Sigmoid VolvulusNCT06771349
Treatment of Sigmoid Volvulus
An observational study of Sigmoid Volvulus, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sigmoid Volvulus
- What is being tested?
- sigmoidopexy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Observational
- 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
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Gastrointestinal Surgery, Department of General Surgery, West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: Assessment of Recurrence Rate After Sigmoidopexy for Acute Sigmoid Volvulus
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).
Read the detailed description
Introduction:
Colonic volvulus, a significant cause of large bowel obstruction, occurs when a segment of the colon twists, obstructing normal bowel function. Among the different types of colonic volvulus, acute sigmoid volvulus (SV) is the most common, with a high incidence in certain regions, such as the "twist belt" in Africa, Ethiopia, East Asia, and Australia, where its frequency can exceed 50%. SV frequently presents as either partial or complete bowel obstruction, leading to ischemia, necrosis, and potential perforation if untreated. The morbidity and mortality associated with SV are substantial, particularly in elderly patients. Prompt management is crucial to reduce complications and improve patient outcomes.
Treatment Approaches:
The primary goal of treatment is to relieve the obstruction and address the twisted portion of the colon. The World Society of Emergency Surgery (WSES) recommends endoscopic decompression for patients without signs of severe infection, perforation, or hemodynamic instability. If decompression fails, or if necrosis is present, surgical intervention is necessary. Surgical options include sigmoidopexy, sigmoidectomy, mesenteroplasty, or colostomy. Sigmoidopexy is less invasive but carries a higher risk of recurrence, whereas sigmoidectomy, though more complex, may reduce recurrence and improve long-term survival.
Despite various treatment options, the optimal approach remains unclear due to inconsistencies in the existing literature. This study compares two commonly used surgical methods-sigmoidopexy and sigmoidectomy-to assess their outcomes in terms of SV recurrence, complications, and overall survival.
Methods:
This retrospective study reviewed patients who underwent emergency surgery for acute SV at West China Hospital, Sichuan University, between April 2009 and August 2023. The hospital, a major medical center in Chengdu, China, treats thousands of emergency cases annually. Ethical approval was obtained from the hospital's Ethics Review Board, and informed consent was waived due to the study's retrospective nature.
Inclusion Criteria:
Adults with acute symptoms of intestinal obstruction. Acute SV diagnosis confirmed by CT or surgery. First emergency surgery for acute SV at the hospital.
Exclusion Criteria:
Torsion of parts of the colon other than the sigmoid. Non-surgical management of acute SV or treatment at another institution. Conditions such as bowel perforation or unrelated obstructions. Patients unable to undergo surgery due to poor health.
Primary Outcome:
Recurrence rate of SV after sigmoidopexy or sigmoidectomy.
Secondary Outcomes:
30-day mortality and morbidity, assessed by the Clavien-Dindo classification of complications.
Data Collection:
Data were extracted from the hospital's medical records and supplemented by telephone follow-up with patients or their families. Information collected included:
Demographic details (age, gender, symptoms). Medical history (comorbidities, previous surgeries). ASA score, BMI, surgery details, and post-operative recovery. Surgical duration, hospital stay length, complications, and follow-up data.
Statistical Analysis:
Statistical analysis was conducted using R software (version 4.3.3). Continuous variables were assessed for normal distribution and expressed as means ± standard deviation or medians with ranges. Categorical variables were presented as percentages. For comparing continuous variables, Student's t-test or Mann-Whitney U test was used. For categorical data, Chi-square or Fisher's exact test was applied. A P-value of < 0.05 was considered statistically significant.
- Conditions
- Sigmoid Volvulus
- Being tested
- sigmoidopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sigmoidopexyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| sigmoidopexy group | patients who underwent sigmoidopexy Receives: Procedure: sigmoidopexy | |
| sigmoidectomy group | patients who underwent sigmoidopexy without resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: between April 2009 and August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid VolvulusStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomei Jiang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771349
- Sponsor's protocol ID
- 2023-1601
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Recurrence Rate After Sigmoidopexy for Acute Sigmoid Volvulus
- ClinicalTrials.gov ID
- NCT06771349
- Acronym / sponsor ID
- 2023-1601
- Conditions
- Sigmoid Volvulus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Jan 2025 (actual)
- 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.
