NCT04746326

Brief Summary

The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 29, 2021

Last Update Submit

February 5, 2021

Conditions

Keywords

diverticulumsurgeryappendicitissigmoid volvuluscaecumdiverticulitis

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with mortality

    mortality

    up to 24 weeks

  • Number of Participants with wound infection

    wound infection

    up to 24 weeks

Study Arms (2)

Conservative treatment

OTHER

Conservative treatment stopping oral intake, intravenous antibiotic therapy.

Other: Conservative treatment

Operative treatment

OTHER

Operative procedure Right hemicolectomy Wedge resection of cecum Diverticulectomy + appendectomy Diverticulectomy Appendectomy + drainage

Procedure: Failure conservative treatmentProcedure: Surgery

Interventions

Surgery was performed in patients who failed conservative treatment.

Operative treatment
SurgeryPROCEDURE

Surgery was performed in patients who had generalized peritonitis and perforation.

Operative treatment

Conservative treatment was performed in patients who had no generalized peritonitis and perforation.

Conservative treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with right colon diverticulitis

You may not qualify if:

  • Left colon diverticulitis
  • Right colon diverticulitis detected incidentally
  • lacking data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, 35180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DiverticulumAppendicitisDiverticulitis

Interventions

Surgical Procedures, OperativeConservative Treatment

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntraabdominal InfectionsInfectionsCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Conservative treatment, Operative treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 9, 2021

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 20, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations