NCT04729283

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

January 21, 2021

Last Update Submit

April 27, 2021

Conditions

Sigmoid CancerSigmoid Diverticulosis

Keywords

LARS scoreSigmoidectomySigmoid cancerDiverticulitisFunctional results

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (35)

  • Bristol stool chart

    At the visit of preoperative

  • Bristol stool chart

    At the visit of one month

  • Bristol stool chart

    At the visit of three months

  • Bristol stool chart

    At the visit of six months

  • Bristol stool chart

    At the visit of twelve months

  • +30 more secondary outcomes

Study Arms (2)

Sigmoidectomy for sigmoid cancer

Sigmoid resection surgery for patients who suffer from sigmoid cancer

Procedure: Sigmoidectomy

Sigmoidectomy for diverticulitis

Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis

Procedure: Sigmoidectomy

Interventions

SigmoidectomyPROCEDURE

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

Sigmoidectomy for diverticulitisSigmoidectomy for sigmoid cancer

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffered from sigmoid cancer or symptomatic diverticulitis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Caen University Hospital

Caen, Calvados, 14000, France

RECRUITING

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Angers University Hospital

Angers, Maine-et-Loire, 49000, France

RECRUITING

Vendée Departmental Hospital

La Roche-sur-Yon, Vendée, 85000, France

RECRUITING

MeSH Terms

Conditions

Sigmoid NeoplasmsDiverticulitis

Condition Hierarchy (Ancestors)

Colonic NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigmoid DiseasesDiverticular DiseasesGastroenteritis

Central Study Contacts

Emilie DUCHALAIS-DASSONNEVILLE, PH

CONTACT

33240084322Emilie.DASSONNEVILLE@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 28, 2021

Study Start

April 12, 2021

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)