Gastric Bypass SurgeryNCT07238309
Efficacy of Oversewing Versus Surgical Ligation Clips for Staple Line Reinforcement of the Gastric Pouch to Reduce Post Operative Bleeding in Laparoscopic One Anastomosis Gastric Bypass
A study testing Oversewing and Surgical Ligation Clips in people with Gastric Bypass Surgery, run by Cairo University at 1 site in Egypt.
Trial summary
1. To test if there is a significant differences between Oversewing versus surgical ligation clips for staple line reinforcement of the gastric pouch regarding the reduction of post operative bleeding and the need for blood transfusions in laparoscopic one anastomosis gastric bypass. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Bypass Surgery
- What is being tested?
- Oversewing and Surgical Ligation Clips
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 May 2025to Jun 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ✔ Age ≥ 18years old
- Sex: both sex
- Fit for bariatric surgery
- body mass index (BMI) of 40 kg/m 2 or higher or BMI between 35 and 40 kg/m2 with significant comorbidities, such as T2DM, hypertension, OSAS or significant osteo- articular alterations, not responsive to medical therapies
- Patients should have tried and failed to lose weight using diet, exercise, and/or medication for at least 6 months
- Patients or first guardians accept to participate in the current study
- Patients or first guardians accept to provide informed written consent
Who cannot join
- Patients less than 18 years old
- Patients or first guardians refused to participate in the current study
- Patients or first guardians refused to provide informed written consent
- All patients with bleeding disorders and patients needing re-exploration for bleeding other than staple line Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate
About this study
Official title: A Comparative Study to Evaluate Efficacy of Oversewing Versus Surgical Ligation Clips for Staple Line Reinforcement of the Gastric Pouch to Reduce Post Operative Bleeding in Laparoscopic One Anastomosis Gastric Bypass
- To test if there is a significant differences between Oversewing versus surgical ligation clips for staple line reinforcement of the gastric pouch regarding the reduction of post operative bleeding and the need for blood transfusions in laparoscopic one anastomosis gastric bypass.
- To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB).
- To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency
Read the detailed description
Obesity is a disease related to reduced life expectancy, as well as increased morbidity and mortality. In recent years, bariatric surgery has become an increasingly widespread form of treatment for severe obesity and its associated diseases . The increased spread of bariatric surgery is associated with its long-term reliability and also its high cost-benefit ratio.
According to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) registry (calendar years 2014-2018), there are three main surgical procedures in common use: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) and laparoscopic one anastomosis gastric bypass (OAGB) . OAGB, introduced by Rutledge in 1997 is a restrictive and malabsorptive bariatric surgical procedure and is the fourth most performed bariatric technique in Europe and in the Asia/Pacific area, with an increasing trend .
In the last 15 years, several authors have demonstrated the effectiveness of this surgical technique in terms of both weight loss and the resolution of comorbidities, especially type 2 diabetes mellitus (T2DM).
Despite the described advantages, LSG still conveys some risks. Early staple line complications, such as bleeding and leaks, may occur, and their incidence may vary from 1 to 6% . Such complications can be devastating and life-threatening. Besides, they entail additional healthcare-related costs. It has been proposed that staple line complications can be reduced by staple line reinforcement (SLR).
Staple line reinforcement (SLR) has been proposed to decrease the risk of these complications by several options: oversewing the staple line with a running absorbable suture, buttressing it with specific materials or roofing the staple line. Although it has been postulated that there are fewer complications, SLR remains controversial and its effectiveness is still unclear . Some surgeons still have concerns about SLR, either because of Uncertainty about its benefits and/or its financial costs. Moreover, it has been argued that oversewing itself could carry additional risks. The potential for leakage and bleeding could increase due to tearing at the suture penetration point, and the running suture may lead to sleeve stricture and tissue ischemia.
Two common techniques for this purpose are oversewing and the use of surgical ligation clips. Oversewing involves suturing over the staple line, which has been shown to significantly reduce the incidence of staple line bleeding, with rates dropping from 9-13.7% to as low as 1.4-2%, While effective and cost-efficient.
Oversewing can increase operative time due to the additional suturing required .
