NCT01682395

Brief Summary

The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

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

First Submitted

Initial submission to the registry

September 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 12, 2017

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

September 6, 2012

Last Update Submit

December 8, 2017

Conditions

Intestinal VolvulusColon, Sigmoid

Keywords

Intestinal volvulusColon, sigmoidAnastomosis, surgicalAnastomotic leakMalawiDeveloping Country

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality within 30 days of surgery, as determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin)per study protocol.

    30-Day

Secondary Outcomes (2)

  • Recurrence of Sigmoid Volvulus

    3 Year

  • Surgical Site Infection

    30-Day

Other Outcomes (2)

  • Anastomotic Leak

    30-Day

  • Stomal Complications

    3 Year

Study Arms (4)

G-SV Resection and colostomy

ACTIVE COMPARATOR

Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis

Procedure: Resection and colostomy

G-SV Resection and anastomosis

EXPERIMENTAL

Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis

Procedure: Resection and anastomosis

NG-SV resection and anastomosis

ACTIVE COMPARATOR

Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis

Procedure: Resection and anastomosis

NG-SV mesosigmoidopexy

EXPERIMENTAL

Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy

Procedure: Mesosigmoidopexy

Interventions

Resection and anastomosisPROCEDURE

Resection of sigmoid colon with primary anastomosis

G-SV Resection and anastomosisNG-SV resection and anastomosis
Resection and colostomyPROCEDURE

Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure

G-SV Resection and colostomy
MesosigmoidopexyPROCEDURE

Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.

NG-SV mesosigmoidopexy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty

You may not qualify if:

  • pregnancy,
  • age under 18 years,
  • prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Related Publications (3)

  • Raveenthiran V, Madiba TE, Atamanalp SS, De U. Volvulus of the sigmoid colon. Colorectal Dis. 2010 Jul;12(7 Online):e1-17. doi: 10.1111/j.1463-1318.2010.02262.x. Epub 2010 Mar 10.

    PMID: 20236153BACKGROUND

  • Akinkuotu A, Samuel JC, Msiska N, Mvula C, Charles AG. The role of the anatomy of the sigmoid colon in developing sigmoid volvulus: a case-control study. Clin Anat. 2011 Jul;24(5):634-7. doi: 10.1002/ca.21131. Epub 2011 Feb 14.

    PMID: 21322064BACKGROUND

  • Samuel JC, Msiska N, Muyco AP, Cairns BA, Charles AG. An observational study addressing the anatomic basis of mesosigmoidopexy as a rational treatment of non-gangrenous sigmoid volvulus. Trop Doct. 2012 Jan;42(1):44-5. doi: 10.1258/td.2011.110317. Epub 2011 Dec 19.

    PMID: 22184737BACKGROUND

Related Links

MeSH Terms

Conditions

Intestinal VolvulusAnastomotic Leak

Interventions

Anastomosis, SurgicalColostomy

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesTorsion AbnormalityPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeEnterostomyDigestive System Surgical ProceduresOstomy

Study Officials

  • Jonathan C Samuel, MD, MPH

    UNC Chapel Hill Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2012

First Posted

September 10, 2012

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 12, 2017

Record last verified: 2015-05

Locations

MA(1)