Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04729283
Acronym
SIG-QOL
Enrollment
200
Registered
2021-01-28
Start date
2021-04-12
Completion date
2023-03-03
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sigmoid Cancer, Sigmoid Diverticulosis

Keywords

LARS score, Sigmoidectomy, Sigmoid cancer, Diverticulitis, Functional results

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.

Interventions

PROCEDURESigmoidectomy

The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
LARS scoreAt the visit of preoperativeTo measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.

Secondary

MeasureTime frameDescription
GIQLIAt the visit of preoperativeQuality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.
SF-36At the visit of preoperativeGeneral 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.
FSFIAt the visit of preoperativeMeasure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.
Bristol stool chartAt the visit of preoperativeA 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.
IPSSAt the visit of preoperativeQuestionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.
IIEF5At the visit of preoperativeQuestionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.
ICIQ-FLUTSAt the visit of preoperativeQuestionary 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.

Countries

France

Contacts

Primary ContactEmilie DUCHALAIS-DASSONNEVILLE, PH
Emilie.DASSONNEVILLE@chu-nantes.fr33240084322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026