An interventional study of Non-closure of working port fascia (skin closure only) and Fascial closure of working ports in Severe Obesity, Port-Site Hernia and Postoperative Pain, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Prevention
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.
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:
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's enrollment of 160 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Laparoscopic sleeve gastrectomy with non-closure of the fascia at the working port sites; only skin closure is performed using standard suturing techniques.
Procedure: Non-closure of working port fascia (skin closure only)
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.
Procedure: Fascial closure of working ports
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.
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.
Also known as: Trocar-site fascial closure
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.
Time frame: 12 months after surgery
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.
Time frame: 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.
Time frame: 1 week after surgery
Plan to share: 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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