Postoperative HemorrhageWARM-LSGNCT07475169
Warm Saline Irrigation Before Omentopexy to Reduce Early Bleeding After Laparoscopic Sleeve Gastrectomy
A study testing Warm Saline Irrigation and Room Temperature Saline Irrigation in people with Postoperative Hemorrhage and Obesity, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective randomized clinical trial evaluates whether warming saline irrigation (37-40 °C) applied to the gastric staple line before performing omentopexy during laparoscopic sleeve gastrectomy (LSG) can reduce early postoperative bleeding compared with conventional room-temperature saline irrigation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Hemorrhage, Obesity
- What is being tested?
- Warm Saline Irrigation and Room Temperature Saline Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- BMI ≥ 40 kg/m², or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea)
- Eligible for primary laparoscopic sleeve gastrectomy
- Provided written informed consent
Who cannot join
- Previous major upper abdominal surgery with expected adhesions
- Known bleeding disorders
- Use of anticoagulant or antiplatelet therapy within 7 days before surgery
- Advanced hepatic or renal disease
- Unstable cardiac conditions
- Pregnancy
Show all 9Show fewer
- Immunosuppression
- Active systemic infection
- Inability to comply with follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Warm Staple-Line Irrigation (37-40 °C) Before Omentopexy Reduces Early Bleeding After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial
This prospective randomized clinical trial evaluates whether warming saline irrigation (37-40 °C) applied to the gastric staple line before performing omentopexy during laparoscopic sleeve gastrectomy (LSG) can reduce early postoperative bleeding compared with conventional room-temperature saline irrigation.
Staple-line bleeding remains one of the most relevant early complications after LSG and may lead to hemoglobin drop, prolonged drainage, blood transfusion, or re-intervention. Although reinforcement techniques such as oversewing or buttressing materials are commonly used, they may increase operative time and cost. Irrigation of the operative field is routinely performed during LSG to improve visualization; however, the potential effect of irrigation temperature on hemostasis has not been previously evaluated in bariatric surgery.
Read more
In this trial, 200 adult patients undergoing primary LSG were randomized in a 1:1 ratio to receive either warm saline irrigation (37-40 °C) or standard room-temperature saline irrigation (22-24 °C) applied directly to the staple line before omentopexy. All other operative steps were standardized.
The primary outcome is early postoperative bleeding within 48 hours. Secondary outcomes include hemoglobin drop, drain output, need for additional hemostatic maneuvers, operative efficiency, postoperative pain, length of hospital stay, and 30-day complications.
This study investigates a simple, low-cost, and easily applicable intraoperative modification that may enhance staple-line hemostasis and improve early recovery following LSG.
Read the detailed description
Study Design and Rationale:
This study is a prospective, randomized, controlled clinical trial conducted at two high-volume tertiary bariatric centers. The aim is to evaluate whether irrigation of the gastric staple line with physiologically warm saline (37-40 °C) before performing omentopexy improves intraoperative hemostasis and reduces early postoperative bleeding following laparoscopic sleeve gastrectomy (LSG).
Irrigation of the operative field is standard practice during laparoscopic surgery to clear blood and enhance visualization. However, the effect of irrigation temperature on staple-line hemostasis in bariatric surgery has not been previously studied. Warm irrigation has demonstrated hemostatic and recovery benefits in other surgical specialties. This trial compares two clinically relevant strategies: warm saline versus conventional room-temperature saline.
Participants:
A total of 200 adult patients (18-60 years) undergoing primary LSG were enrolled. Inclusion criteria included BMI ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities. Patients with coagulopathy, recent anticoagulant use, prior major upper abdominal surgery, advanced organ failure, pregnancy, or inability to complete follow-up were excluded.
Randomization and Allocation:
Patients were randomized in a 1:1 ratio using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Surgeons were aware of the irrigation temperature, while postoperative assessors and patients were blinded to group allocation.
Intervention:
After completion of gastric transection using a 36-French bougie calibration, patients received:
- Warm Irrigation Group: 400 mL sterile saline at 37-40 °C applied along the staple line.
- Control Group: 400 mL sterile saline at 22-24 °C applied identically.
After irrigation and complete suctioning, the staple line was inspected and any active bleeding was controlled using bipolar cautery or clips. Standardized omentopexy was then performed in all patients using interrupted 2-0 PDS sutures spaced 2 cm apart.
No buttressing material, sealants, or additional reinforcement techniques were used in either group.
