Endoscopic Surgical ProcedureNCT07155304
Percutaneous Sigmoid Fixation For Management Of Recurrent Sigmoid Volvulus
A study testing percutaneous sigmoid colon fixation in people with Endoscopic Surgical Procedure, run by Zagazig University at 1 site in Egypt.
Trial summary
The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Surgical Procedure
- What is being tested?
- percutaneous sigmoid colon fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Aug 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old
Who cannot join
- patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Sigmoid Fixation For Management Of Recurrent Sigmoid Volvulus : A Randomized Controlled Trial
The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). The investigators included patients were of the American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old while excluded patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35. This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 633/1-Sep-2024) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects.
Read the detailed description
The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). The investigators included patients were of the American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old while excluded patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35. This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 633/1-Sep-2024) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects.
Sample size in this study was calculated based on comparison of mortality rate after endoscopy and surgical procedure in elderly patients with sigmoid volvulus as primary outcome for this study. Prior data from (Jackson et al., 2020) revealed that mortality rate after surgical intervention was 16-42% and after percutaneous fixation was 9.7%. So, using power and sample size calculator we included 33 patients in the surgical group and 33 patients in the percutaneous group to be able to reject the null hypothesis that mortality rates for both groups' subjects were equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis was 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Dropout rate was 20%.
Primary outcome was recurrence of the sigmoid volvulus while the secondary outcomes were mortality rate , complications and hospital stay in each group after the intervention during the 3-months follow-up period, respectively.
Follow up after endoscopy and discharge from the hospital All patients were clinically examined, and laboratory checked during the hospital stay. Any suspected gastric leak post repair mandated CT scan with oral and I.V contrast and upper GI endoscopy. After discharge, patients who had undergone balloon dilation as a part of their repair procedure were scoped every 4 weeks to continue the dilation till relief of distal pouch narrowing. Patients were followed-up for at least 3 months post repair.
Statistical analysis Analysis of data was performed using SPSS (Statistical Package of Social Services) version 22. Quantitative variables were described as mean (±SD, standard deviation) and median (range) according to Shapiro test of normality. Qualitative variables were described as number and percentage. Chi-square test was used to compare qualitative variables between the 2 groups. Fisher exact test was used when one expected cell or more are less than 5. Unpaired t-test was used to compare quantitative variables, in parametric data (SD < 30% of the mean). Mann Whitney test was used instead of unpaired t-test in non-parametric data (SD > 30% of the mean). The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).
- Conditions
- Endoscopic Surgical Procedure
- Being tested
- percutaneous sigmoid colon fixation
- Keywords
- endoscopy, volvulus,
- Medical subject headings
- Intestinal Volvulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous sigmoid colon fixationProcedure or surgery
after endoscopic sigmoid colon untwisting , percutaneous colon fixation using anchor device
| Study group | Role | What they receive |
|---|---|---|
| percutaneous group | Active comparator | percutaneous fixation of sigmoid volvulus after endoscopic untwisting to prevent recurrence using anchor device Receives: Procedure: percutaneous sigmoid colon fixation |
| surgical group | No intervention | surgical management of sigmoid volvulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of recurrence of volvulus
incidence of recurrence of volvulus
Measured: within one week after the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Aug 2024
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Model description
- The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). Sample size in this study was calculated based on comparison of mortality rate after endoscopy and surgical procedure in elderly patients with sigmoid volvulus as primary outcome for this study. Prior data from (Jackson et al., 2020) revealed that mortality rate after surgical intervention was 16-42% and after percutaneous fixation was 9.7%. So, using power and sample size calculator we included 33 patients in the surgical group(group1) and 33 patients in the percutaneous group (group2) to be able to reject the null hypothesis that mortality rates for both groups' subjects were equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis was 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Dropout rate was 20%.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Said Mohamed Said Abdou Negm, Zagazig University
- Investigators
- Said Mohamed Negm, M.D, Principal investigator, Zagazig University Faculty Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155304
- Sponsor's protocol ID
- Mahmoud Alballat
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Negm S, AboZeid AK, Shafiq A, Awad JRI, Nawar A, Wassef PNA, Abdelghan AA, Saleh MA, Elballat MR, Elhendawey E, Mahgoub AM, Mohamed AB, Bayomi MS, Faid AA, Fathy KM, Farag A. Percutaneous sigmoid fixation for management of recurrent sigmoid volvulus: a randomized controlled clinical trial. World J Emerg Surg. 2026 May 20;21(1):34. doi: 10.1186/s13017-026-00701-2.