On the other hand, surgical ligation clips provide a rapid method for achieving hemostasis and reinforcing the staple line. Research indicates that ligation clips are effective in controlling bleeding, with low complication rates (e.g., only 1.7% episodes of melena reported).
Both techniques demonstrate comparable efficacy in preventing complications, and the choice between them may depend on clinical context, surgeon preference, and resource availability. Further studies comparing long-term outcomes would enhance understanding of their relative effectiveness.
- Conditions
- Gastric Bypass Surgery
- Being tested
- Oversewing, Surgical Ligation Clips
- Keywords
- Laparoscopic One Anastomosis Gastric Bypass surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OversewingProcedure or surgery
Through-and-through sutures with 3-0 absorbable monofilament sutures will be placed over the staple line to reinforce it in laparoscopic one anastomosis gastric bypass surgery.
Surgical Ligation ClipsProcedure or surgery
Titanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery.
| Study group | Role | What they receive |
|---|---|---|
| Through-and-through sutures | Experimental | through-and-through sutures with 3-0 absorbable monofilament sutures will be used . Receives: Procedure: Oversewing |
| Titanium Ligation clips | Experimental | Titanium Ligation clips will be used . Receives: Procedure: Surgical Ligation Clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant Postoperative Bleeding Within 30 Days
Proportion of participants experiencing clinically significant postoperative bleeding within 30 days of laparoscopic one-anastomosis gastric bypass.
Clinically significant postoperative bleeding is defined as the occurrence of any of the following events within 30 days after surgery:
- Re-operation for bleeding,
- Endoscopic or radiologic intervention to control bleeding,
- Transfusion of ≥ 1 unit of packed red blood cells for acute postoperative blood loss, or
- Hemoglobin drop ≥ 2.0 g/dL from immediate postoperative baseline accompanied by hemodynamic instability (systolic blood pressure < 90 mmHg or requiring vasopressor support).
The analysis metric will be the number and percentage of participants (n, %) with at least one bleeding event in each treatment arm. Between-group comparison will use the risk difference with 95 % confidence interval (or the pre-specified statistical test per the statistical analysis plan).
Measured: 30 days after laparoscopic one-anastomosis gastric bypass surgery
Secondary outcomes (1)
Operative Time
Duration of surgery measured in minutes from skin incision to skin closure. Analysis metric: mean (SD) operative time per group; compared using pre-specified statistical tests.
Measured: Intraoperative (recorded during procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start18 May 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Gamal Abd Elghany, Cairo University
- Investigators
- George AbdElFady Nashed Aiad, M.D, Principal investigator, professor in General and Laparoscopic surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238309
- Sponsor's protocol ID
- laparoscopic gastric bypass
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
PubMed 28604169Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.
PubMed 27230645
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Evaluate Efficacy of Oversewing Versus Surgical Ligation Clips for Staple Line Reinforcement of the Gastric Pouch to Reduce Post Operative Bleeding in Laparoscopic One Anastomosis Gastric Bypass
- ClinicalTrials.gov ID
- NCT07238309
- Acronym / sponsor ID
- laparoscopic gastric bypass
- Conditions
- Gastric Bypass Surgery
- Keywords
- Laparoscopic One Anastomosis Gastric Bypass surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Nov 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.
- To test if there is a significant differences between Oversewing versus surgical ligation clips for staple line reinforcement of the gastric pouch regarding the reduction of post operative bleeding and the need for blood transfusions in laparoscopic one anastomosis gastric bypass.
- To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB).
- To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency
Detailed description
Obesity is a disease related to reduced life expectancy, as well as increased morbidity and mortality. In recent years, bariatric surgery has become an increasingly widespread form of treatment for severe obesity and its associated diseases . The increased spread of bariatric surgery is associated with its long-term reliability and also its high cost-benefit ratio.
According to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) registry (calendar years 2014-2018), there are three main surgical procedures in common use: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) and laparoscopic one anastomosis gastric bypass (OAGB) . OAGB, introduced by Rutledge in 1997 is a restrictive and malabsorptive bariatric surgical procedure and is the fourth most performed bariatric technique in Europe and in the Asia/Pacific area, with an increasing trend .
In the last 15 years, several authors have demonstrated the effectiveness of this surgical technique in terms of both weight loss and the resolution of comorbidities, especially type 2 diabetes mellitus (T2DM).
