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

NCT07238309 | Recruiting DMC

• 1 other identifier: laparoscopic gastric bypass
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To assess whether oversewing or the use of surgical clips is more effective in reducing operative time and Cost analysis in (OAGB).
3. 3.To Provide evidence-based recommendations on staple line reinforcement techniques in OAGB, emphasizing patient safety and procedural efficiency

Conditions

Gastric Bypass Surgery

Keywords

Laparoscopic One Anastomosis Gastric Bypass surgery

Outcome Measures

Primary Outcomes (1)

• 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: 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).

  30 days after laparoscopic one-anastomosis gastric bypass surgery

Secondary Outcomes (1)

• Operative Time

  Intraoperative (recorded during procedure)

Study Arms (2)

Through-and-through sutures

EXPERIMENTAL

through-and-through sutures with 3-0 absorbable monofilament sutures will be used .

Procedure: Oversewing

Titanium Ligation clips

EXPERIMENTAL

Titanium Ligation clips will be used .

Procedure: Surgical Ligation Clips

Interventions

Oversewing PROCEDURE

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.

Through-and-through sutures

Surgical Ligation Clips PROCEDURE

Titanium Ligation clips will be used to secure hemostasis and reinforce staple line by approximating tissue edges in laparoscopic one anastomosis gastric bypass surgery.

Titanium Ligation clips

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ✔ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 28604169 BACKGROUND

• Wolfe 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.

  PMID: 27230645 BACKGROUND

Study Officials

• George AbdElFady Nashed Aiad, M.D

  professor in General and Laparoscopic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameh Gamal Abd Elghany, MSc

CONTACT

01001841011; smsm_surgeon@yahoo.com

George AbdElFady Nashed Aiad, M.D

CONTACT

01223980146; george.ayad@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General and Laparoscopic surgeon

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 20, 2025
• Study Start: May 18, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

EG (1)