Primary Outcome:
Early postoperative bleeding within 48 hours, defined as any of the following:
- Hemoglobin drop ≥ 2 g/dL
- Drain output ≥ 150 mL sanguineous fluid within 24 hours
- Clinical signs of bleeding
- Need for endoscopic or surgical hemostasis
Secondary Outcomes:
- Hemostasis-phase duration
- Hemoglobin drop (continuous variable)
- 24-hour drain output
- Additional intraoperative hemostatic maneuvers
- Postoperative pain scores
- Postoperative nausea and vomiting
- Length of hospital stay
- 30-day complications (Clavien-Dindo classification)
- Reoperation or readmission
Follow-up:
Patients were evaluated during hospitalization and followed at 1 week, 1 month, and 3 months postoperatively. All randomized patients completed follow-up and were included in intention-to-treat analysis.
Statistical Considerations:
Sample size was calculated to detect reduction in bleeding incidence from 15% to 5% with 80% power. Statistical significance was defined as p < 0.05.
This study evaluates a safe, inexpensive, and easily reproducible intraoperative modification that may improve staple-line hemostasis and early recovery after LSG.
- Conditions
- Postoperative Hemorrhage, Obesity
- Being tested
- Warm Saline Irrigation, Room Temperature Saline Irrigation
- Keywords
- laparoscopic sleeve gastrectomy, warm saline irrigation, staple line, omentopexy, postoperative bleeding, bariatric surgery, randomized clinical trial, hemostasis
- Medical subject headings
- Postoperative Hemorrhage, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Saline IrrigationProcedure or surgery
Irrigation of the gastric staple line using warm saline (37-40°C) prior to omentopexy.
Room Temperature Saline IrrigationProcedure or surgery
Irrigation of the gastric staple line using room-temperature saline prior to omentopexy.
| Study group | Role | What they receive |
|---|---|---|
| Warm Saline Irrigation | Experimental | Warm saline irrigation (37-40°C) applied to the gastric staple line before omentopexy during laparoscopic sleeve gastrectomy. Receives: Procedure: Warm Saline Irrigation |
| Room Temperature Saline | Active comparator | Standard room-temperature saline irrigation applied to the gastric staple line before omentopexy. Receives: Procedure: Room Temperature Saline Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early postoperative bleeding (composite outcome)
Composite endpoint defined as the occurrence of any of the following within 48 hours after surgery:
- Clinical evidence of bleeding
- Hemoglobin drop ≥2 g/dL on postoperative day 1
- Drain output >150 mL within 24 hours
- Need for endoscopic or surgical hemostasis
Measured: Within 48 hours after surgery
Secondary outcomes (8)
Hemostasis-phase duration (minutes)
Time required to achieve complete staple-line hemostasis after sleeve transection and prior to omentopexy (measured intraoperatively, in minutes).
Measured: During surgery (intraoperative)
Additional intraoperative hemostatic maneuvers
Proportion of participants requiring additional hemostatic maneuvers (e.g., bipolar coagulation and/or clipping) to control staple-line bleeding.
Measured: During surgery (intraoperative)
Hemoglobin drop (ΔHb) from baseline to postoperative day 1 (g/dL)
Change in hemoglobin level (g/dL) calculated as preoperative hemoglobin minus postoperative day 1 hemoglobin (continuous outcome).
Measured: From preoperative baseline to postoperative day 1
Drain output volume in the first 24 hours (mL)
Total drain output volume (mL) during the first 24 hours after surgery; measured every 8 hours and summed (continuous outcome).
Measured: Postoperative 0-24 hours
Postoperative pain intensity at 24 hours
Pain intensity assessed at 24 hours after surgery using the Visual Analog Scale (0-10). Higher scores indicate worse pain.
Measured: 24 hours after surgery
Postoperative nausea and vomiting (PONV) within 48 hours
Occurrence of postoperative nausea and/or vomiting and/or need for antiemetics in the early postoperative period.
Measured: Postoperative day 0 to day 2 (within 48 hours)
Length of hospital stay (days)
Total duration of index hospitalization measured in days from the date of surgery to the date of hospital discharge. Reported as a continuous outcome (mean number of days).
Measured: Perioperative
30-day postoperative complications (Clavien-Dindo)
Binary outcome (Yes/No) indicating the occurrence of any postoperative complication within 30 days after surgery, classified according to the Clavien-Dindo system. The outcome is reported as the proportion of participants experiencing at least one complication.