Despite the described advantages, LSG still conveys some risks. Early staple line complications, such as bleeding and leaks, may occur, and their incidence may vary from 1 to 6% . Such complications can be devastating and life-threatening. Besides, they entail additional healthcare-related costs. It has been proposed that staple line complications can be reduced by staple line reinforcement (SLR).
Staple line reinforcement (SLR) has been proposed to decrease the risk of these complications by several options: oversewing the staple line with a running absorbable suture, buttressing it with specific materials or roofing the staple line. Although it has been postulated that there are fewer complications, SLR remains controversial and its effectiveness is still unclear . Some surgeons still have concerns about SLR, either because of Uncertainty about its benefits and/or its financial costs. Moreover, it has been argued that oversewing itself could carry additional risks. The potential for leakage and bleeding could increase due to tearing at the suture penetration point, and the running suture may lead to sleeve stricture and tissue ischemia.
Two common techniques for this purpose are oversewing and the use of surgical ligation clips. Oversewing involves suturing over the staple line, which has been shown to significantly reduce the incidence of staple line bleeding, with rates dropping from 9-13.7% to as low as 1.4-2%, While effective and cost-efficient.
Oversewing can increase operative time due to the additional suturing required .
On the other hand, surgical ligation clips provide a rapid method for achieving hemostasis and reinforcing the staple line. Research indicates that ligation clips are effective in controlling bleeding, with low complication rates (e.g., only 1.7% episodes of melena reported).
Both techniques demonstrate comparable efficacy in preventing complications, and the choice between them may depend on clinical context, surgeon preference, and resource availability. Further studies comparing long-term outcomes would enhance understanding of their relative effectiveness.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Through-and-through sutures | Experimental | Procedure: Oversewingthrough-and-through sutures with 3-0 absorbable monofilament sutures will be used . |
| Titanium Ligation clips | Experimental | Procedure: Surgical Ligation ClipsTitanium Ligation clips will be used . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ✔ Age ≥ 18years old
Key exclusion criteria (4 listed)
- Patients less than 18 years old
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 |
|---|---|---|
| OversewingThrough-and-through sutures with 3-0 absorbable monofilament sutures will be placed over the staple line to reinforce it in laparoscopic one anastomosis gastric bypass surgery. | Procedure or surgery | Through-and-through sutures |
| Surgical Ligation ClipsTitanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery. | Procedure or surgery | Titanium Ligation clips |
Primary outcome
Incidence of Clinically Significant Postoperative Bleeding Within 30 Days
Time frame: 30 days after laparoscopic one-anastomosis gastric bypass surgery
Proportion of participants experiencing clinically significant postoperative bleeding within 30 days of laparoscopic one-anastomosis gastric bypass. Clinically significant postoperative bleeding is defined as the occurrence of any of the following events within 30 days after surgery: 1. Re-operation for bleeding, 2. Endoscopic or radiologic intervention to control bleeding, 3. Transfusion of ≥ 1 unit of packed red blood cells for acute postoperative blood loss, or 4. Hemoglobin drop ≥ 2.0 g/dL from immediate postoperative baseline accompanied by hemodynamic instability (systolic blood pressure < 90 mmHg or requiring vasopressor support). The analysis metric will be the number and percentage of participants (n, %) with at least one bleeding event in each treatment arm. Between-group comparison will use the risk difference with 95 % confidence interval (or the pre-specified statistical test per the statistical analysis plan).
1 secondary outcome
Operative Time
Time frame: Intraoperative (recorded during procedure)
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 20 Nov 2025.
- Background: PubMed 28604169GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
- Background: PubMed 27230645Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.
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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.
George AbdElFady Nashed Aiad, M.D principal investigator
professor in General and Laparoscopic surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oversewing and Surgical Ligation Clips in people with Gastric Bypass Surgery, run by Cairo 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 7 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: looking for participants now, as of the sponsor's last update on 20 Nov 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?
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?
Contact Sameh Gamal Abd Elghany, MSc (01001841011, smsm_surgeon@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant Postoperative Bleeding Within 30 Days (time frame: 30 days after laparoscopic one-anastomosis gastric bypass surgery). 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 NCT07238309, which also lists 2 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 20 Nov 2025.