NCT06771349

Brief Summary

Colonic volvulus, where part of the colon twists, is a significant cause of large bowel obstruction, representing 15% of cases, second only to cancer and diverticulitis. Acute sigmoid volvulus (SV), which affects the sigmoid colon, is the most common type, with morbidity rates ranging from 6% to 42% and mortality varying from 7% to 90%. The incidence of SV varies globally, being more common in regions such as Africa, Ethiopia, Australia, and East Asia, where it can account for up to 50% of bowel obstructions. SV often presents as partial or complete obstruction and can lead to severe complications such as ischemia, necrosis, and perforation, especially in older patients. The primary treatment goals are relieving the obstruction, reducing pressure, and correcting the twist. According to the World Society of Emergency Surgery (WSES), endoscopic decompression is recommended for patients without infection, perforation, or hemodynamic instability. However, surgery is necessary if decompression fails, with options including sigmoidopexy, sigmoidectomy, or colostomy. Sigmoidopexy is less invasive but has a higher recurrence rate, while sigmoidectomy, though riskier, may reduce recurrence and improve long-term survival. This retrospective study aims to compare the outcomes of sigmoidopexy and sigmoidectomy in patients with acute SV undergoing emergency surgery at West China Hospital, Sichuan University, over a 14-year period. The primary outcome is the recurrence rate of SV, with secondary outcomes including 30-day mortality and morbidity (complications).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 8, 2025

Last Update Submit

January 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the recurrence rate of SV following sigmoidopexy or sigmoidectomy.

    The recurrence rate is the number of cases in which a patient has a recurrent torsion of the sigmoid colon after surgical treatment, as a proportion of all patients who undergo surgical treatment, and is usually calculated by the following equation: Recurrence rate = the number of patients with recurrence of sigmoid volvulus after surgery /the total number of patients who underwent surgery ×100%

    between April 2009 and August 2023

Study Arms (2)

sigmoidopexy group

patients who underwent sigmoidopexy

Procedure: sigmoidopexy

sigmoidectomy group

patients who underwent sigmoidopexy without resection

Interventions

sigmoidopexyPROCEDURE

Both Sigmoidectomy and sigmoidopexy can be used for the treatment of sigmoid volvulus. The former is the treatment of sigmoid volvulus by removing a portion of the sigmoid colon, and depending on the patient's condition, a bowel reconstruction or anastomosis may be performed to reattach the healthy bowel segment. The procedure may result in long-term bowel changes and may even require an stomy. sigmoidopexy is a procedure that immobilizes the sigmoid colon to the abdominal wall or pelvic structure, preventing it from twisting again. The goal of sigmoidectomy is primarily to remove damaged or necrotic portions of the sigmoid colon and to treat complications resulting from sigmoid volvulus, especially when the volvulus results in intestinal necrosis, ischemia, or other serious complications. The goal of sigmoidopexy is to prevent the sigmoid from re-twisting by immobilizing the sigmoid, and it is suitable for those cases of sigmoid torsion without severe ischemia or necrosis.

sigmoidopexy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes adult patients (≥18 years) who underwent emergency surgery for acute sigmoid volvulus (SV) at West China Hospital, Sichuan University, between April 2009 and August 2023. Inclusion criteria: (1) Adults presenting with acute intestinal obstruction symptoms, (2) Confirmed diagnosis of acute SV via CT imaging (whirl sign) or intraoperative findings, (3) First emergency surgery for acute SV, either sigmoidopexy or sigmoidectomy. Exclusion criteria: (1) Torsion of bowel segments other than the sigmoid colon, (2) Prior conservative or surgical treatment for acute SV at another institution, (3) Concurrent bowel conditions unrelated to SV (e.g., perforation), (4) Severe comorbidities unfit for surgery. Patients who met all inclusion criteria and none of the exclusion criteria were included in the study.

You may qualify if:

  • Adult patients presenting with symptoms of acute intestinal obstruction.
  • Diagnosis of acute SV confirmed by the typical "whirl sign" on computed tomography (CT) or laparotomy.
  • First emergency surgery for acute SV performed at our institution.

You may not qualify if:

  • Torsion of intestinal segments other than the sigmoid.
  • Patients diagnosed with "acute SV" but treated conservatively or operated on at another hospital.
  • Concurrent conditions such as non-SV-related bowel perforation or obstruction.
  • Patients with severe overall states not amenable to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastrointestinal Surgery, Department of General Surgery, West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 13, 2025

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared publicly. However, upon request, the corresponding author can provide access to the data for specific research purposes, subject to approval.

Locations