Measured: Within 30 days 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 Mar 2026
- Study start1 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 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 Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel-group clinical trial. Participants undergoing laparoscopic sleeve gastrectomy are randomly assigned in a 1:1 ratio to receive either warm saline irrigation (37-40°C) of the staple line before omentopexy or standard room-temperature saline irrigation. Outcomes are compared between the two independent groups.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475169
- Sponsor's protocol ID
- FMASU-REC-49/2024
- Acronym
- WARM-LSG
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdalla GM, Farrag AM, Halim GM. Warm staple-line irrigation (37-40 degrees C) before omentopexy reduces early bleeding after laparoscopic sleeve gastrectomy: a prospective, randomized trial. BMC Surg. 2026 Jun 16;26(1):417. doi: 10.1186/s12893-026-03924-x.
PubMed 42304298
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warm Staple-Line Irrigation (37-40 °C) Before Omentopexy Reduces Early Bleeding After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07475169
- Acronym / sponsor ID
- WARM-LSG / FMASU-REC-49/2024
- Conditions
- Postoperative Hemorrhage, Obesity
- Keywords
- laparoscopic sleeve gastrectomy, warm saline irrigation, staple line, omentopexy, postoperative bleeding, bariatric surgery, randomized clinical trial, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Mar 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 prospective randomized clinical trial evaluates whether warming saline irrigation (37-40 °C) applied to the gastric staple line before performing omentopexy during laparoscopic sleeve gastrectomy (LSG) can reduce early postoperative bleeding compared with conventional room-temperature saline irrigation.
Staple-line bleeding remains one of the most relevant early complications after LSG and may lead to hemoglobin drop, prolonged drainage, blood transfusion, or re-intervention. Although reinforcement techniques such as oversewing or buttressing materials are commonly used, they may increase operative time and cost. Irrigation of the operative field is routinely performed during LSG to improve visualization; however, the potential effect of irrigation temperature on hemostasis has not been previously evaluated in bariatric surgery.
In this trial, 200 adult patients undergoing primary LSG were randomized in a 1:1 ratio to receive either warm saline irrigation (37-40 °C) or standard room-temperature saline irrigation (22-24 °C) applied directly to the staple line before omentopexy. All other operative steps were standardized.
The primary outcome is early postoperative bleeding within 48 hours. Secondary outcomes include hemoglobin drop, drain output, need for additional hemostatic maneuvers, operative efficiency, postoperative pain, length of hospital stay, and 30-day complications.
This study investigates a simple, low-cost, and easily applicable intraoperative modification that may enhance staple-line hemostasis and improve early recovery following LSG.
Detailed description
Study Design and Rationale:
This study is a prospective, randomized, controlled clinical trial conducted at two high-volume tertiary bariatric centers. The aim is to evaluate whether irrigation of the gastric staple line with physiologically warm saline (37-40 °C) before performing omentopexy improves intraoperative hemostasis and reduces early postoperative bleeding following laparoscopic sleeve gastrectomy (LSG).
Irrigation of the operative field is standard practice during laparoscopic surgery to clear blood and enhance visualization. However, the effect of irrigation temperature on staple-line hemostasis in bariatric surgery has not been previously studied. Warm irrigation has demonstrated hemostatic and recovery benefits in other surgical specialties. This trial compares two clinically relevant strategies: warm saline versus conventional room-temperature saline.
Participants:
A total of 200 adult patients (18-60 years) undergoing primary LSG were enrolled. Inclusion criteria included BMI ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities. Patients with coagulopathy, recent anticoagulant use, prior major upper abdominal surgery, advanced organ failure, pregnancy, or inability to complete follow-up were excluded.
Randomization and Allocation:
Patients were randomized in a 1:1 ratio using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Surgeons were aware of the irrigation temperature, while postoperative assessors and patients were blinded to group allocation.
Intervention:
After completion of gastric transection using a 36-French bougie calibration, patients received:
- Warm Irrigation Group: 400 mL sterile saline at 37-40 °C applied along the staple line.
- Control Group: 400 mL sterile saline at 22-24 °C applied identically.
After irrigation and complete suctioning, the staple line was inspected and any active bleeding was controlled using bipolar cautery or clips. Standardized omentopexy was then performed in all patients using interrupted 2-0 PDS sutures spaced 2 cm apart.
No buttressing material, sealants, or additional reinforcement techniques were used in either group.
