Severe ObesityNCT07919067
Closure Versus Non-Closure of Working Ports in Laparoscopic Sleeve Gastrectomy
A study testing Non-closure of working port fascia (skin closure only) and Fascial closure of working ports in people with Severe Obesity and Port-Site Hernia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This randomized controlled trial compared closure versus non-closure of the fascia at the working port (trocar) sites during laparoscopic sleeve gastrectomy for severe obesity. A total of 160 adult patients undergoing laparoscopic sleeve gastrectomy at Kasr Al Ainy Hospital, Cairo University, were randomly allocated… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Obesity, Port-Site Hernia, Postoperative Pain
- What is being tested?
- Non-closure of working port fascia (skin closure only) and Fascial closure of working ports
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 31 May 2026
- 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
- Patients scheduled for laparoscopic sleeve gastrectomy
- Age between 18 and 60 years at the time of surgery
- Body mass index (BMI) greater than 35 kg/m2, or greater than 30 kg/m2 with significant obesity-related comorbidity
- Failure of adequate conservative management, including dietary modification, exercise and/or medical therapy, for at least six months
- Psychological stability and acceptance of surgical risks
Who cannot join
- Pre-existing nutritional deficiency
- Pregnancy or lactation
- Significant long-standing cardiac or pulmonary disease
- Severe systemic illness
- Active substance or alcohol abuse
- Active gastric ulcer disease
- Gastroesophageal reflux disease (GERD)
- Psychologically unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Closure Versus Non-Closure of Working Ports in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial
This randomized controlled trial compared closure versus non-closure of the fascia at the working port (trocar) sites during laparoscopic sleeve gastrectomy for severe obesity.
A total of 160 adult patients undergoing laparoscopic sleeve gastrectomy at Kasr Al Ainy Hospital, Cairo University, were randomly allocated (1:1) to non-closure of the working ports (skin closure only) or fascial closure of the working ports using a fascial closure device.
Patients were followed for one year for the development of port-site hernia. Postoperative pain was assessed with the Visual Analogue Scale (VAS) at one week and one month, and functional recovery with the Quality of Recovery-15 (QoR-15) score at one week.
Read the detailed description
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed metabolic bariatric procedures. Port-site complications remain clinically important after laparoscopic surgery, particularly port-site hernia and postoperative pain. Fascial closure of trocar sites measuring 10 mm or larger is traditionally recommended to reduce the risk of port-site hernia; however, fascial closure may increase postoperative pain and delay functional recovery.
Aim: To compare closure versus non-closure of the working ports during laparoscopic sleeve gastrectomy with respect to port-site hernia occurrence, postoperative pain severity, and functional recovery measured by the QoR-15 score.
Design and setting: Single-centre, parallel-group randomized controlled trial conducted at Kasr Al Ainy Hospital, General Surgery Department, Faculty of Medicine, Cairo University.
Study period: Patients were enrolled from October 2024 to June 2025 and followed for one year after surgery; data collection was completed at the end of May 2026.
Randomization: An online randomization program (randomizer.org) was used to generate a random list, and each patient's allocation code was kept in an opaque sealed envelope. Patients were allocated in a 1:1 ratio to two parallel groups:
- Group A (n = 80): non-closure of the working ports (skin closure only).
- Group B (n = 80): closure of the working ports using a fascial closure device (Karl Storz SE \& Co. KG, Tuttlingen, Germany).
Preoperative assessment: Full history and clinical examination, anthropometric measurements (weight, BMI), routine laboratory investigations (complete blood count, liver and kidney function tests, coagulation profile, blood glucose, lipid profile), chest radiography, electrocardiography, anaesthetic assessment, and nutritional and psychological evaluation.
Operative technique: All operations were performed under balanced general anaesthesia with a transversus abdominis plane (TAP) block, in the supine position, with reverse Trendelenburg positioning after trocar insertion. Pneumoperitoneum was established with a Veress needle and trocars were inserted under direct vision. Dissection began approximately 4-6 cm proximal to the pylorus; the gastrocolic ligament and greater-curvature vessels were divided with an energy device and the fundus was fully mobilized up to the angle of His. A 36 Fr calibration bougie was placed along the lesser curvature and sequential stapler firings created the sleeve. Haemostasis and sleeve configuration were checked, and a methylene blue leak test was performed.
Port closure: In Group A only skin closure of the working port sites was performed. In Group B the fascial edges of the working ports were approximated under direct laparoscopic vision with the fascial closure device before skin closure.
Postoperative care: Standard care for all patients, including intravenous fluids, analgesia, early ambulation, venous thromboembolism prophylaxis and gradual oral intake according to the bariatric protocol.
Follow-up: Port-site pain at 1 week and 1 month; functional recovery (QoR-15) at 1 week; clinical examination for port-site hernia at each visit and abdominal wall ultrasound at 1 year.
Statistical analysis: Quantitative variables are expressed as mean and standard deviation and compared with Student's t-test; qualitative variables are expressed as number and percentage and compared with the chi-square or Fisher exact test. P < 0.05 is considered statistically significant.