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).
Detailed description
Introduction:
Colonic volvulus, a significant cause of large bowel obstruction, occurs when a segment of the colon twists, obstructing normal bowel function. Among the different types of colonic volvulus, acute sigmoid volvulus (SV) is the most common, with a high incidence in certain regions, such as the "twist belt" in Africa, Ethiopia, East Asia, and Australia, where its frequency can exceed 50%. SV frequently presents as either partial or complete bowel obstruction, leading to ischemia, necrosis, and potential perforation if untreated. The morbidity and mortality associated with SV are substantial, particularly in elderly patients. Prompt management is crucial to reduce complications and improve patient outcomes.
Treatment Approaches:
The primary goal of treatment is to relieve the obstruction and address the twisted portion of the colon. The World Society of Emergency Surgery (WSES) recommends endoscopic decompression for patients without signs of severe infection, perforation, or hemodynamic instability. If decompression fails, or if necrosis is present, surgical intervention is necessary. Surgical options include sigmoidopexy, sigmoidectomy, mesenteroplasty, or colostomy. Sigmoidopexy is less invasive but carries a higher risk of recurrence, whereas sigmoidectomy, though more complex, may reduce recurrence and improve long-term survival.
Despite various treatment options, the optimal approach remains unclear due to inconsistencies in the existing literature. This study compares two commonly used surgical methods-sigmoidopexy and sigmoidectomy-to assess their outcomes in terms of SV recurrence, complications, and overall survival.
Methods:
This retrospective study reviewed patients who underwent emergency surgery for acute SV at West China Hospital, Sichuan University, between April 2009 and August 2023. The hospital, a major medical center in Chengdu, China, treats thousands of emergency cases annually. Ethical approval was obtained from the hospital's Ethics Review Board, and informed consent was waived due to the study's retrospective nature.
Inclusion Criteria:
Adults with acute symptoms of intestinal obstruction. Acute SV diagnosis confirmed by CT or surgery. First emergency surgery for acute SV at the hospital.
Exclusion Criteria:
Torsion of parts of the colon other than the sigmoid. Non-surgical management of acute SV or treatment at another institution. Conditions such as bowel perforation or unrelated obstructions. Patients unable to undergo surgery due to poor health.
Primary Outcome:
Recurrence rate of SV after sigmoidopexy or sigmoidectomy.
Secondary Outcomes:
30-day mortality and morbidity, assessed by the Clavien-Dindo classification of complications.
Data Collection:
Data were extracted from the hospital's medical records and supplemented by telephone follow-up with patients or their families. Information collected included:
Demographic details (age, gender, symptoms). Medical history (comorbidities, previous surgeries). ASA score, BMI, surgery details, and post-operative recovery. Surgical duration, hospital stay length, complications, and follow-up data.
Statistical Analysis:
Statistical analysis was conducted using R software (version 4.3.3). Continuous variables were assessed for normal distribution and expressed as means ± standard deviation or medians with ranges. Categorical variables were presented as percentages. For comparing continuous variables, Student's t-test or Mann-Whitney U test was used. For categorical data, Chi-square or Fisher's exact test was applied. A P-value of < 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sigmoidopexy group | – | Procedure: sigmoidopexypatients who underwent sigmoidopexy |
| sigmoidectomy group | – | –patients who underwent sigmoidopexy without resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| sigmoidopexyBoth 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. | Procedure or surgery | sigmoidopexy group |
Primary outcome
To determine the recurrence rate of SV following sigmoidopexy or sigmoidectomy.
Time frame: between April 2009 and August 2023
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%
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 14 Jan 2025.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sigmoid Volvulus, run by West China Hospital at 1 site in China.
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 3 inclusion and 4 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 14 Jan 2025. 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 China. 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?
To determine the recurrence rate of SV following sigmoidopexy or sigmoidectomy. (time frame: between April 2009 and August 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.