Metabolic SurgeryNCT07348146
Hand-Sewn vs. Stapled Anastomosis in SADI-S: Early Postoperative Complications.
A study testing Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) and Stapled Single Anastomosis Duodena-ileal Sleeve in people with Metabolic Surgery and Obesity & Overweight, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Surgery, Obesity & Overweight
- What is being tested?
- Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) and Stapled Single Anastomosis Duodena-ileal Sleeve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70
- Patients who will undergo SADI-S surgery
Who cannot join
- Patients with severe medical conditions such as heart failure and interstitial lung disease.
- Patients with short bowel
- Patients with severe GERD
- Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements
- Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hand-Sewn vs. Stapled Anastomosis in SADI-S: A Prospective Randomized Trial of Early Postoperative Complications.
This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II).
- Conditions
- Metabolic Surgery, Obesity & Overweight
- Being tested
- Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S), Stapled Single Anastomosis Duodena-ileal Sleeve
- Keywords
- Stapled versus Hand-sewn Technique, SADI-s, Metabolic Bariatric Surgery
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)Procedure or surgery
Arm 1 - Hand-sewn Duodeno-Ileal Anastomosis Following sleeve gastrectomy, a hand-sewn duodeno-ileal anastomosis is performed in two layers, with the inner layer constructed using absorbable barbed sutures and the outer reinforcing layer using absorbable monofilament sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.
Stapled Single Anastomosis Duodena-ileal SleeveProcedure or surgery
Arm 2 - Stapled Single Anastomosis Duodena-ileal Sleeve Following sleeve gastrectomy, a stapled duodeno-ileal anastomosis is created using endoscopic linear stapling devices, followed by closure of the enterotomy in a single layer using absorbable barbed sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.
| Study group | Role | What they receive |
|---|---|---|
| Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) | Active comparator | Not described Receives: Procedure: Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) |
| Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) | Active comparator | Not described Receives: Procedure: Stapled Single Anastomosis Duodena-ileal Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Injury
Measured: One month after surgery
Anastomotic Leak Rate
Measured: one month after the surgery
Post operative Bleeding
Measured: One month after surgery
Anastomotic Stircture
Measured: Six months after surgery
Operative Time
Measured: Immediately after surgery
Secondary outcomes (2)
Weight loss
Measured: Six months after surgery
Length of Hosptial Stay
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolic SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam M, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348146
- Sponsor's protocol ID
- Stapled SADIs 082025
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kshirsagar VV, Mp H. A Comparative Study of Hand-Sewn and Stapled Anastomosis in Gastrointestinal Surgeries. Cureus. 2024 Oct 11;16(10):e71264. doi: 10.7759/cureus.71264. eCollection 2024 Oct.
PubMed 39525136Ebinuma S, Kunisawa S, Fushimi K, Ichikawa N, Yoshida T, Homma S, Taketomi A, Imanaka Y. Comparative retrospective study on surgical outcomes of hand-sewn anastomosis versus stapling anastomosis for colectomy using a nationwide inpatient database in Japan with propensity score matching. Ann Gastroenterol Surg. 2024 Oct 11;9(2):379-388. doi: 10.1002/ags3.12870. eCollection 2025 Mar.
PubMed 40046528Pennestri F, Sessa L, Prioli F, Salvi G, Gallucci P, Ciccoritti L, Greco F, De Crea C, Raffaelli M. Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. Langenbecks Arch Surg. 2022 Aug;407(5):1851-1862. doi: 10.1007/s00423-022-02501-z. Epub 2022 Mar 29.
PubMed 35352174O'Brien PE, Hindle A, Brennan L, Skinner S, Burton P, Smith A, Crosthwaite G, Brown W. Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding. Obes Surg. 2019 Jan;29(1):3-14. doi: 10.1007/s11695-018-3525-0.
PubMed 30293134Lazzati A, Bechet S, Jouma S, Paolino L, Jung C. Revision surgery after sleeve gastrectomy: a nationwide study with 10 years of follow-up. Surg Obes Relat Dis. 2020 Oct;16(10):1497-1504. doi: 10.1016/j.soard.2020.05.021. Epub 2020 May 29.
PubMed 32636173Aleassa EM, Hassan M, Hayes K, Brethauer SA, Schauer PR, Aminian A. Effect of revisional bariatric surgery on type 2 diabetes mellitus. Surg Endosc. 2019 Aug;33(8):2642-2648. doi: 10.1007/s00464-018-6541-1. Epub 2018 Oct 19.