- Conditions
- Severe Obesity, Port-Site Hernia, Postoperative Pain
- Being tested
- Non-closure of working port fascia (skin closure only), Fascial closure of working ports
- Keywords
- Sleeve Gastrectomy, Metabolic Bariatric Surgery, Trocar-Site Hernia, Port Closure, Fascial Closure, Postoperative Pain, Quality of Recovery-15, Functional Recovery
- Medical subject headings
- Obesity, Morbid, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-closure of working port fascia (skin closure only)Procedure or surgery
At the end of laparoscopic sleeve gastrectomy, the fascial defects of the working ports are left unclosed and only the skin is closed using standard suturing techniques.
Fascial closure of working portsProcedure or surgery
Also called Trocar-site fascial closure
At the end of laparoscopic sleeve gastrectomy, the fascial edges of the working port sites are approximated under direct laparoscopic vision using a fascial closure device (Karl Storz SE \& Co. KG, Tuttlingen, Germany), followed by skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Non-closure of working ports | Experimental | Laparoscopic sleeve gastrectomy with non-closure of the fascia at the working port sites; only skin closure is performed using standard suturing techniques. Receives: Procedure: Non-closure of working port fascia (skin closure only) |
| Group B: Closure of working ports | Active comparator | Laparoscopic sleeve gastrectomy with fascial closure of the working port sites using a fascial closure device (Karl Storz SE \& Co. KG, Tuttlingen, Germany) under direct laparoscopic vision, followed by skin closure. Receives: Procedure: Fascial closure of working ports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of port-site hernia
Number and percentage of patients who developed a port-site (trocar-site) hernia at the working port sites. Diagnosis was based on clinical examination at each follow-up visit (presence of swelling at the trocar site) with radiological confirmation by abdominal wall ultrasound at 1 year.
Measured: 12 months after surgery
Secondary outcomes (2)
Postoperative port-site pain (Visual Analogue Scale)
Port-site pain assessed with the Visual Analogue Scale (VAS), range 0 (no pain) to 10 (worst possible pain); higher scores indicate worse pain. Mild pain = 1-3, moderate pain = 4-7, severe pain = 8-10. Clinically significant pain is defined as VAS 4 or more; the number of patients with clinically significant pain is reported in each group.
Measured: 1 week and 1 month after surgery
Functional recovery (Quality of Recovery-15 score)
Quality of postoperative recovery assessed with the 15-item Quality of Recovery (QoR-15) questionnaire, covering physical well-being, pain and emotional state. Total score ranges from 0 to 150; higher scores indicate better recovery. Scores are categorized as excellent (136-150), good (122-135) or moderate (90-121); the percentage of patients with excellent recovery is reported in each group.
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Oct 2024
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients scheduled for laparoscopic sleeve gastrectomy were randomly allocated (1:1) to two parallel groups: non-closure of the working ports (skin closure only) versus fascial closure of the working ports with a fascial closure device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam M, Cairo University
- Investigators
- Ahmed Mohamed Abdelsalam, Principal investigator, Cairo UniversityMohamed Hassan Ali Fahmy, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919067
- Sponsor's protocol ID
- MS-109-2025
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data publicly available. De-identified data may be shared by the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Closure Versus Non-Closure of Working Ports in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07919067
- Acronym / sponsor ID
- MS-109-2025
- Conditions
- Severe Obesity, Port-Site Hernia, Postoperative Pain
- Keywords
- Sleeve Gastrectomy, Metabolic Bariatric Surgery, Trocar-Site Hernia, Port Closure, Fascial Closure, Postoperative Pain, Quality of Recovery-15, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 5 Nov 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 randomized controlled trial compared closure versus non-closure of the fascia at the working port (trocar) sites during laparoscopic sleeve gastrectomy for severe obesity.
A total of 160 adult patients undergoing laparoscopic sleeve gastrectomy at Kasr Al Ainy Hospital, Cairo University, were randomly allocated (1:1) to non-closure of the working ports (skin closure only) or fascial closure of the working ports using a fascial closure device.
Patients were followed for one year for the development of port-site hernia. Postoperative pain was assessed with the Visual Analogue Scale (VAS) at one week and one month, and functional recovery with the Quality of Recovery-15 (QoR-15) score at one week.
Detailed description
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed metabolic bariatric procedures. Port-site complications remain clinically important after laparoscopic surgery, particularly port-site hernia and postoperative pain. Fascial closure of trocar sites measuring 10 mm or larger is traditionally recommended to reduce the risk of port-site hernia; however, fascial closure may increase postoperative pain and delay functional recovery.
Aim: To compare closure versus non-closure of the working ports during laparoscopic sleeve gastrectomy with respect to port-site hernia occurrence, postoperative pain severity, and functional recovery measured by the QoR-15 score.
Design and setting: Single-centre, parallel-group randomized controlled trial conducted at Kasr Al Ainy Hospital, General Surgery Department, Faculty of Medicine, Cairo University.
Study period: Patients were enrolled from October 2024 to June 2025 and followed for one year after surgery; data collection was completed at the end of May 2026.
