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Completed

NCT Number: NCT01682395

Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

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

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Key information

Conditions

Intestinal Volvulus Anastomotic Leak Colon, Sigmoid Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Torsion Abnormality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kamuzu Central Hospital

Lilongwe, Malawi

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy,
  • age under 18 years,
  • prisoners

Treatment and study plan

Resection and anastomosis

Procedure

Resection of sigmoid colon with primary anastomosis

Resection and colostomy

Procedure

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

Mesosigmoidopexy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Recurrence of Sigmoid Volvulus

    Time frame: 3 Year

    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.

  2. Surgical Site Infection

    Time frame: 30-Day

    Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.

Other outcomes

  1. Anastomotic Leak

    Time frame: 30-Day

    Communication of the intraluminal and extraluminal space ad defined by clinical presence of a fecal fistula or operative determination of breakdown of the anastomosis within 30 days of surgery. Of note the NG-SV mesosigmoidopexy arm will not be included in this outcome as there is no anastomosis.

  2. Stomal Complications

    Time frame: 3 Year

    Stomal complications (necrosis, pain, skin irritation, retraction, prolapse, stenosis, parastomal herniation, ventral hernia at prior stoma incision) within 3 years of surgery. Of note the G-SV Resection and colostomy arm will be the only arm included in this outcome as none of the other arms include a colostomy.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2012
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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