PubMed 30341657
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand-Sewn vs. Stapled Anastomosis in SADI-S: A Prospective Randomized Trial of Early Postoperative Complications.
- ClinicalTrials.gov ID
- NCT07348146
- Acronym / sponsor ID
- Stapled SADIs 082025
- Conditions
- Metabolic Surgery, Obesity & Overweight
- Keywords
- Stapled versus Hand-sewn Technique, SADI-s, Metabolic Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 16 Jan 2026 (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.
This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) | Active comparator | Procedure: Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) |
| Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) | Active comparator | Procedure: Stapled Single Anastomosis Duodena-ileal Sleeve |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-70
- Patients who will undergo SADI-S surgery
Key exclusion criteria (5 listed)
- Patients with severe medical conditions such as heart failure and interstitial lung disease.
- Patients with short bowel
- Patients with severe GERD
- Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements
- Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.
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 |
|---|---|---|
| Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)Arm 1 - Hand-sewn Duodeno-Ileal Anastomosis Following sleeve gastrectomy, a hand-sewn duodeno-ileal anastomosis is performed in two layers, with the inner layer constructed using absorbable barbed sutures and the outer reinforcing layer using absorbable monofilament sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol. | Procedure or surgery | Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) |
| Stapled Single Anastomosis Duodena-ileal SleeveArm 2 - Stapled Single Anastomosis Duodena-ileal Sleeve Following sleeve gastrectomy, a stapled duodeno-ileal anastomosis is created using endoscopic linear stapling devices, followed by closure of the enterotomy in a single layer using absorbable barbed sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol. | Procedure or surgery | Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) |
Primary outcome
Intestinal Injury
Time frame: One month after surgery
Anastomotic Leak Rate
Time frame: one month after the surgery
Post operative Bleeding
Time frame: One month after surgery
Anastomotic Stircture
Time frame: Six months after surgery
Operative Time
Time frame: Immediately after surgery
2 secondary outcomes
Weight loss
Time frame: Six months after surgery
Length of Hosptial Stay
Time frame: One month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 39525136Kshirsagar VV, Mp H. A Comparative Study of Hand-Sewn and Stapled Anastomosis in Gastrointestinal Surgeries. Cureus. 2024 Oct 11;16(10):e71264. doi: 10.7759/cureus.71264. eCollection 2024 Oct.
- Background: PubMed 40046528Ebinuma S, Kunisawa S, Fushimi K, Ichikawa N, Yoshida T, Homma S, Taketomi A, Imanaka Y. Comparative retrospective study on surgical outcomes of hand-sewn anastomosis versus stapling anastomosis for colectomy using a nationwide inpatient database in Japan with propensity score matching. Ann Gastroenterol Surg. 2024 Oct 11;9(2):379-388. doi: 10.1002/ags3.12870. eCollection 2025 Mar.
- Background: PubMed 35352174Pennestri F, Sessa L, Prioli F, Salvi G, Gallucci P, Ciccoritti L, Greco F, De Crea C, Raffaelli M. Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. Langenbecks Arch Surg. 2022 Aug;407(5):1851-1862. doi: 10.1007/s00423-022-02501-z. Epub 2022 Mar 29.
- Background: PubMed 30293134O'Brien PE, Hindle A, Brennan L, Skinner S, Burton P, Smith A, Crosthwaite G, Brown W. Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding. Obes Surg. 2019 Jan;29(1):3-14. doi: 10.1007/s11695-018-3525-0.
- Background: PubMed 32636173Lazzati A, Bechet S, Jouma S, Paolino L, Jung C. Revision surgery after sleeve gastrectomy: a nationwide study with 10 years of follow-up. Surg Obes Relat Dis. 2020 Oct;16(10):1497-1504. doi: 10.1016/j.soard.2020.05.021. Epub 2020 May 29.
- Background: PubMed 30341657Aleassa EM, Hassan M, Hayes K, Brethauer SA, Schauer PR, Aminian A. Effect of revisional bariatric surgery on type 2 diabetes mellitus. Surg Endosc. 2019 Aug;33(8):2642-2648. doi: 10.1007/s00464-018-6541-1. Epub 2018 Oct 19.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) and Stapled Single Anastomosis Duodena-ileal Sleeve in people with Metabolic Surgery and Obesity & Overweight, run by Kasr El Aini Hospital 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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intestinal Injury (time frame: One month after surgery). The study lists 5 primary outcomes in all. 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 NCT07348146, which also lists 6 linked publications.
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 22 Sep 2026.