PubMed 42163400
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Sigmoid Fixation For Management Of Recurrent Sigmoid Volvulus : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07155304
- Acronym / sponsor ID
- Mahmoud Alballat
- Conditions
- Endoscopic Surgical Procedure
- Keywords
- endoscopy, volvulus,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 4 Sep 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.
The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). The investigators included patients were of the American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old while excluded patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35. This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 633/1-Sep-2024) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects.
Detailed description
The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). The investigators included patients were of the American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old while excluded patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35. This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 633/1-Sep-2024) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects.
Sample size in this study was calculated based on comparison of mortality rate after endoscopy and surgical procedure in elderly patients with sigmoid volvulus as primary outcome for this study. Prior data from (Jackson et al., 2020) revealed that mortality rate after surgical intervention was 16-42% and after percutaneous fixation was 9.7%. So, using power and sample size calculator we included 33 patients in the surgical group and 33 patients in the percutaneous group to be able to reject the null hypothesis that mortality rates for both groups' subjects were equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis was 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Dropout rate was 20%.
Primary outcome was recurrence of the sigmoid volvulus while the secondary outcomes were mortality rate , complications and hospital stay in each group after the intervention during the 3-months follow-up period, respectively.
Follow up after endoscopy and discharge from the hospital All patients were clinically examined, and laboratory checked during the hospital stay. Any suspected gastric leak post repair mandated CT scan with oral and I.V contrast and upper GI endoscopy. After discharge, patients who had undergone balloon dilation as a part of their repair procedure were scoped every 4 weeks to continue the dilation till relief of distal pouch narrowing. Patients were followed-up for at least 3 months post repair.
Statistical analysis Analysis of data was performed using SPSS (Statistical Package of Social Services) version 22. Quantitative variables were described as mean (±SD, standard deviation) and median (range) according to Shapiro test of normality. Qualitative variables were described as number and percentage. Chi-square test was used to compare qualitative variables between the 2 groups. Fisher exact test was used when one expected cell or more are less than 5. Unpaired t-test was used to compare quantitative variables, in parametric data (SD < 30% of the mean). Mann Whitney test was used instead of unpaired t-test in non-parametric data (SD > 30% of the mean). The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). Sample size in this study was calculated based on comparison of mortality rate after endoscopy and surgical procedure in elderly patients with sigmoid volvulus as primary outcome for this study. Prior data from (Jackson et al., 2020) revealed that mortality rate after surgical intervention was 16-42% and after percutaneous fixation was 9.7%. So, using power and sample size calculator we included 33 patients in the surgical group(group1) and 33 patients in the percutaneous group (group2) to be able to reject the null hypothesis that mortality rates for both groups' subjects were equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis was 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Dropout rate was 20%.
| Arm | Type | Receives |
|---|---|---|
| percutaneous group | Active comparator | Procedure: percutaneous sigmoid colon fixationpercutaneous fixation of sigmoid volvulus after endoscopic untwisting to prevent recurrence using anchor device |
| surgical group | No intervention | –surgical management of sigmoid volvulus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old
Key exclusion criteria (1 listed)
- patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35
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 |
|---|---|---|
| percutaneous sigmoid colon fixationafter endoscopic sigmoid colon untwisting , percutaneous colon fixation using anchor device | Procedure or surgery | percutaneous group |
Primary outcome
incidence of recurrence of volvulus
Time frame: within one week after the endoscopy
incidence of recurrence of volvulus
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 4 Sep 2025.
- Derived from this study: PubMed 42163400Negm S, AboZeid AK, Shafiq A, Awad JRI, Nawar A, Wassef PNA, Abdelghan AA, Saleh MA, Elballat MR, Elhendawey E, Mahgoub AM, Mohamed AB, Bayomi MS, Faid AA, Fathy KM, Farag A. Percutaneous sigmoid fixation for management of recurrent sigmoid volvulus: a randomized controlled clinical trial. World J Emerg Surg. 2026 May 20;21(1):34. doi: 10.1186/s13017-026-00701-2.
- Individual participant dataSharing planned: Undecided
Related trials for Endoscopic Surgical Procedure
Recruiting
Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
Fospropofol Disodium
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
Not yet recruiting
27-Inch Versus 55-Inch Monitors in Women Undergoing Endometrial Cancer Surgery
Endometrial Cancer
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
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.
Said Mohamed Negm, M.D principal investigator
Zagazig University Faculty Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous sigmoid colon fixation in people with Endoscopic Surgical Procedure, run by Zagazig University at 1 site in Egypt.
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 1 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 4 Sep 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 Egypt. 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?
incidence of recurrence of volvulus (time frame: within one week after the endoscopy). 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 NCT07155304, which also lists 1 linked publication.
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 4 Sep 2025.