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

N

Nantes University Hospital (NUH)

Status

Unknown

Conditions

Sigmoid Cancer
Sigmoid Diverticulosis

Treatments

Procedure: Sigmoidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04729283
RC21_0015

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 2 patient groups

Sigmoidectomy for sigmoid cancer
Description:
Sigmoid resection surgery for patients who suffer from sigmoid cancer
Treatment:
Procedure: Sigmoidectomy
Sigmoidectomy for diverticulitis
Description:
Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis
Treatment:
Procedure: Sigmoidectomy

Trial contacts and locations

4

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Central trial contact

Emilie DUCHALAIS-DASSONNEVILLE, PH

Data sourced from clinicaltrials.gov

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