental Hospital
state: Vendée
Study officials:
References: