Intestinal VolvulusNCT01682395
Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
A study testing Resection and anastomosis, Resection and colostomy and Mesosigmoidopexy in people with Intestinal Volvulus and Colon, Sigmoid, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Volvulus, Colon, Sigmoid
- What is being tested?
- Resection and anastomosis, Resection and colostomy and Mesosigmoidopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMalawi
- Study dates
- Feb 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty
Who cannot join
- pregnancy,
- age under 18 years,
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.
Read the detailed description
Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe Malawi with sigmoid volvulus will be eligible for inclusion.
Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous sigmoid volvulus).
- Conditions
- Intestinal Volvulus, Colon, Sigmoid
- Being tested
- Resection and anastomosis, Resection and colostomy, Mesosigmoidopexy
- Keywords
- Intestinal volvulus, Colon, sigmoid, Anastomosis, surgical, Anastomotic leak, Malawi, Developing Country
- Medical subject headings
- Intestinal Volvulus, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection and anastomosisProcedure or surgery
Resection of sigmoid colon with primary anastomosis
Resection and colostomyProcedure or surgery
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
MesosigmoidopexyProcedure or surgery
Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
| Study group | Role | What they receive |
|---|---|---|
| G-SV Resection and colostomy | Active comparator | Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis Receives: Procedure: Resection and colostomy |
| G-SV Resection and anastomosis | Experimental | Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis Receives: Procedure: Resection and anastomosis |
| NG-SV resection and anastomosis | Active comparator | Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis Receives: Procedure: Resection and anastomosis |
| NG-SV mesosigmoidopexy | Experimental | Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy Receives: Procedure: Mesosigmoidopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-Day
Secondary outcomes (2)
Recurrence of Sigmoid Volvulus
Recurrence of sigmoid volvulus confirmed radiologically or operatively within 3 years of surgery. This will be determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin, and if recurrence diagnosed outside of study site contact with the treating physician) per study protocol.
Measured: 3 Year
Surgical Site Infection
Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.
Measured: 30-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal VolvulusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan C Samuel, MD, MPH, Principal investigator, UNC Chapel Hill Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682395
- Sponsor's protocol ID
- 12-1091
- Status last verified
- May 2015
- First submitted
- 6 Sep 2012
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20236153Akinkuotu 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.
PubMed 21322064Samuel 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.
PubMed 22184737
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01682395
- Acronym / sponsor ID
- 12-1091
- Conditions
- Intestinal Volvulus, Colon, Sigmoid
- Keywords
- Intestinal volvulus, Colon, sigmoid, Anastomosis, surgical, Anastomotic leak, Malawi, Developing Country
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.
Detailed description
Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe Malawi with sigmoid volvulus will be eligible for inclusion.
Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous sigmoid volvulus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G-SV Resection and colostomy | Active comparator | Procedure: Resection and colostomyGangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis |
| G-SV Resection and anastomosis | Experimental | Procedure: Resection and anastomosisGangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis |
| NG-SV resection and anastomosis | Active comparator | Procedure: Resection and anastomosisNongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis |
| NG-SV mesosigmoidopexy | Experimental | Procedure: MesosigmoidopexyNongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty
Key exclusion criteria (3 listed)
- pregnancy,
- age under 18 years,
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection and anastomosisResection of sigmoid colon with primary anastomosis | Procedure or surgery | G-SV Resection and anastomosis, NG-SV resection and anastomosis |
| Resection and colostomyResection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure | Procedure or surgery | G-SV Resection and colostomy |
| MesosigmoidopexyMesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length. | Procedure or surgery | NG-SV mesosigmoidopexy |
Primary outcome
Mortality
Time frame: 30-Day
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.
2 secondary outcomes
Recurrence of Sigmoid Volvulus
Time frame: 3 Year
Surgical Site Infection
Time frame: 30-Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Background: PubMed 20236153Raveenthiran 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.
- Background: PubMed 21322064Akinkuotu 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.
- Background: PubMed 22184737Samuel 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.
- Related meta-analysis and systematic review registrationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan C Samuel, MD, MPH principal investigator
UNC Chapel Hill Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resection and anastomosis, Resection and colostomy and Mesosigmoidopexy in people with Intestinal Volvulus and Colon, Sigmoid, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30-Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01682395, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017; AzTrials last refreshed its copy on 6 Nov 2026.