Laparoscopic Incision Closure s in Obese Patients — LICOP  

Obesity Clinical Trial

Official title: Laparoscopic Incision Closure Following Gynecological Benign Surgeries in Obese Patients

Status Recruiting

Clinical Trial Summary

Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. Studies comparing laparoscopic incision closure in bariatric population are limited .This is a prospective study that will be conducted in a single tertiary medical center. s obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women.

Clinical Trial Description

Laparoscopic surgery has become the standard of care for surgical procedures across multiple specialties, reducing perioperative complications, accelerating recovery and providing superior cosmetic results. Trocars are used in laparoscopic procedures to provide a portal for the placement of surgical instruments. Typically, three to four or more trocars of different sizes ranging from 5 to 15 mm in diameter are used in abdominal and pelvic surgery.

Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. The skin closure method should aim to keep the skin closely opposed during the hemostatic and inflammatory healing phases until the overlapping proliferative phase is able to provide tensile strength. The choice of technique is often based on the surgeon's personal experience. and is largely dependent on training exposure and local opinion. There is currently no consensus as to the optimal method of closure of the skin following laparoscopic surgery.

Previous meta-analyses examining skin closure methods for all surgical wounds have found suture to have significantly decreased rates of wound dehiscence compared to tissue adhesive. Meta-analysis published recently by Aitchison et al. compared between sutures, tissue adhesives and adhesive paper tape. They reported no difference in patient-evaluated cosmesis, prolonged pain, or patient satisfaction between the three groups. Nevertheless, no data specifically address the obese population.

Port-site trocar incision closure is a challenging procedure in laparoscopic surgeries, particularly in patients with clinically severe (morbid) obesity. Complications related to port-site trocars, even if uncommon, may have severe consequences that can lead to reoperation and permanent damage Studies comparing laparoscopic incision closure in bariatric population are limited. Fecso et al conducted a retrospective cohort study including 1579 bariatric patients, of them 494 were treated with tissue adhesive for skin closure. They reported that the use of tissue adhesive was more common in patients who developed incisional surgical site infection compared with those without incisional surgical site infection (SSI) (54.3 vs. 30.8%, p = 0.003).

Our department usually practice subcuticular and adhesive glue for the closure of laparoscopic incisions, based on surgeon's preference. As obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women.

Material and Methods This is a prospective study that will be conducted in a single tertiary medical center. Study population will include all women undergoing gynecologic laparoscopic surgery with BMI of 30 kg/m² or above. Women with connective tissue disease will be excluded from the study.

Intervention:

1. Each woman will undergo both interventions therefore will serve as her own control. All ports up to 8 mm (following robotic or conventional laparoscopy) will be eligible for inclusion in the study. The umbilicus will serve as a reference separating the right and left side incisions. Each side will be closed randomly using one of the two techniques. Randomizing the closure technique will be done based on the serial number given to each woman on recruitment (En block randomization) :

Odd serial number: Right side - subcuticular suturing, Left side- adhesive glue Even numbers: Right side- adhesive glue, Left side- subcuticular suturing

2. Incisions would be closed by one or the other following techniques: 1- Subcuticular closure- using 4-0 Monocryl suture will be used; 2- Adhesive glue (Dermabond).

3. On follow up visit 2- and 8-weeks post operation - each woman will complete the validated Patient Scar Assessment Questionnaire (PSAQ) on follow-up at 2- and 8-weeks post operation for the right and left side of the abdomen(10). The PSAQ consists of 4 scored subscales: Appearance, Consciousness, Appearance Satisfaction, and Symptom Satisfaction. Each subscale has a set of questions with a 4-point categorical response (1=most favorable, 4=least favorable). The sum of the scores quantifies each subscale.

Demographic and clinical characteristics will be collected from women's medical files. Operative and post-operative data will be collected including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus). ;

Related Conditions & MeSH terms

• Incision, Surgical
• Obesity
• Surgical Wound

• NCT number: NCT05622110
• Study type: Interventional
• Source: The University of Texas Health Science Center, Houston
• Contact: Aya Mohr-Sasson, M.D
• Phone: 13462704682
• Email: aya.mohrsasson@uth.tmc.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2023
• Completion date: December 2024