Randomization: An online randomization program (randomizer.org) was used to generate a random list, and each patient's allocation code was kept in an opaque sealed envelope. Patients were allocated in a 1:1 ratio to two parallel groups:
- Group A (n = 80): non-closure of the working ports (skin closure only).
- Group B (n = 80): closure of the working ports using a fascial closure device (Karl Storz SE \& Co. KG, Tuttlingen, Germany).
Preoperative assessment: Full history and clinical examination, anthropometric measurements (weight, BMI), routine laboratory investigations (complete blood count, liver and kidney function tests, coagulation profile, blood glucose, lipid profile), chest radiography, electrocardiography, anaesthetic assessment, and nutritional and psychological evaluation.
Operative technique: All operations were performed under balanced general anaesthesia with a transversus abdominis plane (TAP) block, in the supine position, with reverse Trendelenburg positioning after trocar insertion. Pneumoperitoneum was established with a Veress needle and trocars were inserted under direct vision. Dissection began approximately 4-6 cm proximal to the pylorus; the gastrocolic ligament and greater-curvature vessels were divided with an energy device and the fundus was fully mobilized up to the angle of His. A 36 Fr calibration bougie was placed along the lesser curvature and sequential stapler firings created the sleeve. Haemostasis and sleeve configuration were checked, and a methylene blue leak test was performed.
Port closure: In Group A only skin closure of the working port sites was performed. In Group B the fascial edges of the working ports were approximated under direct laparoscopic vision with the fascial closure device before skin closure.
Postoperative care: Standard care for all patients, including intravenous fluids, analgesia, early ambulation, venous thromboembolism prophylaxis and gradual oral intake according to the bariatric protocol.
Follow-up: Port-site pain at 1 week and 1 month; functional recovery (QoR-15) at 1 week; clinical examination for port-site hernia at each visit and abdominal wall ultrasound at 1 year.
Statistical analysis: Quantitative variables are expressed as mean and standard deviation and compared with Student's t-test; qualitative variables are expressed as number and percentage and compared with the chi-square or Fisher exact test. P < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients scheduled for laparoscopic sleeve gastrectomy were randomly allocated (1:1) to two parallel groups: non-closure of the working ports (skin closure only) versus fascial closure of the working ports with a fascial closure device.
| Arm | Type | Receives |
|---|---|---|
| Group A: Non-closure of working ports | Experimental | Procedure: Non-closure of working port fascia (skin closure only)Laparoscopic sleeve gastrectomy with non-closure of the fascia at the working port sites; only skin closure is performed using standard suturing techniques. |
| Group B: Closure of working ports | Active comparator | Procedure: Fascial closure of working portsLaparoscopic sleeve gastrectomy with fascial closure of the working port sites using a fascial closure device (Karl Storz SE \& Co. KG, Tuttlingen, Germany) under direct laparoscopic vision, followed by skin closure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients scheduled for laparoscopic sleeve gastrectomy
- Age between 18 and 60 years at the time of surgery
- Body mass index (BMI) greater than 35 kg/m2, or greater than 30 kg/m2 with significant obesity-related comorbidity
- Failure of adequate conservative management, including dietary modification, exercise and/or medical therapy, for at least six months
- Psychological stability and acceptance of surgical risks
Key exclusion criteria (8 listed)
- Pre-existing nutritional deficiency
- Pregnancy or lactation
- Significant long-standing cardiac or pulmonary disease
- Severe systemic illness
- Active substance or alcohol abuse
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 |
|---|---|---|
| Non-closure of working port fascia (skin closure only)At the end of laparoscopic sleeve gastrectomy, the fascial defects of the working ports are left unclosed and only the skin is closed using standard suturing techniques. | Procedure or surgery | Group A: Non-closure of working ports |
| Fascial closure of working portsAlso: Trocar-site fascial closureAt the end of laparoscopic sleeve gastrectomy, the fascial edges of the working port sites are approximated under direct laparoscopic vision using a fascial closure device (Karl Storz SE \& Co. KG, Tuttlingen, Germany), followed by skin closure. | Procedure or surgery | Group B: Closure of working ports |
Primary outcome
Incidence of port-site hernia
Time frame: 12 months after surgery
Number and percentage of patients who developed a port-site (trocar-site) hernia at the working port sites. Diagnosis was based on clinical examination at each follow-up visit (presence of swelling at the trocar site) with radiological confirmation by abdominal wall ultrasound at 1 year.
2 secondary outcomes
Postoperative port-site pain (Visual Analogue Scale)
Time frame: 1 week and 1 month after surgery
Functional recovery (Quality of Recovery-15 score)
Time frame: 1 week 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 5 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data publicly available. De-identified data may be shared by the principal investigator upon reasonable request.
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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.
Ahmed Mohamed Abdelsalam principal investigator
Cairo University
Mohamed Hassan Ali Fahmy study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-closure of working port fascia (skin closure only) and Fascial closure of working ports in people with Severe Obesity and Port-Site Hernia, 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 5 inclusion and 8 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 5 Nov 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 port-site hernia (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.