Colon, Sigmoid, Intestinal Volvulus
Conditions
Keywords
Intestinal volvulus, Colon, sigmoid, Anastomosis, surgical, Anastomotic leak, Malawi, Developing Country
Brief summary
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).
Interventions
PROCEDUREResection and anastomosis
Resection of sigmoid colon with primary anastomosis
PROCEDUREResection and colostomy
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
PROCEDUREMesosigmoidopexy
Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty
Exclusion criteria
* pregnancy, * age under 18 years, * prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Sigmoid Volvulus | 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. |
| Surgical Site Infection | 30-Day | Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic Leak | 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. |
| Stomal Complications | 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. |
Countries
Malawi
Outcome results
None listed