Primary Outcome:
Early postoperative bleeding within 48 hours, defined as any of the following:
- Hemoglobin drop ≥ 2 g/dL
- Drain output ≥ 150 mL sanguineous fluid within 24 hours
- Clinical signs of bleeding
- Need for endoscopic or surgical hemostasis
Secondary Outcomes:
- Hemostasis-phase duration
- Hemoglobin drop (continuous variable)
- 24-hour drain output
- Additional intraoperative hemostatic maneuvers
- Postoperative pain scores
- Postoperative nausea and vomiting
- Length of hospital stay
- 30-day complications (Clavien-Dindo classification)
- Reoperation or readmission
Follow-up:
Patients were evaluated during hospitalization and followed at 1 week, 1 month, and 3 months postoperatively. All randomized patients completed follow-up and were included in intention-to-treat analysis.
Statistical Considerations:
Sample size was calculated to detect reduction in bleeding incidence from 15% to 5% with 80% power. Statistical significance was defined as p < 0.05.
This study evaluates a safe, inexpensive, and easily reproducible intraoperative modification that may improve staple-line hemostasis and early recovery after LSG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-group clinical trial. Participants undergoing laparoscopic sleeve gastrectomy are randomly assigned in a 1:1 ratio to receive either warm saline irrigation (37-40°C) of the staple line before omentopexy or standard room-temperature saline irrigation. Outcomes are compared between the two independent groups.
| Arm | Type | Receives |
|---|---|---|
| Warm Saline Irrigation | Experimental | Procedure: Warm Saline IrrigationWarm saline irrigation (37-40°C) applied to the gastric staple line before omentopexy during laparoscopic sleeve gastrectomy. |
| Room Temperature Saline | Active comparator | Procedure: Room Temperature Saline IrrigationStandard room-temperature saline irrigation applied to the gastric staple line before omentopexy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years
- BMI ≥ 40 kg/m², or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea)
- Eligible for primary laparoscopic sleeve gastrectomy
- Provided written informed consent
Key exclusion criteria (9 listed)
- Previous major upper abdominal surgery with expected adhesions
- Known bleeding disorders
- Use of anticoagulant or antiplatelet therapy within 7 days before surgery
- Advanced hepatic or renal disease
- Unstable cardiac conditions
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 |
|---|---|---|
| Warm Saline IrrigationIrrigation of the gastric staple line using warm saline (37-40°C) prior to omentopexy. | Procedure or surgery | Warm Saline Irrigation |
| Room Temperature Saline IrrigationIrrigation of the gastric staple line using room-temperature saline prior to omentopexy. | Procedure or surgery | Room Temperature Saline |
Primary outcome
Incidence of early postoperative bleeding (composite outcome)
Time frame: Within 48 hours after surgery
Composite endpoint defined as the occurrence of any of the following within 48 hours after surgery: 1. Clinical evidence of bleeding 2. Hemoglobin drop ≥2 g/dL on postoperative day 1 3. Drain output >150 mL within 24 hours 4. Need for endoscopic or surgical hemostasis
8 secondary outcomes
Hemostasis-phase duration (minutes)
Time frame: During surgery (intraoperative)
Additional intraoperative hemostatic maneuvers
Time frame: During surgery (intraoperative)
Hemoglobin drop (ΔHb) from baseline to postoperative day 1 (g/dL)
Time frame: From preoperative baseline to postoperative day 1
Drain output volume in the first 24 hours (mL)
Time frame: Postoperative 0-24 hours
Postoperative pain intensity at 24 hours
Time frame: 24 hours after surgery
Postoperative nausea and vomiting (PONV) within 48 hours
Time frame: Postoperative day 0 to day 2 (within 48 hours)
Length of hospital stay (days)
Time frame: Perioperative
30-day postoperative complications (Clavien-Dindo)
Time frame: Within 30 days after surgery
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 16 Mar 2026.
- Derived from this study: PubMed 42304298Abdalla GM, Farrag AM, Halim GM. Warm staple-line irrigation (37-40 degrees C) before omentopexy reduces early bleeding after laparoscopic sleeve gastrectomy: a prospective, randomized trial. BMC Surg. 2026 Jun 16;26(1):417. doi: 10.1186/s12893-026-03924-x.
- Individual participant dataSharing planned: No
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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?
A study testing Warm Saline Irrigation and Room Temperature Saline Irrigation in people with Postoperative Hemorrhage and Obesity, run by Ain Shams 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 4 inclusion and 9 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 16 Mar 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?
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 early postoperative bleeding (composite outcome) (time frame: Within 48 hours after 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 NCT07475169, 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 16 Mar 2026.